P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01708603
• Date of registration: 12/09/2012
• Prospective Registration: No
• Primary sponsor: Bausch Health Americas, Inc.
• Public title: P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis AMAGINE-2
• Scientific title: A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-2
• Date of first enrolment: August 2012
• Target sample size: 1831
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01708603
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Canada, Czech Republic, Czechia, France, Hungary, Netherlands, Poland, Portugal, Spain, United States

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subject has had stable moderate to severe plaque psoriasis for at least 6 months

- Subject has involved body surface area (BSA) = 10%, PASI = 12, and sPGA = 3 at
screening and at baseline

Exclusion Criteria:

- Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis,
medication-induced psoriasis, or other skin conditions at (eg, eczema) that would
interfere with study evaluations

- Subject has known history of Crohn's disease

- Subject has any other significant concurrent medical condition or laboratory
abnormalities, as defined in the study protocol

- Subject has not stopped using certain psoriasis therapies as defined in the study
protocol

- Subject has previously used ustekinumab or any anti-IL-17 biologic therapy

- Subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in
the study

- Female subject is unwilling to use highly effective methods of birth control unless 2
years post-menopausal or surgically sterile



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Moderate to Severe Plaque Psoriasis

Intervention(s)

Drug: 140 mg brodalumab

Drug: ustekinumab

Drug: placebo

Drug: 210 mg brodalumab

Primary Outcome(s)

Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 [Time Frame: 12 weeks]

Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 [Time Frame: 12 weeks]

Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12 [Time Frame: 12 Weeks]

Secondary ID(s)

20120103

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/01/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01708603