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Placebo

Subcutaneous Risankizumab for Psoriasis (UnlIMMited Trial)

Verified Trial
Phase 4
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have a current diagnosis of moderate to severe genital psoriasis (Study-G) defined as static Physician Global Assessment of Genitalia (sPGA-G) ≥ 3 or moderate to severe scalp psoriasis (Study-S) defined as Psoriasis Scalp Severity Index (PSSI) ≥ 12, scalp Investigator Global Assessment (IGA) ≥ 3, and ≥ 30% of the scalp affected.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16
Awards & highlights

UnlIMMited Trial Summary

This trial is studying a new drug, risankizumab (Skyrizi), to treat moderate to severe genital and scalp psoriasis. 200 participants will receive injections of the drug for 1 year to assess safety & effectiveness.

Who is the study for?
Adults with a 6-month history of chronic plaque psoriasis, including those with psoriatic arthritis, can join. They must have moderate to severe genital or scalp psoriasis that hasn't responded well to other treatments and are candidates for systemic therapy or phototherapy.Check my eligibility
What is being tested?
The trial is testing Risankizumab's safety and effectiveness against placebo in adults with genital or scalp psoriasis. Participants will receive subcutaneous injections over a period of up to 52 weeks, followed by an 8-week follow-up.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, increased risk of infections due to immune system suppression, headaches, fatigue, and potential allergic reactions.

UnlIMMited Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have moderate to severe genital or scalp psoriasis.

UnlIMMited Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Study-G: Percentage of Participants with Achievement of static Physician Global Assessment of Genitalia (sPGA-G) of 0 or 1
Study-S: Percentage of Participants with Achievement of Scalp Investigator Global Assessment (IGA) of 0 or 1
Secondary outcome measures
Study-G: Percentage of Participants with Achievement of Clinically Meaningful (>= 4-point) Improvement from Baseline on the Genital Psoriasis Itch Numerical Rating Scale (NRS) [Among Participants with a Baseline Score >= 4]
Study-G: Percentage of Participants with Achievement of Dermatology Life Quality Index (DLQI) of 0 or 1
Study-G: Percentage of Participants with Achievement of Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 score of 0 or 1 Among Participants with a Baseline score >= 2
+6 more

UnlIMMited Trial Design

4Treatment groups
Experimental Treatment
Group I: Study S RisankizumabExperimental Treatment1 Intervention
Participants with moderate to severe scalp psoriasis will receive risankizumab during the 52 week treatment period, with an 8-week follow-up period after the 52 week treatment period.
Group II: Study S Placebo for RisankizumabExperimental Treatment2 Interventions
Participants with moderate to severe scalp psoriasis will receive placebo for risankizumab during the16 week treatment period followed by risankizumab during the 36 week treatment period, with an 8-week follow-up period after the 52 week treatment period.
Group III: Study G RisankizumabExperimental Treatment1 Intervention
Participants with moderate to severe genital psoriasis will receive risankizumab during the 52 week treatment period, with an 8-week follow-up period after the 52 week treatment period.
Group IV: Study G Placebo for RisankizumabExperimental Treatment2 Interventions
Participants with moderate to severe genital psoriasis will receive placebo for risankizumab during the 16 week treatment period followed by risankizumab during the 36 week treatment period, with an 8-week follow-up period after the 52 week treatment period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Risankizumab
2021
Completed Phase 3
~3140
Placebo for Risankizumab
2021
Completed Phase 3
~180

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
958 Previous Clinical Trials
502,190 Total Patients Enrolled
62 Trials studying Psoriasis
125,412 Patients Enrolled for Psoriasis
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
146,909 Total Patients Enrolled
22 Trials studying Psoriasis
17,863 Patients Enrolled for Psoriasis

Media Library

Placebo for Risankizumab (Placebo) Clinical Trial Eligibility Overview. Trial Name: NCT05969223 — Phase 4
Psoriasis Research Study Groups: Study G Risankizumab, Study S Placebo for Risankizumab, Study S Risankizumab, Study G Placebo for Risankizumab
Psoriasis Clinical Trial 2023: Placebo for Risankizumab Highlights & Side Effects. Trial Name: NCT05969223 — Phase 4
Placebo for Risankizumab (Placebo) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05969223 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA approved the use of Risankizumab as part of Study G?

"There is abundant evidence indicating the safety of Study G Risankizumab, thus it attained a score of 3. This trial is classified as Phase 4, signifying that this medication has received regulatory approval."

Answered by AI

For what size of a cohort is this experiment recruiting?

"Indeed, the information on clinicaltrials.gov affirms that this research is presently engaging participants. This trial was first posted on August 9th 2023 and has been recently modified as of October 11th 2023. Currently it is enrolling 200 patients at 1 medical facility."

Answered by AI

Are there remaining vacancies for participants of this experiment?

"Affirmative. According to data posted on clinicaltrials.gov, this medical trial is presently accepting participants; it was first published on August 9th 2023 and its most recent revision occurred two days later. The study requires 200 patients from a single site for full completion."

Answered by AI

What objectives are researchers trying to attain with this experiment?

"This trial aims to measure the percentage of participants with an Investigator Global Assessment (IGA) score of 0 or 1 at Week 16. Secondary objectives involve measuring participant quality-of-life through Dermatology Life Quality Index (DLQI), gauging itch intensity on a numerical rating scale, and capturing sexual frequency data via Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ)."

Answered by AI

Who else is applying?

What site did they apply to?
Dermatology Research Associates /ID# 255347
Forest Hills Dermatology Group /ID# 255346
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Study to Assess the Safety and Efficacy of Subcutaneously Injected Risankizumab in Adult Participants With Genital or Scalp Psoriasis
2023. "Study to Assess the Safety and Efficacy of Subcutaneously Injected Risankizumab in Adult Participants With Genital or Scalp Psoriasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05969223.
All > Psoriasis > Meridian
~62 spots leftby Sep 2024
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