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P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis (AMAGINE-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01708603
Recruitment Status : Terminated (Sponsor decision)
First Posted : October 17, 2012
Results First Posted : January 6, 2020
Last Update Posted : January 6, 2020
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Tracking Information
First Submitted Date  ICMJE September 12, 2012
First Posted Date  ICMJE October 17, 2012
Results First Submitted Date  ICMJE October 31, 2016
Results First Posted Date  ICMJE January 6, 2020
Last Update Posted Date January 6, 2020
Study Start Date  ICMJE August 2012
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2020)
  • Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 [ Time Frame: 12 weeks ]
    Measures the physician's impression of the disease at a single point, and a dynamic form in which the physician assesses the global improvement from baseline. Success is defined by a score of 0 or 1 (clear to almost clear).
  • Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 [ Time Frame: 12 weeks ]
    to evaluate the efficacy of Brodalumab (210mg every 2 weeks, and 140mg every 2 weeks) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75 at week 12.
  • Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12 [ Time Frame: 12 Weeks ]
    to evaluate the efficacy of Brodalumab (210mg Q2W) in clearing psoriasis as measured by the proportion of subjects achieving PASI 100 at week 12.
Original Primary Outcome Measures  ICMJE
 (submitted: October 15, 2012)
  • Improvement in Psoriasis Area and Severity Index (PASI) [ Time Frame: 12 Weeks ]
    Efficacy of brodalumab in subjects with moderate to severe plaque psoriasis
  • Static Physician Global Assessment (sPGA) score [ Time Frame: 12 weeks ]
    Efficacy of brodalumab in subjects with moderate to severe plaque psoriasis
Change History Complete list of historical versions of study NCT01708603 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2012)
  • Improvement in Psoriasis Area and Severity Index (PASI) [ Time Frame: 12 weeks ]
    Efficacy of brodalumab in subjects with moderate to severe plaque psoriasis
  • Static Physician Global Assessment [ Time Frame: 12 weeks and 52 weeks ]
    Efficacy of brodalumab in subjects with moderate to severe plaque psoriasis
  • Patient reported outcomes symptom score [ Time Frame: 12 weeks ]
    Subject-reported outcomes assessment
  • Subject incidence of adverse events [ Time Frame: 12 weeks and 5 years ]
    Safety profile of brodalumab
  • Subject incidence of adverse events of interest [ Time Frame: 12 weeks and 5 years ]
    Safety profile of brodalumab
  • Presence of anti-brodalumab antibodies [ Time Frame: 12 weeks and 5 years ]
    Safety profile of brodalumab
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis
Official Title  ICMJE 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
Brief Summary The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses
Detailed Description .The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis. A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis. A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Moderate to Severe Plaque Psoriasis
Intervention  ICMJE
  • Drug: 210 mg brodalumab
    210 mg brodalumab administered SC
  • Drug: 140 mg brodalumab
    140 mg brodalumab administered SC
  • Drug: ustekinumab
    45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.
  • Drug: placebo
    Placebo administered SC
Study Arms  ICMJE
  • Experimental: 210 mg brodalumab
    Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
    Intervention: Drug: 210 mg brodalumab
  • Experimental: 140 mg brodalumab
    Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.
    Intervention: Drug: 140 mg brodalumab
  • Active Comparator: ustekinumab
    Administered by subcutaneous (SC) injection per the labeled dosing regimen.
    Intervention: Drug: ustekinumab
  • Placebo Comparator: Placebo
    Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.
    Interventions:
    • Drug: 210 mg brodalumab
    • Drug: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 26, 2014)
1831
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2012)
1800
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Canada,   Czechia,   France,   Hungary,   Netherlands,   Poland,   Portugal,   Spain,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01708603
Other Study ID Numbers  ICMJE 20120103
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Bausch Health Americas, Inc.
Study Sponsor  ICMJE Bausch Health Americas, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Bausch Health Americas, Inc.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP