Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects (AMAGINE-1)
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| ClinicalTrials.gov Identifier: NCT01708590 |
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Recruitment Status :
Terminated
(Sponsor decision)
First Posted : October 17, 2012
Results First Posted : January 3, 2020
Last Update Posted : January 3, 2020
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Sponsor:
Bausch Health Americas, Inc.
Information provided by (Responsible Party):
Bausch Health Americas, Inc.
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Brief Summary:
The purpose of this study is to assess the safety and efficacy of brodalumab taken every two weeks at two different doses.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Psoriasis | Drug: 210 mg brodalumab Drug: 140 mg brodalumab Drug: placebo | Phase 3 |
The purpose of this study is to assess the safety and efficacy of brodalumab taken every two weeks at two different doses in participants with moderate to severe plaque psoriasis. A second purpose of this study is to assess the safety and efficacy when brodalumab is replaced with placebo in some participants compared with the participants who are still receiving the brodalumab.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 661 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3 Study to Evaluate the Efficacy, Safety, and Effect of Withdrawal and Retreatment With Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-1 |
| Study Start Date : | August 2012 |
| Actual Primary Completion Date : | May 2014 |
| Actual Study Completion Date : | August 2015 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Psoriasis
Drug Information
available for:
Brodalumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: 210 mg brodalumab
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease.
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Drug: 210 mg brodalumab
210 mg brodalumab administered subcutaneous (SC)
Other Name: Siliq Drug: placebo Placebo administered subcutaneous (SC) |
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Experimental: 140 mg brodalumab
Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to placebo or continued treatment. Participants are retreated at return of disease.
|
Drug: 140 mg brodalumab
140 mg brodalumab administered subcutaneous (SC)
Other Name: Siliq Drug: placebo Placebo administered subcutaneous (SC) |
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Placebo Comparator: placebo
Administered by SC injection until week 12. At week 12 particpants are assigned to 210 mg brodalumab.
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Drug: 210 mg brodalumab
210 mg brodalumab administered subcutaneous (SC)
Other Name: Siliq Drug: placebo Placebo administered subcutaneous (SC) |
Primary Outcome Measures :
- Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12 [ Time Frame: 0-12 weeks ]to evaluate the efficacy of brodalumab (210mg Q2W, 140mg Q2W) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects who achieved 75% improvement in Psoriasis Area Severity Index (PASI75) at week 12.
- Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 [ Time Frame: 0 - 12 Weeks ]To evaluate the efficacy of brodalumab (210mg Q2W, 140mg Q2W) in subjects with moderate to severe plaque psoriasis , as measured by the proportion of subjects who achieved success (clear [0] or almost clear [1]) on the static physicians global assessment (sPGA) at week 12
Secondary Outcome Measures :
- Percentage of Participants With Static Physicians Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 52 [ Time Frame: Week 0 - Week 52 ]to evaluate maintenance of effect with continued brodalumab treatment (210mg Q2W, 140mg Q2W) as measured by the proportion of subjects achieving success (clear[0] or almost clear [1]) at week 52.
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject has had stable moderate to severe plaque psoriasis for at least 6 months
- Subject must be considered, in the opinion of the investigator, to be a suitable candidate for treatment with a biologic per regional labeling
- 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 stopped using certain psoriasis therapies as defined in the study protocol
- Subject has previously used any anti-IL-17 biologic therapy
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): NCT01708590
Locations
Show 78 study locations
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
| Study Director: | MD | Amgen |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bausch Health Americas, Inc. |
| ClinicalTrials.gov Identifier: | NCT01708590 |
| Other Study ID Numbers: |
20120102 2012-000651-13 ( EudraCT Number ) |
| First Posted: | October 17, 2012 Key Record Dates |
| Results First Posted: | January 3, 2020 |
| Last Update Posted: | January 3, 2020 |
| Last Verified: | December 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
Keywords provided by Bausch Health Americas, Inc.:
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psoriasis, brodalumab (AMG 827) |
Additional relevant MeSH terms:
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Psoriasis Skin Diseases, Papulosquamous Skin Diseases Brodalumab |
Antibodies, Monoclonal Dermatologic Agents Immunologic Factors Physiological Effects of Drugs |