Skyrizi for Psoriasis

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byJaehwan Kim, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Jaehwan Kim

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults with plaque psoriasis for at least 6 months, a PASI score over 12, and more than 10% body surface area affected. Participants must not use other psoriasis treatments or live vaccines during the trial and cannot be pregnant.

Inclusion Criteria

Over 10% of my body is covered by plaque psoriasis.

I have been diagnosed with plaque psoriasis for at least 6 months.

Your Psoriasis Area Severity Index (PASI) score is higher than 12 before starting the trial.

+6 more

Exclusion Criteria

Any investigational study medication within previous 6 months prior to visit 0

I haven't taken immunosuppressive drugs in the last 4 weeks.

I currently have or recently had a serious infection that is not under control.

+9 more

Participant Groups

The study tests Risankizumab's ability to maintain long-term remission in psoriasis patients. It involves comparing skin biopsies before and after treatment to understand immune changes correlating with disease progression.

1Treatment groups

Experimental Treatment

Group I: Psoriasis treatment with risankizumabExperimental Treatment3 Interventions

Moderate-to-severe psoriasis treatment with risankizumab for 16 weeks