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

AbbVie

Status and phase: Terminated; Phase 2

Conditions: Psoriasis

Treatments: Drug: Placebo; Drug: Cedirogant

Study type: Interventional

Funder types: Industry

Identifiers

NCT05044234

M18-816

Details and patient eligibility

About

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.

Enrollment: 156 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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156 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received placebo capsules for cedirogant orally once daily (QD) for 16 weeks.

Treatment:

Drug: Placebo

75 mg Cedirogant

Experimental group

Description:

Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks.

Treatment:

Drug: Cedirogant

150 mg Cedirogant

Experimental group

Description:

Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks.

Treatment:

Drug: Cedirogant

375 mg Cedirogant

Placebo Comparator group

Description:

Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks.

Treatment:

Drug: Cedirogant