NCT05044234

A Study to Assess Adverse Events and Disease Activity With Cedirogant (ABBV-157) in Adult Participants With Moderate to Severe Psoriasis

Brief summary

Psoriasis is a chronic disease characterized by marked inflammation and thickening of the skin that results in thick, scaly skin plaques. This study will assess how safe and effective cedirogant (ABBV-157) is compared to placebo in adult participants with moderate to severe psoriasis. Efficacy and safety-related measurements are assessing disease activity in participants with plaque psoriasis. Cedirogant (ABBV-157) is an investigational drug being developed for the treatment of chronic plaque psoriasis. Participants will be put into 1 of 4 groups, called treatment arms and each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to placebo. Approximately 200 adult participants with moderate to severe plaque psoriasis will be enrolled at approximately 45 sites. Participants will receive oral daily doses of cedirogant or placebo capsules for 16 weeks. There may be a higher burden for participants in this study compared to usual standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.

Interventional study

Status:
Recruiting
Conditions:
Psoriasis
Enrollment:
200 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M18-816
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

From 18 Years to 65 Years.

Inclusion Criteria:

- Participants with stable moderate to severe plaque psoriasis of at least 6 months
duration and who are candidates for systemic therapy or phototherapy.

Exclusion Criteria:

- Primary non-responders to previous anti-IL-17 (e.g., secukinumab, ixekizumab,
brodalumab), anti-IL-23 (e.g., guselkumab, tildrakizumab, risankizumab), or
anti-IL-12/23 (e.g., ustekinumab) treatment for chronic plaque psoriasis.

- Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis,
medication-induced or medication exacerbated psoriasis, or new onset guttate psoriasis
or any other skin disease which may interfere with assessment of chronic plaque
psoriasis.

All the cities where the clinical studies are located

Surrey - V3R 6A7
Barrie - L4M 7G1
London - N6H 5L5
Markham - L3P 1X2
Waterloo - N2J 1C4
Winnipeg - R3M 3Z4

British Columbia

Manitoba