What Is Deucravacitinib?
Deucravacitinib is an FDA-approved medication for plaque psoriasis. It is primarily studied as an oral treatment, often administered in tablet form. The drug has been investigated in 53 clinical trials, enrolling a total of 18,263 participants. The first trial for deucravacitinib began on February 26, 2021, with ongoing research projected to continue until at least May 4, 2026. While approved for plaque psoriasis, deucravacitinib is also being explored for other inflammatory and autoimmune conditions. In some studies, deucravacitinib is being tested using a microdevice, a small device designed to evaluate drug reactions directly on skin conditions. This innovative approach aims to understand how the skin reacts to treatments, including those like deucravacitinib, which are approved for conditions such as psoriasis.
Uses and Conditions Under Study
Deucravacitinib is being studied for a variety of inflammatory and autoimmune conditions, with a strong focus on psoriasis and related disorders. These conditions often involve immune system overactivity leading to skin inflammation or joint issues.
- Psoriasis and Related Conditions: A significant portion of research, totaling 23 trials, focuses on psoriasis. This includes 11 trials for Psoriasis, 9 trials for Plaque Psoriasis, 2 trials for Psoriatic Arthritis, 2 trials for Palmoplantar Pustulosis, and 1 trial for Genital Psoriasis. Psoriasis is a chronic skin condition causing red, scaly patches, while plaque psoriasis is its most common form. Psoriatic arthritis affects joints, and palmoplantar pustulosis causes pustules on hands and feet. Genital psoriasis specifically affects the genital area.
- Other Autoimmune and Inflammatory Conditions: Deucravacitinib is also being investigated for other conditions where immune system modulation may be beneficial. This includes 2 trials for Systemic Lupus Erythematosus, an autoimmune disease affecting multiple organs. Additionally, there is 1 trial for Frontal Fibrosing Alopecia, a type of hair loss, 1 trial for Granuloma Annulare, a chronic skin condition causing raised bumps, and 1 trial for Genodermatosis, a group of inherited skin disorders.
- Studies in Healthy Participants: To understand the drug's safety, tolerability, and how it is processed by the body (pharmacokinetics), deucravacitinib is also being studied in 3 trials involving healthy individuals.
Dosing
Deucravacitinib is primarily administered as an oral treatment, typically in tablet form. Clinical trials have explored various dosing regimens and strengths for different conditions.
- Standard Doses: Common investigational doses include 6mg once daily and 12mg once daily. For instance, one study investigated a 12mg once-daily oral treatment for 48 weeks, while another explored 6mg once a day for 6 months.
- Investigational Approaches: Beyond specific milligram doses, studies have also referred to "Deucravacitinib, Dose 1" and "Deucravacitinib, Dose 2," as well as "standard dose" and "half-standard dose," indicating a range of strengths are being evaluated.
- Administration: The drug is generally taken once a day. Some studies specify "specified dose on specified days," suggesting flexible dosing schedules depending on the trial design and condition being treated.
- Novel Delivery: In addition to oral tablets, deucravacitinib has been part of studies involving an "in situ cutaneous microdevice." This small device is designed to test drugs directly on the skin, rather than for systemic administration, to observe localized reactions.
Side Effects
In clinical trials, the most common side effect reported by patients taking Deucravacitinib was upper respiratory tract infection. This occurred in 8.9% of patients on Deucravacitinib, compared to 6.8% of patients receiving placebo. This data was gathered from 7 trials involving 1772 participants in the Deucravacitinib arm.
Other common side effects experienced by patients on Deucravacitinib, compared to placebo, included:
- Nasopharyngitis: 7.5% on Deucravacitinib vs 7.5% on placebo (across 7 trials, n=1772).
- Diarrhea: 4.1% on Deucravacitinib vs 3.3% on placebo (across 3 trials, n=1208).
- Cough: 4.3% on Deucravacitinib vs 1.4% on placebo (across 2 trials, n=94).
- Psoriasis: 4.3% on Deucravacitinib vs 2.5% on placebo (across 1 trial, n=94).
- Sinusitis: 3.1% on Deucravacitinib vs 1.4% on placebo (across 4 trials, n=255).
- Urinary tract infection: 2.1% on Deucravacitinib vs 1.6% on placebo (across 3 trials, n=1208).
Some events, such as headache (3.0% on Deucravacitinib vs 3.4% on placebo) and psoriatic arthropathy (2.4% on Deucravacitinib vs 3.4% on placebo), occurred at slightly lower rates in the Deucravacitinib group compared to placebo. Hypertension occurred at an equal rate (3.0% on Deucravacitinib vs 3.0% on placebo).
Clinical Trial Results
Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)
In a study (NCT04857034) evaluating Deucravacitinib for active DLE/SCLE, participants showed significant improvement in skin disease activity. The mean change from baseline in the CLASI-A Score (where lower scores indicate improvement) was -9.8 for one Deucravacitinib treatment group and -7.5 for another, compared to -4.3 for placebo during the placebo-controlled period. Furthermore, 60.0% of participants on one Deucravacitinib treatment achieved at least a 50% improvement in CLASI-A score (CLASI-50), and 54.2% on another, compared to 21.7% on placebo. A complete response (CLASI-A score of 0) was achieved by 12.0% of participants in one Deucravacitinib group and 4.2% in another, versus 0% on placebo.
Crohn's Disease or Ulcerative Colitis
A long-term study (NCT04877990) assessed the safety and efficacy of Deucravacitinib in participants with Crohn's disease or ulcerative colitis. The trial primarily reported on changes from baseline in electrocardiogram (ECG), laboratory, and vital sign parameters. Most mean changes in these parameters were small, and the number of participants experiencing clinically significant abnormalities in ECG, laboratory tests, or vital signs was generally low across both Crohn's disease and ulcerative colitis groups.
Psoriatic Arthritis (PsA)
Two studies investigated Deucravacitinib in psoriatic arthritis. In one study (NCT04908189), Deucravacitinib demonstrated improvements across several measures at Week 16 (assuming an approximate arm size of 300 participants for calculations):
- 56.3% of participants on Deucravacitinib achieved an ACR 20 response, compared to 41.0% on placebo.
- 30.0% achieved an ACR 50 response, compared to 17.0% on placebo.
- 21.0% achieved a PASI 75 response, compared to 7.7% on placebo.
- The mean change from baseline in the DAS28-CRP score (lower is better) was -1.3133 for Deucravacitinib, compared to -0.9095 for placebo.
- 26.7% of participants achieved Minimal Disease Activity (MDA), compared to 15.3% on placebo.
Another study (NCT04908202) in biologic-naive PsA patients also showed positive results at Week 16:
- 54.2% of participants on Deucravacitinib achieved an ACR 20 response, compared to 34.1% on placebo.
- 51.9% achieved a PASI 75 response, compared to 7.1% on placebo.
- The mean change from baseline in the HAQ-DI score (lower is better) was -0.4103 for Deucravacitinib, compared to -0.2118 for placebo.
Moderate-to-severe Scalp Psoriasis
A study (NCT05478499) on moderate-to-severe scalp psoriasis showed that at Week 16, Deucravacitinib significantly improved scalp symptoms:
- 40.6% of participants on Deucravacitinib achieved a Psoriasis Scalp Severity Index 90 (PSSI 90), compared to 2.1% on placebo.
- 48.5% achieved a Scalp-specific Physician Global Assessment score of 0 or 1 (Ss-PGA 0/1), compared to 12.8% on placebo.
- The mean reduction in scalp-specific itch numerical rating scale (NRS) score was -3.3 for Deucravacitinib, compared to -0.7 for placebo, indicating a greater reduction in itch.
Currently Recruiting Trials
Deucravacitinib is currently being investigated in a variety of clinical trials, offering opportunities for patients to contribute to medical research. These studies aim to understand more about how Deucravacitinib works across different conditions, its safety, and its effectiveness.
For individuals with moderate to severe plaque psoriasis, several studies are actively recruiting. Bristol-Myers Squibb is sponsoring a Phase 3 study, NCT06979453, which seeks to enroll 366 adolescent participants to evaluate the drug's efficacy, safety, and drug levels. Another large Phase 3 study, NCT07116967 (PRAGMATYK), is comparing the long-term safety of Deucravacitinib against Ustekinumab in 3040 participants with psoriasis. Pediatric participants aged 4 to under 18 with moderate to severe plaque psoriasis can also join a Phase 3 study, NCT04772079, targeting 153 children and adolescents to assess drug levels, efficacy, and safety.
Beyond traditional clinical trials, several "real-world" observational studies are underway for psoriasis. These include NCT07256015, characterizing the experience of 200 patients in Italy, and NCT06701513 (RePhlect) in France, assessing effectiveness in 350 adults. A similar study in Japan, NCT06382987, is comparing Deucravacitinib to apremilast in 600 adults. Another large real-world study, NCT05744466, is comparing effectiveness against apremilast in 1500 adults with plaque psoriasis. For patients with moderate-to-severe plaque psoriasis in Korea, NCT06258668 is an observational study describing safety and effectiveness in 505 participants. A specialized real-world study, NCT06999941, is investigating Deucravacitinib in 50 patients with moderate to severe plaque psoriasis who also have eczematous features.
Deucravacitinib is also being studied for other conditions. A Phase 3 study, NCT06869551, is evaluating its drug levels, efficacy, and safety in 60 pediatric participants with juvenile psoriatic arthritis. For rare skin conditions, Mayo Clinic is conducting a Phase 2 study, NCT06444399, for Pityriasis Rubra Pilaris, enrolling 12 participants. The Centre Hospitalier Universitaire de Nice is running two Phase 2 studies: NCT06327321 for generalized vitiligo, targeting 128 participants, and NCT06136403 for inflammatory genodermatoses, with an enrollment of 10 adults.
Further research includes a study by Peking University People's Hospital, NCT07564271, exploring Deucravacitinib's mechanism in 10 adults with idiopathic inflammatory myopathies. The University of California, San Francisco, is conducting a Phase 4 study, NCT05858645, to assess immune cell function in 25 patients with psoriasis vulgaris before and after treatment. Finally, a study to assess Deucravacitinib safety in pregnancy, NCT07017699, is recruiting 900 pregnant participants exposed to the drug.
Where to Participate
Clinical trials for Deucravacitinib are accessible across a wide geographic area, with 166 sites located in 122 cities across 33 states. This broad reach helps ensure diverse participation in the research.
The top locations with multiple recruiting sites include:
- Phoenix, Arizona (5 sites)
- Miami, Florida (4 sites)
- Scottsdale, Arizona (4 sites)
- Birmingham, Alabama (3 sites)
- Sacramento, California (3 sites)
- Tampa, Florida (3 sites)
- Indianapolis, Indiana (3 sites)
- Los Angeles, California (3 sites)
- Rockville, Maryland (3 sites)
- Mayfield Heights, Ohio (2 sites)
Eligibility for these studies is generally broad, welcoming participants aged 4 to 99 years. All genders are invited to participate, and some studies specifically include healthy volunteers and children.
Development Timeline
The development journey for Deucravacitinib began on February 26, 2021, with the initiation of its first clinical trial. Since then, Bristol-Myers Squibb has been the primary sponsor, driving the majority of the research efforts. The latest trial is projected to conclude on May 4, 2026, indicating ongoing commitment to understanding this medication.
Initially, Deucravacitinib was explored for conditions such as IBS-C and hyperphosphatemia. However, the research pipeline quickly expanded, demonstrating a strategic shift towards dermatological and autoimmune disorders. Early studies included healthy participants, allowing for foundational understanding of the drug.
The development progressed through various phases, including early Phase 1, Phase 1, Phase 2, Phase 3, and Phase 4 studies, alongside numerous real-world observational studies. This comprehensive approach has led to the investigation of Deucravacitinib across a broad spectrum of conditions. The pipeline now encompasses a wide array of indications, including:
- Psoriasis (Plaque Psoriasis, Psoriasis Vulgaris, Genital Psoriasis, Nail Psoriasis, Palmoplantar Psoriasis)
- Psoriatic Arthritis (including Juvenile Psoriatic Arthritis)
- Inflammatory skin conditions like Atopic Dermatitis, Eczema, Hidradenitis Suppurativa, Pityriasis Rubra Pilaris, and Pyoderma Gangrenosum
- Autoimmune conditions such as Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies, Vitiligo, Generalized, and Alopecia Areata
- Rare genetic skin disorders like Epidermolysis Bullosa Simplex, Ichthyosis, and Inflammatory Congenital Ichthyoses
With a total of 53 trials and an enrollment of over 18,263 participants to date, the extensive research reflects the drug's potential across diverse medical needs.