A Study to Assess Targeted Therapies for Treatment of Adults With Moderate to Severe Psoriasis
A Phase 2 Multicenter Platform Trial of Targeted Therapies for Treatment of Adult Subjects With Moderate to Severe Psoriasis
Psoriasis is a long-term skin disease that causes inflammation, thick skin, and scaly patches on the skin. This study evaluates the safety and effectiveness of risankizumab in combination with ABBV-295 compared with risankizumab alone in adult participants with moderate to severe psoriasis.
Risankizumab is an approved drug for the treatment of moderate to severe psoriasis. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. Participants will receive either risankizumab plus ABBV-295 or risankizumab plus ABBV-295 matching placebo. Around 105 adult participants with moderate to severe psoriasis will be enrolled in the study at approximately 50 sites worldwide.
Participants will receive injections of risankizumab and ABBV-295 or risankizumab and ABBV-295 matching placebo for up to 52 weeks, with a 20-week follow-up period after the last dose of the study.
There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
연구 개요
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: ABBVIE CALL CENTER
- 전화번호: 844-663-3742
- 이메일: abbvieclinicaltrials@abbvie.com
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Clinical diagnosis of chronic plaque psoriasis (PsO) with or without psoriatic arthritis for at least 6 months before the Baseline Visit
- Stable moderate to severe chronic plaque psoriasis with or without Psoriatic arthritis (PsA) at both Screening and Baseline Visit defined as follows: ≥ 10% Body Surface Area psoriasis involvement, Static Physician's Global Assessment score of ≥ 3, and PASI score ≥ 12
- Candidates for systemic therapy or phototherapy as assessed by the investigator.
Exclusion Criteria:
- Participants with any form of PsO other than chronic plaque PsO (e.g., pustular PsO, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic, or guttate PsO).
- Participants with a history of current drug-induced PsO or a drug-induced exacerbation of pre-existing PsO.
- Participants with a history of active ongoing inflammatory skin diseases other than PsO (with or without PsA) that could interfere with the assessment of PsO (e.g., hyperkeratotic eczema).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Risankizumab and ABBV-295 Combination Therapy
Participants will receive risankizumab in combinations with ABBV-295 for up to 52 weeks. |
Injection Injection |
|
활성 비교기: Risankizumab and ABBV-295 Matching Placebo
Participants will receive risankizumab with ABBV-295 matching placebo for up to 52 weeks. |
Injection Injection |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants Achieving at least a 90% reduction from Baseline in Psoriasis Area and Severity Index (PASI 90)
기간: Week 28
|
PASI is a measure of psoriatic disease severity taking into account the overall severity of erythema, induration and scaling, and the extent of affected area in each of four anatomical regions (head, trunk, upper extremities, and lower extremities). PASI scores range from 0 (no psoriasis) to 72 (severe disease over the entire body surface). Higher scores indicate worse disease severity. PASI 90 indicates at least 90% improvement from baseline. |
Week 28
|
|
Number of Participants with Adverse Events (AEs)
기간: Up to 72 Weeks
|
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. |
Up to 72 Weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants Achieving 100% Reduction from Baseline in PASI 100
기간: Week 28
|
PASI is a measure of psoriatic disease severity taking into account the overall severity of erythema, induration and scaling, and the extent of affected area in each of four anatomical regions (head, trunk, upper extremities, and lower extremities). PASI scores range from 0 (no psoriasis) to 72 (severe disease over the entire body surface). Higher scores indicate worse disease severity. PASI 100 indicates at least 100% improvement from baseline. |
Week 28
|
|
Percentage of Participants Achieving ≥10% Body Weight Reduction from Baseline
기간: Week 28
|
Achievement of at least 10% body weight reduction from Baseline. |
Week 28
|
|
Percent Change from Baseline in Body Weight
기간: Week 28
|
Percent change from Baseline in body weight. |
Week 28
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: ABBVIE INC., AbbVie
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- M26-507
- 2026-527347-17-00 (씨티스)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
IPD 공유 기간
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
IPD 공유 액세스 기준
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
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