AGN-242428 in the Treatment of Plaque Psoriasis

Vitae Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Plaque Psoriasis

Treatments: Drug: Placebo; Drug: AGN-242428

Study type: Interventional

Funder types: Industry

Identifiers

NCT03339999

1957-201-001

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of 3 doses of AGN-242428 in adult participants with moderate to severe plaque-type psoriasis.

Enrollment: 24 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who have a confirmed diagnosis of plaque psoriasis, diagnosed at least 6 months before study with a Physician's Global Assessment (PGA) score ≥ 3 at screening and baseline
• Severity of disease must be at least moderate, defined as Psoriasis Area and Severity Index (PASI) ≥ 12 and % body surface area (BSA) ≥ 10
• Participant is a candidate for phototherapy or systemic therapy for psoriasis
• Body weight of at least 55 kilograms (kg) (121 (pound) lbs)

Exclusion criteria

• Non-plaque forms of psoriasis (erythrodermic, guttate, pustular) or drug-induced psoriasis
• Psoriasis which has not been stable for the 4 weeks prior to screening and which is unstable at Study Day 1
• History of Gilbert's, Rotor, or Dubin-Johnson syndromes or any other disorder of bilirubin metabolism
• History of active mycobacterium tuberculosis (TB) infection or untreated or inadequately treated latent TB
• Positive QuantiFERON test for TB infection at screening
• Had a vaccination with Bacillus Calmette-Guérin (BCG) within 12 months prior to baseline
• Positive drug and/or alcohol test at screening (with the exception of marijuana). Retesting in the case of a positive alcohol test is allowed at the discretion of the sponsor
• Current treatment or history of treatment with any anti-Tumor Necrosis Factor alpha (TNFα) biologic therapy within 3 months or 5 half-lives of study, and/or all other biologics within 6 months of study (Day 1)
• Efficacy failure on 2 or more biologic agents for the treatment of psoriasis when the failures occurred within 1 year of the initiation of the therapy of the first biologic agent
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin (TBL) exceeding 1.5 times the upper limit of normal (ULN) at screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo-matching AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.

Treatment:

Drug: Placebo

AGN-242428 Higher Dose

Experimental group

Description:

AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.

Treatment:

Drug: AGN-242428

AGN-242428 Medium Dose

Experimental group

Description:

AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.

Treatment:

Drug: AGN-242428

AGN-242428 Lower Dose

Experimental group

Description:

AGN-242428 capsule and placebo-matching AGN-242428 capsule, oral administration, once-daily for up to 12 weeks.

Treatment:

Drug: AGN-242428

Drug: Placebo