Primary completion· ClinicalTrials.gov
VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study
Risankizumab History and Updates
226 events · 2014 – present
Synced daily from openFDA and ClinicalTrials.gov. Last sync: .
23
FDA Approvals
0
Label Revisions
286
Trial Milestones
6
Pivotal Publications
Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-15Download chart as PNG
This page tracks every FDA action, clinical trial milestone, and major publication for Risankizumab since 2014, drawn from openFDA, ClinicalTrials.gov, and PubMed.
All published updates (12)
2026
- FDA approval (supplemental)Skyrizi (Risankizumab) Secures FDA Supplemental Efficacy Approval· Mar 6, 2026
- Results postedRisankizumab Shows Significant Improvement in Genital and Scalp Psoriasis· Feb 24, 2026
2025
- Results postedRisankizumab High-Dose Psoriasis Trial Shows Reduced Skin T Cells· Oct 24, 2025
- FDA approval (supplemental)Skyrizi (Risankizumab) Receives FDA Supplemental Approval for Efficacy· Sep 3, 2025
- FDA approval (supplemental)FDA Approves Skyrizi (Risankizumab) Supplemental Application for Efficacy· Sep 3, 2025
- Results postedRisankizumab Phase 3 Trial: Pediatric Plaque Psoriasis PASI 75 Rates Up to 92.3%· May 20, 2025
2024
- Pivotal publicationRisankizumab for Ulcerative Colitis: Two Randomized Trials Published· Jan 1, 2024
- Pivotal publicationRisankizumab vs. Ustekinumab for Moderate-to-Severe Crohn's Disease Published· Jan 1, 2024
2022
- Pivotal publicationRisankizumab Crohn's Disease Maintenance Therapy Trial Results Published· Jan 1, 2022
- Pivotal publicationRisankizumab Phase 3 ADVANCE and MOTIVATE Crohn's Disease Results Published· Jan 1, 2022
2019
- Pivotal publicationRisankizumab Compared to Adalimumab for Moderate-to-Severe Plaque Psoriasis· Jan 1, 2019
2018
- Pivotal publicationRisankizumab for Moderate-to-Severe Plaque Psoriasis Shows Efficacy and Safety· Jan 1, 2018
Upcoming & expected milestones
Trial started· ClinicalTrials.gov
Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
Primary completion· ClinicalTrials.gov
Pharmacokinetic, Safety, Tolerability, and Immunogenicity Comparison of CKD-704 (Risankizumab Biosimilar), With EU-approved Skyrizi®, and US
Primary completion· ClinicalTrials.gov
A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Ar
Primary completion· ClinicalTrials.gov
Risankizumab in Children With Crohn's Disease (RisaKids)
Primary completion· ClinicalTrials.gov
Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response
Primary completion· ClinicalTrials.gov
A Study to Assess How Intravenous and Subcutaneous Administrations of Risankizumab Moves Through the Body of Healthy Adult Participants
Primary completion· ClinicalTrials.gov
A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely
Primary completion· ClinicalTrials.gov
PATHFINDER: Evaluating the Optimal First-Line Treatment Strategy for Moderate-to-Severely Active Ileal-dominant Crohn's Disease
Primary completion· ClinicalTrials.gov
A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab
Primary completion· ClinicalTrials.gov
Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
Primary completion· ClinicalTrials.gov
Fluorescence Imaging of Adalimumab-680LT and Risankizumab-800CW in Inflammatory Bowel Disease
Primary completion· ClinicalTrials.gov
Study of Targeted Therapies for the Treatment of Adult Participants With Active Psoriatic Arthritis
Primary completion· ClinicalTrials.gov
Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease
Primary completion· ClinicalTrials.gov
Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDA
Primary completion· ClinicalTrials.gov
Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 6 and 17 Years With Moderate to Severe Plaque Psoria
Primary completion· ClinicalTrials.gov
Risankizumab for Fibrostenotic Crohn's Disease Treatment
Primary completion· ClinicalTrials.gov
A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab
Primary completion· ClinicalTrials.gov
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis
Primary completion· ClinicalTrials.gov
A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
Primary completion· ClinicalTrials.gov
A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pe
Primary completion· ClinicalTrials.gov
Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease
Primary completion· ClinicalTrials.gov
Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
Primary completion· ClinicalTrials.gov
Costa Rican Registry of IL-23 Inhibitors in Psoriatic Disease
Primary completion· ClinicalTrials.gov
Study to Evaluate Pregnancy Outcomes in Risankizumab Exposed Pregnancies Relative to Those Non-risankizumab Exposed Pregnancies in Women Wit
Primary completion· ClinicalTrials.gov
A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis
Past events
2026
Trial started· ClinicalTrials.gov
Costa Rican Registry of IL-23 Inhibitors in Psoriatic Disease
Primary completion· ClinicalTrials.gov
A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease
Trial started· ClinicalTrials.gov
A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
Trial registered· ClinicalTrials.gov
A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
Primary completion· ClinicalTrials.gov
A Study to Learn How Safe and Effective Risankizumab is When Compared to Deucravacitinib to Treat Participants With Moderate Plaque Psoriasi
FDA approval (supplemental)· FDA
Sponsor: ABBVIE INC. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: ABBVIE INC. Class: Labeling.
Trial registered· ClinicalTrials.gov
A Study to Assess How Intravenous and Subcutaneous Administrations of Risankizumab Moves Through the Body of Healthy Adult Participants
Trial started· ClinicalTrials.gov
A Study to Assess How Intravenous and Subcutaneous Administrations of Risankizumab Moves Through the Body of Healthy Adult Participants
FDA approval (supplemental)· FDA
Sponsor: ABBVIE INC. Class: Efficacy.
FDA approval (supplemental)· FDA
Sponsor: ABBVIE INC. Class: Labeling.
Trial registered· ClinicalTrials.gov
Costa Rican Registry of IL-23 Inhibitors in Psoriatic Disease
Primary completion· ClinicalTrials.gov
Risankizumab Long-term Remission Study
Results posted· ClinicalTrials.gov
Study to Assess the Safety and Efficacy of Subcutaneously Injected Risankizumab in Adult Participants With Genital or Scalp Psoriasis
Primary completion· ClinicalTrials.gov
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis
Primary completion· ClinicalTrials.gov
A Study to Assess the Concentrations of Risankizumab in the Breast Milk of Adult Lactating Women With Inflammatory Bowel Disease
Trial registered· ClinicalTrials.gov
Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
Trial started· ClinicalTrials.gov
Fluorescence Imaging of Adalimumab-680LT and Risankizumab-800CW in Inflammatory Bowel Disease
Primary completion· ClinicalTrials.gov
A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled Syringe or an On-Bod
Trial started· ClinicalTrials.gov
Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
2025
Trial registered· ClinicalTrials.gov
Fluorescence Imaging of Adalimumab-680LT and Risankizumab-800CW in Inflammatory Bowel Disease
Trial registered· ClinicalTrials.gov
Pharmacokinetic, Safety, Tolerability, and Immunogenicity Comparison of CKD-704 (Risankizumab Biosimilar), With EU-approved Skyrizi®, and US
Trial started· ClinicalTrials.gov
Pharmacokinetic, Safety, Tolerability, and Immunogenicity Comparison of CKD-704 (Risankizumab Biosimilar), With EU-approved Skyrizi®, and US
Primary completion· ClinicalTrials.gov
A Study to Assess the Bioavailability of Risankizumab Following Subcutaneous Administration With Prefilled Pen Relative to a Prefilled Syrin
Primary completion· ClinicalTrials.gov
A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administration With On-Body Injector in Healthy Adult
Results posted· ClinicalTrials.gov
High Dose Risankizumab for Psoriasis
Trial started· ClinicalTrials.gov
Risankizumab for Fibrostenotic Crohn's Disease Treatment
Trial started· ClinicalTrials.gov
Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
Trial registered· ClinicalTrials.gov
Risankizumab for Fibrostenotic Crohn's Disease Treatment
FDA approval (supplemental)· FDA
Sponsor: ABBVIE INC. Class: Efficacy.
FDA approval (supplemental)· FDA
Sponsor: ABBVIE INC. Class: Efficacy.
Primary completion· ClinicalTrials.gov
Fluorescence Imaging of Risankizumab-800CW in Inflammatory Bowel Disease
Trial registered· ClinicalTrials.gov
Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
Trial started· ClinicalTrials.gov
A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis
Trial registered· ClinicalTrials.gov
A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis
Trial started· ClinicalTrials.gov
A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab
Trial started· ClinicalTrials.gov
A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled Syringe or an On-Bod
Trial registered· ClinicalTrials.gov
A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled Syringe or an On-Bod
Results posted· ClinicalTrials.gov
A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disea
Primary completion· ClinicalTrials.gov
Risankizumab Long-term Remission Study
Trial started· ClinicalTrials.gov
A Study to Assess the Bioavailability of Risankizumab Following Subcutaneous Administration With Prefilled Pen Relative to a Prefilled Syrin
FDA approval (supplemental)· FDA
Sponsor: ABBVIE INC. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: ABBVIE INC. Class: Labeling.
Trial registered· ClinicalTrials.gov
A Study to Assess the Bioavailability of Risankizumab Following Subcutaneous Administration With Prefilled Pen Relative to a Prefilled Syrin
Trial registered· ClinicalTrials.gov
A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administration With On-Body Injector in Healthy Adult
Trial started· ClinicalTrials.gov
A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administration With On-Body Injector in Healthy Adult
Primary completion· ClinicalTrials.gov
A Study to Assess the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syri
Trial started· ClinicalTrials.gov
Study of Targeted Therapies for the Treatment of Adult Participants With Active Psoriatic Arthritis
Trial registered· ClinicalTrials.gov
A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab
Trial registered· ClinicalTrials.gov
Study of Targeted Therapies for the Treatment of Adult Participants With Active Psoriatic Arthritis
Primary completion· ClinicalTrials.gov
A Study to Assess Pharmacokinetic Exposures Following Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants
Primary completion· ClinicalTrials.gov
Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis
Primary completion· ClinicalTrials.gov
Study to Assess the Safety and Efficacy of Subcutaneously Injected Risankizumab in Adult Participants With Genital or Scalp Psoriasis
Results posted· ClinicalTrials.gov
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participa
2024
Results posted· ClinicalTrials.gov
A Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis ( LIMMITLESS )
Trial started· ClinicalTrials.gov
Fluorescence Imaging of Risankizumab-800CW in Inflammatory Bowel Disease
Trial started· ClinicalTrials.gov
Risankizumab in Children With Crohn's Disease (RisaKids)
Trial started· ClinicalTrials.gov
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis
Trial registered· ClinicalTrials.gov
Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response
Trial started· ClinicalTrials.gov
Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response
Trial registered· ClinicalTrials.gov
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis
Trial registered· ClinicalTrials.gov
Fluorescence Imaging of Risankizumab-800CW in Inflammatory Bowel Disease
Trial started· ClinicalTrials.gov
A Study to Assess the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syri
Trial started· ClinicalTrials.gov
Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease
Trial registered· ClinicalTrials.gov
A Study to Assess the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syri
Trial registered· ClinicalTrials.gov
Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease
Trial started· ClinicalTrials.gov
A Study to Assess Pharmacokinetic Exposures Following Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants
Trial started· ClinicalTrials.gov
A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Ar
Trial registered· ClinicalTrials.gov
A Study to Assess Pharmacokinetic Exposures Following Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants
FDA approval (supplemental)· FDA
Sponsor: ABBVIE INC. Class: Efficacy.
FDA approval (supplemental)· FDA
Sponsor: ABBVIE INC. Class: Efficacy.
Results posted· ClinicalTrials.gov
Study of Subcutaneous (Injected Under the Skin) Risankizumab to Assess Change in Disease Symptoms in Adult Participants With Moderate to Sev
Trial started· ClinicalTrials.gov
A Study to Learn How Safe and Effective Risankizumab is When Compared to Deucravacitinib to Treat Participants With Moderate Plaque Psoriasi
Primary completion· ClinicalTrials.gov
A Study to Compare the Bioavailability of Intravenously Infused Risankizumab Manufactured by Two Different Processes in Healthy Adults
Results posted· ClinicalTrials.gov
Study of Subcutaneous Risankizumab Injection Compared to Oral Apremilast Tablets to Assess Change in Disease Activity And Adverse Events in
Trial started· ClinicalTrials.gov
A Study to Assess the Concentrations of Risankizumab in the Breast Milk of Adult Lactating Women With Inflammatory Bowel Disease
Trial registered· ClinicalTrials.gov
A Study to Assess the Concentrations of Risankizumab in the Breast Milk of Adult Lactating Women With Inflammatory Bowel Disease
Trial registered· ClinicalTrials.gov
A Study to Learn How Safe and Effective Risankizumab is When Compared to Deucravacitinib to Treat Participants With Moderate Plaque Psoriasi
Trial started· ClinicalTrials.gov
VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study
Trial registered· ClinicalTrials.gov
Risankizumab in Children With Crohn's Disease (RisaKids)
FDA approval (supplemental)· FDA
Sponsor: ABBVIE INC. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: ABBVIE INC. Class: Labeling.
Primary completion· ClinicalTrials.gov
A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disea
Trial registered· ClinicalTrials.gov
VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study
FDA approval (supplemental)· FDA
Sponsor: ABBVIE INC. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: ABBVIE INC. Class: Labeling.
Pivotal publication· PubMed
COMMAND — A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis
Pivotal publication· PubMed
SEQUENCE — Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Dis
2023
Trial started· ClinicalTrials.gov
A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pe
Primary completion· ClinicalTrials.gov
A Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis ( LIMMITLESS )
Trial started· ClinicalTrials.gov
A Study to Compare the Bioavailability of Intravenously Infused Risankizumab Manufactured by Two Different Processes in Healthy Adults
Trial started· ClinicalTrials.gov
A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely
Trial registered· ClinicalTrials.gov
A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Ar
Trial started· ClinicalTrials.gov
PATHFINDER: Evaluating the Optimal First-Line Treatment Strategy for Moderate-to-Severely Active Ileal-dominant Crohn's Disease
Trial registered· ClinicalTrials.gov
A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely
Trial registered· ClinicalTrials.gov
A Study to Compare the Bioavailability of Intravenously Infused Risankizumab Manufactured by Two Different Processes in Healthy Adults
Trial registered· ClinicalTrials.gov
A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pe
Trial started· ClinicalTrials.gov
Study to Assess the Safety and Efficacy of Subcutaneously Injected Risankizumab in Adult Participants With Genital or Scalp Psoriasis
Primary completion· ClinicalTrials.gov
High Dose Risankizumab for Psoriasis
Trial registered· ClinicalTrials.gov
Study to Assess the Safety and Efficacy of Subcutaneously Injected Risankizumab in Adult Participants With Genital or Scalp Psoriasis
Trial registered· ClinicalTrials.gov
PATHFINDER: Evaluating the Optimal First-Line Treatment Strategy for Moderate-to-Severely Active Ileal-dominant Crohn's Disease
Primary completion· ClinicalTrials.gov
Study to Evaluate the Relative Bioavailability of Two Risankizumab Drug Product Presentations in Healthy Volunteers.
Primary completion· ClinicalTrials.gov
Study of Subcutaneous (Injected Under the Skin) Risankizumab to Assess Change in Disease Symptoms in Adult Participants With Moderate to Sev
Primary completion· ClinicalTrials.gov
Study of Subcutaneous Risankizumab Injection Compared to Oral Apremilast Tablets to Assess Change in Disease Activity And Adverse Events in
Results posted· ClinicalTrials.gov
A Study of the Safety and Efficacy of Risankizumab in Adult Participants With Plaque Psoriasis Who Have Had a Suboptimal Response to Secukin
2022
Results posted· ClinicalTrials.gov
ACTIV-5 / Big Effect Trial (BET-A) for the Treatment of COVID-19
Primary completion· ClinicalTrials.gov
Study of Subcutaneous Risankizumab Injection to Assess Change in Palmoplantar Pustulosis Area and Severity Index [PPPASI] in Adult Japanese
Primary completion· ClinicalTrials.gov
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participa
Primary completion· ClinicalTrials.gov
A Study to Evaluate the Effect of Intravenous (IV) Infusions of Risankizumab on Pharmacokinetics of Cytochome P450 Substrates in Adult Parti
Trial registered· ClinicalTrials.gov
Study to Evaluate the Relative Bioavailability of Two Risankizumab Drug Product Presentations in Healthy Volunteers.
Trial started· ClinicalTrials.gov
Study to Evaluate the Relative Bioavailability of Two Risankizumab Drug Product Presentations in Healthy Volunteers.
FDA approval (supplemental)· FDA
Sponsor: ABBVIE INC. Class: Efficacy.
FDA approval (supplemental)· FDA
Sponsor: ABBVIE INC. Class: Labeling.
Results posted· ClinicalTrials.gov
A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Results posted· ClinicalTrials.gov
A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
Primary completion· ClinicalTrials.gov
A Study of Guselkumab and Risankizumab in Healthy Participants and Participants With Psoriatic Arthritis
FDA approval (supplemental)· FDA
Sponsor: ABBVIE INC. Class: Efficacy.
FDA approval· FDA
Sponsor: ABBVIE INC. Class: Type 3 - New Dosage Form.
Results posted· ClinicalTrials.gov
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prio
Trial registered· ClinicalTrials.gov
A Study in Healthy Japanese and Caucasian Subjects to Assess the Pharmacokinetics, Safety and Tolerability of Risankizumab
Trial registered· ClinicalTrials.gov
A Study to Evaluate the Bioavailability of Risankizumab Following Subcutaneous Dosing in Healthy Male Participants
Trial registered· ClinicalTrials.gov
A Study to Evaluate the Bioavailability of Risankizumab in Pre-filled Syringe or Auto-injector in Healthy Adult Participants
Trial registered· ClinicalTrials.gov
High Dose Risankizumab for Psoriasis
Trial registered· ClinicalTrials.gov
Study to Evaluate the Effect of Different Warm-Up Times of Risankizumab Autoinjector (AI) on the Injection Pain Experiences in Healthy Volun
Primary completion· ClinicalTrials.gov
Study to Assess Adverse Events When Subcutaneous Risankizumab Injection is Given to Adult Participants With Psoriasis in Real World Setting
Trial registered· ClinicalTrials.gov
Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants
Trial registered· ClinicalTrials.gov
A Study of Intravenously (IV) Infused or Subcutaneously (SC) Injected Risankizumab in Healthy Adult Participants in China
Results posted· ClinicalTrials.gov
A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate R
Trial started· ClinicalTrials.gov
High Dose Risankizumab for Psoriasis
Results posted· ClinicalTrials.gov
A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to
Primary completion· ClinicalTrials.gov
Exploring the Effects of IL-23 Inhibition by Risankizumab on Psoriasis Autoimmunity
FDA approval (supplemental)· FDA
Sponsor: ABBVIE INC. Class: Efficacy.
Primary completion· ClinicalTrials.gov
A Study of the Safety and Efficacy of Risankizumab in Adult Participants With Plaque Psoriasis Who Have Had a Suboptimal Response to Secukin
Pivotal publication· PubMed
FORTIFY — A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease
Pivotal publication· PubMed
A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
2021
Primary completion· ClinicalTrials.gov
A Study Comparing the Safety and Efficacy of Risankizumab to Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis
Results posted· ClinicalTrials.gov
A Study to Evaluate Risankizumab in Adults and Adolescents With Moderate to Severe Atopic Dermatitis
Trial started· ClinicalTrials.gov
A Study of Guselkumab and Risankizumab in Healthy Participants and Participants With Psoriatic Arthritis
Trial registered· ClinicalTrials.gov
A Study of Guselkumab and Risankizumab in Healthy Participants and Participants With Psoriatic Arthritis
Primary completion· ClinicalTrials.gov
ACTIV-5 / Big Effect Trial (BET-A) for the Treatment of COVID-19
Trial started· ClinicalTrials.gov
Study to Evaluate Pregnancy Outcomes in Risankizumab Exposed Pregnancies Relative to Those Non-risankizumab Exposed Pregnancies in Women Wit
Trial started· ClinicalTrials.gov
Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 6 and 17 Years With Moderate to Severe Plaque Psoria
Results posted· ClinicalTrials.gov
Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis
Primary completion· ClinicalTrials.gov
Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants
Trial started· ClinicalTrials.gov
Study to Assess Adverse Events When Subcutaneous Risankizumab Injection is Given to Adult Participants With Psoriasis in Real World Setting
Trial started· ClinicalTrials.gov
Study of Subcutaneous Risankizumab Injection Compared to Oral Apremilast Tablets to Assess Change in Disease Activity And Adverse Events in
Trial registered· ClinicalTrials.gov
Study of Subcutaneous Risankizumab Injection Compared to Oral Apremilast Tablets to Assess Change in Disease Activity And Adverse Events in
Results posted· ClinicalTrials.gov
A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis
Trial registered· ClinicalTrials.gov
Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 6 and 17 Years With Moderate to Severe Plaque Psoria
FDA approval (supplemental)· FDA
Sponsor: ABBVIE INC. Class: Efficacy.
FDA approval (supplemental)· FDA
Sponsor: ABBVIE INC. Class: Efficacy.
Trial registered· ClinicalTrials.gov
Study to Evaluate Pregnancy Outcomes in Risankizumab Exposed Pregnancies Relative to Those Non-risankizumab Exposed Pregnancies in Women Wit
Trial started· ClinicalTrials.gov
Risankizumab Long-term Remission Study
Primary completion· ClinicalTrials.gov
Study to Evaluate the Effect of Different Warm-Up Times of Risankizumab Autoinjector (AI) on the Injection Pain Experiences in Healthy Volun
Trial registered· ClinicalTrials.gov
Study to Assess Adverse Events When Subcutaneous Risankizumab Injection is Given to Adult Participants With Psoriasis in Real World Setting
Results posted· ClinicalTrials.gov
A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis
Trial started· ClinicalTrials.gov
Study of Subcutaneous (Injected Under the Skin) Risankizumab to Assess Change in Disease Symptoms in Adult Participants With Moderate to Sev
Primary completion· ClinicalTrials.gov
A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Trial started· ClinicalTrials.gov
Exploring the Effects of IL-23 Inhibition by Risankizumab on Psoriasis Autoimmunity
Trial registered· ClinicalTrials.gov
Exploring the Effects of IL-23 Inhibition by Risankizumab on Psoriasis Autoimmunity
Trial registered· ClinicalTrials.gov
Study of Subcutaneous (Injected Under the Skin) Risankizumab to Assess Change in Disease Symptoms in Adult Participants With Moderate to Sev
2020
Primary completion· ClinicalTrials.gov
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prio
Trial registered· ClinicalTrials.gov
Risankizumab Long-term Remission Study
Primary completion· ClinicalTrials.gov
A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
Primary completion· ClinicalTrials.gov
A Study to Evaluate Risankizumab in Adults and Adolescents With Moderate to Severe Atopic Dermatitis
Trial started· ClinicalTrials.gov
ACTIV-5 / Big Effect Trial (BET-A) for the Treatment of COVID-19
Trial registered· ClinicalTrials.gov
ACTIV-5 / Big Effect Trial (BET-A) for the Treatment of COVID-19
Primary completion· ClinicalTrials.gov
A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to
Trial started· ClinicalTrials.gov
Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDA
Trial started· ClinicalTrials.gov
Study to Evaluate the Effect of Different Warm-Up Times of Risankizumab Autoinjector (AI) on the Injection Pain Experiences in Healthy Volun
Trial started· ClinicalTrials.gov
Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants
Trial registered· ClinicalTrials.gov
Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDA
Trial started· ClinicalTrials.gov
Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis
Trial started· ClinicalTrials.gov
Study of Subcutaneous Risankizumab Injection to Assess Change in Palmoplantar Pustulosis Area and Severity Index [PPPASI] in Adult Japanese
Trial started· ClinicalTrials.gov
A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disea
Primary completion· ClinicalTrials.gov
Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis
Trial registered· ClinicalTrials.gov
Study of Subcutaneous Risankizumab Injection to Assess Change in Palmoplantar Pustulosis Area and Severity Index [PPPASI] in Adult Japanese
Primary completion· ClinicalTrials.gov
A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate R
Trial registered· ClinicalTrials.gov
A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disea
Trial started· ClinicalTrials.gov
A Study to Evaluate the Effect of Intravenous (IV) Infusions of Risankizumab on Pharmacokinetics of Cytochome P450 Substrates in Adult Parti
Primary completion· ClinicalTrials.gov
A Study of Intravenously (IV) Infused or Subcutaneously (SC) Injected Risankizumab in Healthy Adult Participants in China
Results posted· ClinicalTrials.gov
A Long Term Extension Trial of BI 655066/ABBV-066 (Risankizumab), in Patients With Moderately to Severely Active Crohn's Disease
Primary completion· ClinicalTrials.gov
A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis
Trial registered· ClinicalTrials.gov
Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis
FDA approval (supplemental)· FDA
Sponsor: ABBVIE INC. Class: Labeling.
Primary completion· ClinicalTrials.gov
A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis
Primary completion· ClinicalTrials.gov
Risankizumab Therapy Versus Placebo for Subjects With Psoriasis in the Russian Federation
Trial registered· ClinicalTrials.gov
A Study to Evaluate the Effect of Intravenous (IV) Infusions of Risankizumab on Pharmacokinetics of Cytochome P450 Substrates in Adult Parti
2019
Trial started· ClinicalTrials.gov
A Study of the Safety and Efficacy of Risankizumab in Adult Participants With Plaque Psoriasis Who Have Had a Suboptimal Response to Secukin
Primary completion· ClinicalTrials.gov
A Study to Evaluate the Bioavailability of Risankizumab in Pre-filled Syringe or Auto-injector in Healthy Adult Participants
Results posted· ClinicalTrials.gov
Extension Trial Assessing the Safety and Efficacy of BI 655066/ABBV-066/Risankizumab in Patients With Moderate to Severe Chronic Plaque Psor
Trial registered· ClinicalTrials.gov
A Study of the Safety and Efficacy of Risankizumab in Adult Participants With Plaque Psoriasis Who Have Had a Suboptimal Response to Secukin
Results posted· ClinicalTrials.gov
A Study to Assess the Efficacy of Risankizumab Compared to FUMADERM® in Subjects With Moderate to Severe Plaque Psoriasis Who Are Naïve to a
Results posted· ClinicalTrials.gov
BI 655066 Versus Placebo & Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis
Trial started· ClinicalTrials.gov
A Study of Intravenously (IV) Infused or Subcutaneously (SC) Injected Risankizumab in Healthy Adult Participants in China
Primary completion· ClinicalTrials.gov
A Long Term Extension Trial of BI 655066/ABBV-066 (Risankizumab), in Patients With Moderately to Severely Active Crohn's Disease
Results posted· ClinicalTrials.gov
BI 655066 (Risankizumab) Compared to Placebo and Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasi
Trial started· ClinicalTrials.gov
A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis
Trial started· ClinicalTrials.gov
A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Results posted· ClinicalTrials.gov
BI 655066 (Risankizumab) Proof of Concept Dose Finding Study in Ankylosing Spondylitis (AS)
Sources
FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.