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Study to Evaluate Broadlumab vs Placebo and Ustekinumab (AMAGINE-3)

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: NCT02786732
Recruitment Status : Terminated (Sponsor)
First Posted : June 1, 2016
Last Update Posted : June 1, 2016
Sponsor:
Information provided by (Responsible Party):
Michelle Pelle, M.D., MedDerm Associates

Brief Summary:
The purpose of the study is 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.

Condition or disease Intervention/treatment Phase
Psoriasis Biological: 210mg Brodalumab Biological: 140mg Brodalumab Biological: Ustekinumab Biological: Placebo Phase 3

Detailed Description:
The study is up to 5 years. If you qualify, you will be randomized into 1 of 4 groups. Two groups will get brodalumab(1 group will get 210milligrams of brodalumab at each dose and the other group will get 140 milligrams of brodalumab at each dose), one group will get ustekinumab, and one group will get placebo.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2012
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: 210mg Brodalumab
Administered by subcutaneous injection until Week 12
Biological: 210mg Brodalumab
Brodalumab 210mg administered subcutaneously

Experimental: 140mg Brodalumab
Administered subcutaneous injection until Week 12
Biological: 210mg Brodalumab
Brodalumab 210mg administered subcutaneously

Active Comparator: Ustekinumab
Administered subcutaneous injection until Week 52
Biological: 140mg Brodalumab
Brodalumab 140mg administered subcutaneously

Placebo Comparator: Placebo
Administered subcutaneous injection until Week 12
Biological: 210mg Brodalumab
Brodalumab 210mg administered subcutaneously

Biological: Ustekinumab
Ustekinumab 45mg or 90mg adminstered subcutaneously

Biological: Placebo
Placebo administered subcutaneously




Primary Outcome Measures :
  1. PASI Improvement [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject has had stable moderate to severe plaque psoriasis for at least 6 months before first dose of IP.
  • Subject has involved body surface area >_10%, PASI>_, and sPGA>_3 at screening and at baseline.
  • For women, a negative serum pregnancy test during screening a negative urine pregnancy test at baseline.
  • Subject has no known history of active tuberculosis.
  • Subject has a negative test for tuberculosis during screening.

Exclusion Criteria:

  • Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at the time of the screening visit that would interfere with evaluations of the effect of IP on psoriasis.
  • Subject has a planned surgical intervention between baseline and the week 52 evaluation.
  • Subject an active infection or history of infections.
  • Subject has any systemic disease considered by the investigator to be clinically significant and uncontrolled.
  • Subject has known history of Crohn's disease.
  • Subject has known history of hepatitis B, hepatitis C, or human immunodeficiency virus.
  • Subject had myocardial infarction or unstable angina pectoris within the past 12 months prior to the first dose of IP.
  • Subject has any active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma.
  • Subject has history of malignancy within 5 years EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma.
  • Subject has received live vaccine(s) within 28 days of the first dose of IP.
  • Subject has used ustekinumab and/or antio-IL-17 biologic therapy ever or other experimental or commercially available biologi immune modulator(s) within 12weeks prior to the first IP dose
  • Subject currently is enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s).
  • For women not willing to use highly effective methods of birth control during treatment and for 15 weeks after the last dose.
  • For women; pregnant or breast feeding, or planning to become pregnant while enrolled in the study and for 15 weeks after the last dose.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786732


Locations
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United States, California
MedDerm Associates
San Diego, California, United States, 92103
Sponsors and Collaborators
MedDerm Associates
Investigators
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Principal Investigator: Michelle T Pelle, M.D. MedDerm Associates
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Responsible Party: Michelle Pelle, M.D., Principal Investigator, MedDerm Associates
ClinicalTrials.gov Identifier: NCT02786732    
Other Study ID Numbers: 20120104
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Michelle Pelle, M.D., MedDerm Associates:
Psoriasis
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ustekinumab
Brodalumab
Antibodies, Monoclonal
Dermatologic Agents
Immunologic Factors
Physiological Effects of Drugs