PsoriasisPhase 3AMAGINE-1NCT01708590

Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects

A Phase 3 study testing 210 mg brodalumab and 140 mg brodalumab in people with Psoriasis, run by Bausch Health Americas, Inc. at 78 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to assess the safety and efficacy of brodalumab taken every two weeks at two different doses. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Psoriasis
What is being tested?: 210 mg brodalumab and 140 mg brodalumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 661 participants
Where: 78 sitesin 6 countries
Study dates: Aug 2012to Aug 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

78 sites in 6 countries.

Country

City, postcode or hospital

78 sites in 6 countries

United States33 sites

Research Site
Alpharetta, Georgia, 30022
Research Site
Arlington, Texas, 76011
Research Site
Austin, Texas, 78759
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Bakersfield, California, 93301
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Boston, Massachusetts, 02111
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Buffalo, New York, 14221
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Cleveland, Ohio, 44106
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Columbia, Maryland, 21045
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Dallas, Texas, 75231
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Encino, California, 91436
Research Site
Forest Hills, New York, 11375
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Fort Gratiot, Michigan, 48059
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Goodlettsville, Tennessee, 37072
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Houston, Texas, 77030
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Los Angeles, California, 90045
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Nashville, Tennessee, 37215
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Omaha, Nebraska, 68131
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Phoenix, Arizona, 85023
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Portland, Oregon, 97223
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Rapid City, South Dakota, 57702
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Richmond, Kentucky, 40475
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Rochester, New York, 14618
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San Antonio, Texas, 78229
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San Diego, California, 92123
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San Francisco, California, 94118
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San Ramon, California, 94583
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Santa Monica, California, 90404
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St Louis, Missouri, 63104
Research Site
St Louis, Missouri, 63117
Research Site
St Louis, Missouri, 63141
Research Site
Stony Brook, New York, 11790
Research Site
West Dundee, Illinois, 60118
Research Site
Wilmington, North Carolina, 28401

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Germany15 sites

Research Site
Berlin, 10117
Research Site
Berlin, 13507
Research Site
Blankenfelde, 15831
Research Site
Bochum, 44803
Research Site
Bonn, 53105
Research Site
Buchholz, 21244
Research Site
Dülmen, 48249
Research Site
Frankfurt am Main, 60590
Research Site
Friedrichshafen, 88045
Research Site
Halle, 06120
Research Site
Hamburg, 20246
Research Site
Hamburg, 20354
Research Site
Kiel, 24105
Research Site
Münster, 48149
Research Site
OsnabrÃ¼ck, 49074

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Poland11 sites

Research Site
Iwonicz-Zdrój, 38-440
Research Site
Lodz, 90-265
Research Site
Lodz, 90-436
Research Site
Olsztyn, 10-228
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Poznan, 60-539
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Szczecin, 70-111
Research Site
Torun, 87-100
Research Site
Warsaw, 01-192
Research Site
Wroclaw, 50-088
Research Site
Wroclaw, 50-368
Research Site
Wroclaw, 51-318

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Canada10 sites

Research Site
Greater Sudbury, Ontario, P3C 1X8
Research Site
Halifax, Nova Scotia, B3H 0A2
Research Site
London, Ontario, N6A 3H7
Research Site
Moncton, New Brunswick, E1C 8X3
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Montreal, Quebec, H2K 4L5
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North Bay, Ontario, P1B 3Z7
Research Site
Québec, Quebec, G1V 4X7
Research Site
Surrey, British Columbia, V3R 6A7
Research Site
Waterloo, Ontario, N2J 1C4
Research Site
Windsor, Ontario, N8W 1E6

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Switzerland5 sites

Research Site
Basel, 4031
Research Site
Bern, 3010
Research Site
Geneva, 1211
Research Site
Lausanne, 1011
Research Site
Zurich, 8091

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France4 sites

Research Site
Nice, 06200
Research Site
Pessac, 33604
Research Site
Saint-Priest-en-Jarez, 42270
Research Site
Toulouse, 31059

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About this study

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

The purpose of this study is to assess the safety and efficacy of brodalumab taken every two weeks at two different doses.

Read the detailed description

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.

Conditions: Psoriasis
Being tested: 210 mg brodalumab, 140 mg brodalumab, placebo
Keywords: psoriasis, brodalumab (AMG 827)
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

210 mg brodalumabDrug
Also called Siliq
210 mg brodalumab administered subcutaneous (SC)
140 mg brodalumabDrug
Also called Siliq
140 mg brodalumab administered subcutaneous (SC)
placeboDrug
Placebo administered subcutaneous (SC)

Study groups in NCT01708590
Study group	Role	What they receive
210 mg brodalumab	Experimental	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. Receives: Drug: 210 mg brodalumab; Drug: placebo
140 mg brodalumab	Experimental	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. Receives: Drug: 140 mg brodalumab; Drug: placebo
placebo	Placebo comparator	Administered by SC injection until week 12. At week 12 particpants are assigned to 210 mg brodalumab. Receives: Drug: 210 mg brodalumab; Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12
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.
Measured: 0-12 weeks
Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12
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
Measured: 0 - 12 Weeks

Secondary outcomes (1)

Percentage of Participants With Static Physicians Global Assessment (sPGA) Score Success (Score of 0 or 1) at 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.
Measured: Week 0 - Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2012Aug 2015

First posted17 Oct 2012 (estimated)
Study startAug 2012
Primary completionMay 2014
Study completionAug 2015

Why it stopped: Sponsor decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PsoriasisStudies of the same condition, open and under way.
More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 661 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01708590
Sponsor's protocol ID: 20120102
Other IDs: 2012-000651-13
Acronym: AMAGINE-1
Status last verified: Dec 2019
First submitted: 10 Sep 2012
Last updated: 3 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes

Publications

Gottlieb A, Lebwohl M, Liu C, Israel RJ, Jacobson A. Malignancy Rates in Brodalumab Clinical Studies for Psoriasis. Am J Clin Dermatol. 2020 Jun;21(3):421-430. doi: 10.1007/s40257-020-00512-4.
PubMed 32207067

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
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All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01708590
Acronym / sponsor ID: AMAGINE-1 / 20120102
Conditions: Psoriasis
Keywords: psoriasis, brodalumab (AMG 827)
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor decision
Enrolment: 661 participants (actual)
Lead sponsor: Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
Study start: Aug 2012
Primary completion: May 2014 (actual)
Study completion: Aug 2015 (actual)
First posted: 17 Oct 2012 (estimated)
Results: Posted 3 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to assess the safety and efficacy of brodalumab taken every two weeks at two different doses.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
210 mg brodalumab	Experimental	Drug: 210 mg brodalumab, Drug: placeboAdministered 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.
140 mg brodalumab	Experimental	Drug: 140 mg brodalumab, Drug: placeboAdministered 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.
placebo	Placebo comparator	Drug: 210 mg brodalumab, Drug: placeboAdministered by SC injection until week 12. At week 12 particpants are assigned to 210 mg brodalumab.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
210 mg brodalumabAlso: Siliq210 mg brodalumab administered subcutaneous (SC)	Drug	210 mg brodalumab, placebo
140 mg brodalumabAlso: Siliq140 mg brodalumab administered subcutaneous (SC)	Drug	140 mg brodalumab
placeboPlacebo administered subcutaneous (SC)	Drug	140 mg brodalumab, 210 mg brodalumab, placebo

Primary outcome

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

1 secondary outcome

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

Results and safety

Results posted to the registry on 3 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Induction Phase: 210 mg Brodalumab	222	212
Induction Phase: 140 mg Brodalumab	219	212
Induction Phase: Placebo	220	209
Withdrawal Phase: Placebo (140mg)	0	0
Withdrawal Phase: 140mg Brodalumab Q2W	0	0
Withdrawal Phase: Placebo (210mg)	0	0
Withdrawl Phase: 210mg Brodalumab Q2W	0	0

Primary outcome: Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12

Time frame: 0-12 weeks. Count of participants. Unit: Participants

Measure	Induction Phase: 210 mg Brodalumab n = 222	Induction Phase: 140 mg Brodalumab n = 219	Induction Phase: Placebo n = 220
Value	185	132	6

Population analysed: Data collected is based off of the data from the induction phase.

Primary outcome: Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12

Time frame: 0 - 12 Weeks. Count of participants. Unit: Participants

Measure	Induction Phase: 210 mg Brodalumab n = 222	Induction Phase: 140 mg Brodalumab n = 219	Induction Phase: Placebo n = 220
Value	168	118	3

Population analysed: Data reported is based off of the data collected from the induction phase

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
210 mg Brodalumab	4 of 222 (1.8%)	85 of 222 (38.3%)	Not reported
140 mg Brodalumab	6 of 219 (2.7%)	91 of 219 (41.6%)	Not reported
Placebo	3 of 220 (1.4%)	46 of 220 (20.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32207067Gottlieb A, Lebwohl M, Liu C, Israel RJ, Jacobson A. Malignancy Rates in Brodalumab Clinical Studies for Psoriasis. Am J Clin Dermatol. 2020 Jun;21(3):421-430. doi: 10.1007/s40257-020-00512-4.
AmgenTrials clinical trials websiteLink provided by the sponsor.
Individual participant dataSharing planned: Yes

Related trials for Psoriasis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
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Recruiting
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RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

78 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 210 mg brodalumab and 140 mg brodalumab in people with Psoriasis, run by Bausch Health Americas, Inc. at 78 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States, Germany, Poland, Canada, Switzerland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12 (time frame: 0-12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01708590, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.