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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: ABBVIE CALL CENTER
- Telefonnummer: 844-663-3742
- E-mail: abbvieclinicaltrials@abbvie.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Risankizumab and ABBV-295 Combination Therapy
Participants will receive risankizumab in combinations with ABBV-295 for up to 52 weeks. |
Injection Injection |
|
Aktiv komparator: Risankizumab and ABBV-295 Matching Placebo
Participants will receive risankizumab with ABBV-295 matching placebo for up to 52 weeks. |
Injection Injection |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants Achieving at least a 90% reduction from Baseline in Psoriasis Area and Severity Index (PASI 90)
Tidsramme: 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)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants Achieving 100% Reduction from Baseline in PASI 100
Tidsramme: 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
Tidsramme: Week 28
|
Achievement of at least 10% body weight reduction from Baseline. |
Week 28
|
|
Percent Change from Baseline in Body Weight
Tidsramme: Week 28
|
Percent change from Baseline in body weight. |
Week 28
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: ABBVIE INC., AbbVie
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- M26-507
- 2026-527347-17-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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-delingstidsramme
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
IPD-delingsadgangskriterier
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
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