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 assessed how safe and effective cedirogant (ABBV-157) was compared to placebo in adult participants with moderate to severe psoriasis. Efficacy and safety-related measurements assessed disease activity in participants with plaque psoriasis. Cedirogant (ABBV-157) is an investigational drug being developed for the treatment of chronic plaque psoriasis. Participants were put into 1 of 4 groups, called treatment arms and each group received a different treatment. There was a 1 in 4 chance that participants were assigned to placebo. Participants received oral daily doses of cedirogant or placebo capsules for 16 weeks. There may have been a higher burden for participants in this study compared to usual standard of care. Participants attended regular visits per routine clinical practice. The effect of the treatment was checked by medical assessments, checking for side effects, and questionnaires.

Interventional study

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

Would you like to know more about this trial?

alert image Please note, participation in the clinical trial is open to patients with the disease or condition under investigation.
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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-interleukin (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

British Columbia

Manitoba