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A Study to Assess Targeted Therapies for Treatment of Adults With Moderate to Severe Psoriasis

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Forrás: NCT07933536: ki vehet részt

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Contact the study team: see the registry record → Contacts and Locations

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AbbVie
Azonosító
NCT07933536EU 2026-527347-17-00
A regiszteradat frissítve
2026. november 12.
Eredeti leírás
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.A teljes eredeti leírásKevesebb

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.

Bevonási feltételek: 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.

Kizáró feltételek: 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); Participants with any form of PsO other than chronic plaque PsO (e.g., pustular PsO, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic, or guttate PsO).

ClinicalTrials.gov NCT07933536 · EU CTIS 2026-527347-17-00