Moderate to Severe Plaque PsoriasisPhase 3AMAGINE-2NCT01708603
P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis
A Phase 3 study testing 210 mg brodalumab, 140 mg brodalumab and ustekinumab in people with Moderate to Severe Plaque Psoriasis, run by Bausch Health Americas, Inc. at 153 sites in 11 countries.
Trial summary
The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Moderate to Severe Plaque Psoriasis
- What is being tested?
- 210 mg brodalumab, 140 mg brodalumab and ustekinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,831 participants
- Where
- 153 sitesin 11 countries
- Study dates
- Aug 2012to Oct 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 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 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
Trial locations and contacts
153 sites in 11 countries.
153 sites in 11 countries
United States67 sites
Research Site
Anderson, South Carolina, 29621
Research Site
Ann Arbor, Michigan, 48109
Research Site
Atlanta, Georgia, 30342
Research Site
Austin, Texas, 78759
Research Site
Aventura, Florida, 33180
Research Site
Bakersfield, California, 93309
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Beachwood, Ohio, 44122
Research Site
Beverly Hills, California, 90211
Research Site
Birmingham, Alabama, 35233
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Boston, Massachusetts, 02114
Research Site
Boston, Massachusetts, 02115
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Brooklyn, New York, 11209
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Carmel, Indiana, 46032
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Charlotte, North Carolina, 28210
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Chicago, Illinois, 60611
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Chicago, Illinois, 60654
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Columbus, Ohio, 43212
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Dallas, Texas, 75246
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Denver, Colorado, 80209
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Denver, Colorado, 80210
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Denver, Colorado, 80239
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Durham, North Carolina, 27710
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Fridley, Minnesota, 55432
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Gahanna, Ohio, 43230
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Henderson, Nevada, 89074
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Hot Springs, Arkansas, 71913
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Houston, Texas, 77065
Research Site
Irvine, California, 92697
Research Site
Jacksonville, Florida, 32216
Research Site
Lake Charles, Louisiana, 70601
Research Site
Lake Charles, Louisiana, 70605
Research Site
Los Angeles, California, 90027
Research Site
Los Angeles, California, 90045
Research Site
Louisville, Kentucky, 40202
Research Site
Miami, Florida, 33136
Research Site
Mt. Pleasant, South Carolina, 29464
Research Site
New Haven, Connecticut, 06511
Research Site
New Orleans, Louisiana, 70112
Research Site
New York, New York, 10029
Research Site
Newnan, Georgia, 30263
Research Site
Norfolk, Virginia, 23502
Research Site
North Andover, Massachusetts, 01845
Research Site
Omaha, Nebraska, 68144
Research Site
Pembroke Pines, Florida, 33028
Research Site
Pittsburgh, Pennsylvania, 15213
Research Site
Plainfield, Indiana, 46168
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Portland, Oregon, 97239
Research Site
Raleigh, North Carolina, 27612
Research Site
Roanoke, Virginia, 24016
Research Site
Rochester, New York, 14625
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Rockville, Maryland, 20850
Research Site
Sacramento, California, 95816
Research Site
San Antonio, Texas, 78229
Research Site
San Antonio, Texas, 78249
Research Site
San Diego, California, 92103
Research Site
San Diego, California, 92123
Research Site
Seattle, Washington, 98101
Research Site
Silver Spring, Maryland, 20902
Research Site
Skokie, Illinois, 60077
Research Site
Snellville, Georgia, 30078
Research Site
South Bend, Indiana, 46617
Research Site
South Euclid, Ohio, 44118
Research Site
Tampa, Florida, 33612
Research Site
Tucson, Arizona, 85710
Research Site
Vista, California, 92083
Research Site
West Jordan, Utah, 84088
Research Site
Winston-Salem, North Carolina, 27103
Canada14 sites
Research Site
Ajax, Ontario, L1S 7K8
Research Site
Calgary, Alberta, T3A 2N1
Research Site
Edmonton, Alberta, T5K 1X3
Research Site
Greater Sudbury, Ontario, P3E 1H5
Research Site
Mississauga, Ontario, L5H 1G9
Research Site
Montreal, Quebec, H3H 1V4
Research Site
Oakville, Ontario, L6J 7W5
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Ottawa, Ontario, K2G 6E2
Research Site
Peterborough, Ontario, K9J 1Z2
Research Site
Surrey, British Columbia, V3R 6A7
Research Site
Vancouver, British Columbia, V5Z 3Y1
Research Site
Waterloo, Ontario, N2J 1C4
Research Site
Windsor, Ontario, N8W 1E6
Research Site
Windsor, Ontario, N8W 5L7
Poland14 sites
Research Site
Gdynia, 81-384
Research Site
Katowice, 40-040
Research Site
Lodz, 90-265
Research Site
Lodz, 90-436
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Lublin, 20-080
Research Site
Szczecin, 70-332
Research Site
Tarnów, 33-100
Research Site
Warsaw, 02-106
Research Site
Warsaw, 04-141
Research Site
Wroclaw, 50-088
Research Site
Wroclaw, 50-368
Research Site
Wroclaw, 51-153
Research Site
Wroclaw, 51-318
Research Site
Wroclaw, 53-658
Spain13 sites
Research Site
A Coruña, Galicia, 15001
Research Site
Alcañiz, Aragón, 44600
Research Site
Alcorcón, Madrid, 28922
Research Site
Badalona, Cataluña, 08916
Research Site
Barcelona, Cataluña, 08003
Research Site
Barcelona, Cataluña, 08025
Research Site
Barcelona, Cataluña, 08036
Research Site
Barcelona, Cataluña, 08041
Research Site
Córdoba, AndalucÃ-a, 14004
Research Site
Madrid, 28006
Research Site
Manacor, Balearic Islands, 07500
Research Site
Seville, AndalucÃ-a, 41009
Research Site
Valencia, Valencia, 46014
France10 sites
Research Site
Amiens, 80504
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Besançon, 25030
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Brest, 29609
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Clermont-Ferrand, 63000
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Marseille, 13385
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Montpellier, 34295
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Paris, 75475
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Pessac, 33604
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Pierre-Bénite, 69495
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Rouen, 76031
Australia8 sites
Research Site
Benowa, Queensland, 4217
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Box Hill, Victoria, 3128
Research Site
Carlton, Victoria, 3053
Research Site
Gold Coast, Queensland, 4217
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Kogarah, New South Wales, 2217
Research Site
Parkville, Victoria, 3050
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Phillip, Australian Capital Territory, 2606
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Woolloongabba, Queensland, 4102
Czechia7 sites
Research Site
Brno, 656 91
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Jihlava, 586 33
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Nový Jičín, 741 01
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Prague, 100 34
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Prague, 150 06
Research Site
Prague, 180 81
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Ústí nad Labem, 401 13
Austria6 sites
Research Site
Graz, 8036
Research Site
Innsbruck, 6020
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Linz, 4020
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Vienna, 1030
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Vienna, 1090
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Vienna, 1130
Hungary6 sites
Research Site
Budapest, 1036
Research Site
Debrecen, 4012
Research Site
Kecskemét, 6000
Research Site
Miskolc, 3529
Research Site
Nyíregyháza, 4400
Research Site
Veszprém, 8200
Netherlands4 sites
Research Site
Amsterdam, 1105 AZ
Research Site
Breda, 4818 CK
Research Site
Nijmegen, 6525 GL
Research Site
Rotterdam, 3015 CA
Portugal4 sites
Research Site
Coimbra, 3000-075
Research Site
Lisbon, 1649-035
Research Site
Porto, 4050
Research Site
Porto, 4200-319
About this study
Official 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
The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses
Read the 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.
- Conditions
- Moderate to Severe Plaque Psoriasis
- Being tested
- 210 mg brodalumab, 140 mg brodalumab, ustekinumab, 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
210 mg brodalumab administered SC
140 mg brodalumabDrug
140 mg brodalumab administered SC
ustekinumabDrug
45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.
placeboDrug
Placebo administered SC
| 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 schedule 1, 2, 3, or 4. Receives: Drug: 210 mg brodalumab |
| 140 mg brodalumab | Experimental | Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4. Receives: Drug: 140 mg brodalumab |
| ustekinumab | Active comparator | Administered by subcutaneous (SC) injection per the labeled dosing regimen. Receives: Drug: ustekinumab |
| Placebo | Placebo comparator | Administered by subcutaneous (SC) injection until week 12. At week 12 participants 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 Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12
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).
Measured: 12 weeks
Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12
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.
Measured: 12 weeks
Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12
to evaluate the efficacy of Brodalumab (210mg Q2W) in clearing psoriasis as measured by the proportion of subjects achieving PASI 100 at week 12.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2012 (estimated)
- Study startAug 2012
- Primary completionSep 2014
- Study completionOct 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 (6)Papers the sponsor has linked to this study.
- Other trials for Moderate to Severe Plaque 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
- 1,831 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708603
- Sponsor's protocol ID
- 20120103
- Acronym
- AMAGINE-2
- Status last verified
- Jan 2020
- First submitted
- 12 Sep 2012
- Last updated
- 6 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Lebwohl MG, Armstrong AW, Alexis AF, Lain EL, Jacobson AA. Efficacy of Brodalumab in Patients with Psoriasis and Risk Factors for Treatment Failure: A Review of Post Hoc Analyses. Dermatol Ther (Heidelb). 2024 Oct;14(10):2709-2726. doi: 10.1007/s13555-024-01264-3. Epub 2024 Sep 12.
PubMed 39264399Kokolakis G, Vadstrup K, Hansen JB, Carrascosa JM. Increased Skin Clearance and Quality of Life Improvement with Brodalumab Compared with Ustekinumab in Psoriasis Patients with Aggravating Lifestyle Factors. Dermatol Ther (Heidelb). 2021 Dec;11(6):2027-2042. doi: 10.1007/s13555-021-00618-5. Epub 2021 Oct 2.
PubMed 34606048Gottlieb 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 32207067McMichael A, Desai SR, Qureshi A, Rastogi S, Alexis AF. Efficacy and Safety of Brodalumab in Patients with Moderate-to-Severe Plaque Psoriasis and Skin of Color: Results from the Pooled AMAGINE-2/-3 Randomized Trials. Am J Clin Dermatol. 2019 Apr;20(2):267-276. doi: 10.1007/s40257-018-0408-z.
PubMed 30471012Langley RG, Armstrong AW, Lebwohl MG, Blauvelt A, Hsu S, Tyring S, Rastogi S, Pillai R, Israel R. Efficacy and safety of brodalumab in patients with psoriasis who had inadequate responses to ustekinumab: subgroup analysis of two randomized phase III trials. Br J Dermatol. 2019 Feb;180(2):306-314. doi: 10.1111/bjd.17318. Epub 2018 Dec 27.
PubMed 30328108Lebwohl M, Strober B, Menter A, Gordon K, Weglowska J, Puig L, Papp K, Spelman L, Toth D, Kerdel F, Armstrong AW, Stingl G, Kimball AB, Bachelez H, Wu JJ, Crowley J, Langley RG, Blicharski T, Paul C, Lacour JP, Tyring S, Kircik L, Chimenti S, Callis Duffin K, Bagel J, Koo J, Aras G, Li J, Song W, Milmont CE, Shi Y, Erondu N, Klekotka P, Kotzin B, Nirula A. Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis. N Engl J Med. 2015 Oct;373(14):1318-28. doi: 10.1056/NEJMoa1503824.
PubMed 26422722
Study at a glance
From the registry record, last updated by the sponsor on 6 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 and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-2
- ClinicalTrials.gov ID
- NCT01708603
- Acronym / sponsor ID
- AMAGINE-2 / 20120103
- Conditions
- Moderate to Severe Plaque Psoriasis
- Keywords
- psoriasis, brodalumab, AMG 827
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 1,831 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 17 Oct 2012 (estimated)
- Results
- Posted 6 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 210 mg brodalumab | Experimental | Drug: 210 mg brodalumabAdministered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4. |
| 140 mg brodalumab | Experimental | Drug: 140 mg brodalumabAdministered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4. |
| ustekinumab | Active comparator | Drug: ustekinumabAdministered by subcutaneous (SC) injection per the labeled dosing regimen. |
| Placebo | Placebo comparator | Drug: 210 mg brodalumab, Drug: placeboAdministered by subcutaneous (SC) injection until week 12. At week 12 participants 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 (2 listed)
- 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
Key exclusion criteria (7 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 not stopped using certain psoriasis therapies as defined in the study protocol
- Subject has previously used ustekinumab or 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 brodalumab210 mg brodalumab administered SC | Drug | 210 mg brodalumab, Placebo |
| 140 mg brodalumab140 mg brodalumab administered SC | Drug | 140 mg brodalumab |
| ustekinumab45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen. | Drug | ustekinumab |
| placeboPlacebo administered SC | Drug | Placebo |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39264399Lebwohl MG, Armstrong AW, Alexis AF, Lain EL, Jacobson AA. Efficacy of Brodalumab in Patients with Psoriasis and Risk Factors for Treatment Failure: A Review of Post Hoc Analyses. Dermatol Ther (Heidelb). 2024 Oct;14(10):2709-2726. doi: 10.1007/s13555-024-01264-3. Epub 2024 Sep 12.
- Derived from this study: PubMed 34606048Kokolakis G, Vadstrup K, Hansen JB, Carrascosa JM. Increased Skin Clearance and Quality of Life Improvement with Brodalumab Compared with Ustekinumab in Psoriasis Patients with Aggravating Lifestyle Factors. Dermatol Ther (Heidelb). 2021 Dec;11(6):2027-2042. doi: 10.1007/s13555-021-00618-5. Epub 2021 Oct 2.
- 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.
- Derived from this study: PubMed 30471012McMichael A, Desai SR, Qureshi A, Rastogi S, Alexis AF. Efficacy and Safety of Brodalumab in Patients with Moderate-to-Severe Plaque Psoriasis and Skin of Color: Results from the Pooled AMAGINE-2/-3 Randomized Trials. Am J Clin Dermatol. 2019 Apr;20(2):267-276. doi: 10.1007/s40257-018-0408-z.
- Derived from this study: PubMed 30328108Langley RG, Armstrong AW, Lebwohl MG, Blauvelt A, Hsu S, Tyring S, Rastogi S, Pillai R, Israel R. Efficacy and safety of brodalumab in patients with psoriasis who had inadequate responses to ustekinumab: subgroup analysis of two randomized phase III trials. Br J Dermatol. 2019 Feb;180(2):306-314. doi: 10.1111/bjd.17318. Epub 2018 Dec 27.
- Derived from this study: PubMed 26422722Lebwohl M, Strober B, Menter A, Gordon K, Weglowska J, Puig L, Papp K, Spelman L, Toth D, Kerdel F, Armstrong AW, Stingl G, Kimball AB, Bachelez H, Wu JJ, Crowley J, Langley RG, Blicharski T, Paul C, Lacour JP, Tyring S, Kircik L, Chimenti S, Callis Duffin K, Bagel J, Koo J, Aras G, Li J, Song W, Milmont CE, Shi Y, Erondu N, Klekotka P, Kotzin B, Nirula A. Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis. N Engl J Med. 2015 Oct;373(14):1318-28. doi: 10.1056/NEJMoa1503824.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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
153 sites in 11 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, 140 mg brodalumab and ustekinumab in people with Moderate to Severe Plaque Psoriasis, run by Bausch Health Americas, Inc. at 153 sites in 11 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 2 inclusion and 7 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 6 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 153 sites in United States, Canada, Poland, Spain, France and 6 more countries. 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 6 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 Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 (time frame: 12 weeks). The study lists 3 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 NCT01708603, which also lists 6 linked publications.
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 6 Jan 2020.