Risankizumab Long-term Remission Study

Part of paid clinical trials in Sacramento, California.

Sponsor
Jaehwan Kim
Study ID
NCT04630652
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Risankizumab-Rzaa — DRUG
    Risankizumab at a dose of 150 mg with injections administered at baseline, week 4 and week 16 following FDA-approved dosage and time periods
  • Punch biopsies of the skin at baseline visit — PROCEDURE
    Two 6 mm punch biopsies of the skin at baseline visit
  • Punch biopsies of the skin at week 28 visit — PROCEDURE
    One 6 mm punch biopsy of the skin at week 28 visit

Study Details

Although the newly developed biologics (drugs derived from living cells cultured in a laboratory) are highly effective in controlling psoriasis, all the biologics should be continuously injected to suppress recurrence of the disease. In this regard, the observation in the phase II clinical trial conducted by us (Laboratory for Investigative Dermatology at the Rockefeller University) was groundbreaking that just a single dose of anti-IL-23p19 antibody (risankizumab, trade name: Skyrizi, study drug in this clinical trial) administration produced disease clearance up to 66 weeks in 46% (6 of 13) of patients. However, there is a lack of understanding about immune regulation in human skin induced by anti-IL-23p19 antibody injection, and there is a need to conduct a psoriasis clinical trial for single-cell sequencing immune cells in human psoriasis skin before and after anti-IL-23p19 antibody administration, and to correlate regulatory immune cell alterations with clinical disease progression. The overall objective of the clinical trial is to study regulatory immune cell alterations induced by anti-IL-23p19 antibody administration in psoriasis patients who achieve long-term disease clearance off drugs.

Key Dates

Start date
Apr 7, 2021
Status verified
May 2026
Primary completion
May 13, 2025
Completion
May 13, 2025

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Psoriasis treatment with risankizumab
    Moderate-to-severe psoriasis treatment with risankizumab for 16 weeks

Primary Outcome Measure

Determination of regulatory immune cell changes induced by risankizumab [ Time Frame: week 52 ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of California Davis Medical CenterSacramentoCalifornia95817-
VA Northern California Health Care SystemSacramentoCalifornia95655-
The Rockefeller UnivesityNew YorkNew York10065-

Find similar trials in Sacramento, CA

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
University of California Davis Medical Center· Sacramento, CAVA Northern California Health Care System· Sacramento, CAThe Rockefeller Univesity· New York, NY

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