Placebo

Study G Risankizumab for Psoriasis

Darst Dermatology /ID# 255848, Charlotte, NC

Targeting 2 different conditionsRisankizumab +1 morePhase 4RecruitingResearch Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upweek 16

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Study 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.

Eligible Conditions

Psoriasis
Scalp Psoriasis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 16

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

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~3150

Placebo for Risankizumab

2021

Completed Phase 3

~180

Do I qualify?Apply below to find out

Find a site

Who is running the clinical trial?

AbbVieLead Sponsor

893 Previous Clinical Trials

482,908 Total Patients Enrolled

60 Trials studying Psoriasis

124,846 Patients Enrolled for Psoriasis

ABBVIE INC.Study Director

AbbVie

340 Previous Clinical Trials

127,688 Total Patients Enrolled

20 Trials studying Psoriasis

17,297 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 G Placebo for Risankizumab, Study S Risankizumab, Study S 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

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.