Plaque PsoriasisPhase 3AMAGINE-3NCT01708629
Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects
A Phase 3 study testing 210 mg brodalumab, 140 mg brodalumab and ustekinumab in people with Plaque Psoriasis, run by Bausch Health Americas, Inc. at 157 sites in 11 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- 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
- 1,881 participants
- Where
- 157 sitesin 11 countries
- Study dates
- Sep 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
157 sites in 11 countries.
157 sites in 11 countries
United States74 sites
Research Site
Alpharetta, Georgia, 30022
Research Site
Ann Arbor, Michigan, 48103
Research Site
Arlington Heights, Illinois, 60005
Research Site
Atlanta, Georgia, 30327
Research Site
Bartlett, Tennessee, 38134
Research Site
Bellaire, Texas, 77401
Research Site
Beverly Hills, California, 90212
Research Site
Birmingham, Alabama, 35205
Research Site
Boca Raton, Florida, 33486
Research Site
Boise, Idaho, 83704
Research Site
Burbank, California, 91505
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Champaign, Illinois, 61820
Research Site
Cincinnati, Ohio, 45249
Research Site
Clarksburg, West Virginia, 26301
Research Site
Clarkston, Michigan, 48346
Research Site
Cleveland, Ohio, 44106
Research Site
Clinton Township, Michigan, 48038
Research Site
Coral Gables, Florida, 33134
Research Site
Dallas, Texas, 75230
Research Site
Dallas, Texas, 75231
Research Site
Denver, Colorado, 80220
Research Site
East Windsor, New Jersey, 08520
Research Site
Encino, California, 91436
Research Site
Exton, Pennsylvania, 19341
Research Site
Farmington, Connecticut, 06030
Research Site
Fremont, California, 94538
Research Site
Fullerton, California, 92835
Research Site
Greer, South Carolina, 29650
Research Site
Henderson, Nevada, 89074
Research Site
High Point, North Carolina, 27262
Research Site
Hoboken, New Jersey, 07030
Research Site
Hollywood, Florida, 33021
Research Site
Houston, Texas, 77004
Research Site
Houston, Texas, 77030
Research Site
Houston, Texas, 77082
Research Site
Indianapolis, Indiana, 46256
Research Site
Irvine, California, 92614
Research Site
Jacksonville, Florida, 32204
Research Site
Johnston, Rhode Island, 02919
Research Site
Lake Oswego, Oregon, 97035
Research Site
Las Vegas, Nevada, 89144
Research Site
Los Angeles, California, 90036
Research Site
Louisville, Kentucky, 40217
Research Site
Macon, Georgia, 31217
Research Site
Maywood, Illinois, 60153
Research Site
Miami, Florida, 33144
Research Site
Mobile, Alabama, 36608
Research Site
Nashville, Tennessee, 37205
Research Site
New Albany, Indiana, 47150
Research Site
New York, New York, 10016
Research Site
Norfolk, Virginia, 23507
Research Site
Normal, Illinois, 61761
Research Site
Ocala, Florida, 34471
Research Site
Overland Park, Kansas, 66202
Research Site
Overland Park, Kansas, 66215
Research Site
Owensboro, Kentucky, 42303
Research Site
Phoenix, Arizona, 85023
Research Site
Portland, Oregon, 97210
Research Site
Richmond, Virginia, 23294
Research Site
Riverside, California, 92505
Research Site
Rochester, New York, 14623
Research Site
Sacramento, California, 95819
Research Site
Salt Lake City, Utah, 84132
Research Site
San Diego, California, 92103
Research Site
San Diego, California, 92123
Research Site
San Francisco, California, 94118
Research Site
Spokane, Washington, 99204
Research Site
Tamarac, Florida, 33321
Research Site
The Bronx, New York, 10467
Research Site
Trumbull, Connecticut, 06611
Research Site
Verona, New Jersey, 07044
Research Site
Webster, Texas, 77598
Research Site
Wheaton, Illinois, 60189
Research Site
Worcester, Massachusetts, 01605
Canada17 sites
Research Site
Barrie, Ontario, L4M 6L2
Research Site
Calgary, Alberta, T2G 1B1
Research Site
Drummondville, Quebec, J2B 5L4
Research Site
Halifax, Nova Scotia, B3H 0A2
Research Site
Hamilton, Ontario, L8N 1V6
Research Site
Markham, Ontario, L3P 1A8
Research Site
Montreal, Quebec, H3Z 2S6
Research Site
Richmond Hill, Ontario, L4B 1A5
Research Site
Saint-Hyacinthe, Quebec, J2S 6L6
Research Site
St. John's, Newfoundland and Labrador, A1A 4Y3
Research Site
St. John's, Newfoundland and Labrador, A1A 5E8
Research Site
Toronto, Ontario, M3H 5Y8
Research Site
Toronto, Ontario, M5S 3B4
Research Site
Toronto, Ontario, M8X 1Y9
Research Site
Vancouver, British Columbia, V5Z 4E8
Research Site
Winnipeg, Manitoba, R3C 0N2
Research Site
Winnipeg, Manitoba, R3C 1R4
Poland14 sites
Research Site
Bialystok, 15-879
Research Site
Dąbrówka, 62-069
Research Site
Gdansk, 80-952
Research Site
Iwonicz-Zdrój, 38-440
Research Site
Katowice, 40-954
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Krakow, 30-510
Research Site
Krakow, 31-501
Research Site
Lodz, 90-242
Research Site
Lublin, 20-406
Research Site
Poznan, 60-539
Research Site
Stalowa Wola, 37-450
Research Site
Świdnik, 21-040
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Warsaw, 01-192
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Warsaw, 02-201
Australia8 sites
Research Site
Camperdown, New South Wales, 2050
Research Site
Darlinghurst, New South Wales, 2010
Research Site
Fremantle, Western Australia, 6160
Research Site
Hectorville, South Australia, 5073
Research Site
Kogarah, New South Wales, 2217
Research Site
St Leonards, New South Wales, 2065
Research Site
Sydney, New South Wales, 2000
Research Site
Westmead, New South Wales, 2145
Belgium7 sites
Research Site
Bruges, 8000
Research Site
Brussels, 1200
Research Site
Edegem, 2650
Research Site
Ghent, 9000
Research Site
Leuven, 3000
Research Site
Liège, 4000
Research Site
Montigny-le-Tilleul, 6110
France7 sites
Research Site
Créteil, 94010
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Limoges, 87000
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Nice, 06200
Research Site
Poitiers, 86000
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Saint-Priest-en-Jarez, 42270
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Toulouse, 31059
Research Site
Vandœuvre-lès-Nancy, 54511
Greece7 sites
Research Site
Athens, 16121
Research Site
Chaïdári, Athens, 12462
Research Site
Ioannina, 45500
Research Site
Larissa, 41110
Research Site
Marousi, 15123
Research Site
Thessaloniki, 54643
Research Site
Thessaloniki, 56429
Russia7 sites
Research Site
Moscow, 107076
Research Site
Moscow, 119991
Research Site
Moscow, 121614
Research Site
Saint Petersburg, 191015
Research Site
Saint Petersburg, 194044
Research Site
Saratov, 410026
Research Site
Yekaterinburg, 620076
Hungary6 sites
Research Site
Békéscsaba, 5600
Research Site
Budapest, 1085
Research Site
Gyula, 5700
Research Site
Szeged, 6720
Research Site
Szolnok, 5000
Research Site
Szombathely, 9700
Italy6 sites
Research Site
Bologna, 40138
Research Site
Genova, 16132
Research Site
Milan, 20122
Research Site
Milan, 48018
Research Site
Roma, 00133
Research Site
Roma, 00168
Latvia4 sites
Research Site
Riga, 1001
Research Site
Riga, 1003
Research Site
Riga, LV-1013
Research Site
Ventspils, 3601
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-3
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.
Read the detailed description
This study 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
- 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
Also called Siliq
210 mg brodalumab administered SC
140 mg brodalumabDrug
Also called Siliq
140 mg brodalumab administered SC
ustekinumabDrug
Also called Stelara
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 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 Psoriasis Area Severity Index (PASI) 75 at Week 12
The Psoriasis Area and Severity Index Score is used as a scale to show change from Baseline of study to a certain point. PASI Score ranges from (0) no disease to (72) maximal disease. The proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75, was assessed.
Measured: 12 weeks
Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo
Static Physician Global Assessment (sPGA) measures the physician's impression of the disease. Possible scores are (0 [clear] to 5 [severe]). Success was defined by a score of 0 or 1 (clear to almost clear).
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 startSep 2012
- Primary completionAug 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 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
- 1,881 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
- NCT01708629
- Sponsor's protocol ID
- 20120104
- Acronym
- AMAGINE-3
- Status last verified
- Dec 2019
- First submitted
- 21 Sep 2012
- Last updated
- 3 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 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 and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-3
- ClinicalTrials.gov ID
- NCT01708629
- Acronym / sponsor ID
- AMAGINE-3 / 20120104
- Conditions
- Plaque Psoriasis
- Keywords
- psoriasis, brodalumab, AMG 827
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 1,881 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Oct 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 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.
Detailed description
This study 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 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 brodalumabAlso: Siliq210 mg brodalumab administered SC | Drug | 210 mg brodalumab, Placebo |
| 140 mg brodalumabAlso: Siliq140 mg brodalumab administered SC | Drug | 140 mg brodalumab |
| ustekinumabAlso: Stelara45 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 Psoriasis Area Severity Index (PASI) 75 at Week 12
Time frame: 12 weeks
The Psoriasis Area and Severity Index Score is used as a scale to show change from Baseline of study to a certain point. PASI Score ranges from (0) no disease to (72) maximal disease. The proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75, was assessed.
Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo
Time frame: 12 weeks
Static Physician Global Assessment (sPGA) measures the physician's impression of the disease. Possible scores are (0 [clear] to 5 [severe]). Success was defined by a score of 0 or 1 (clear to almost clear).
Results and safety
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 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
157 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 Plaque Psoriasis, run by Bausch Health Americas, Inc. at 157 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 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 157 sites in United States, Canada, Poland, Australia, Belgium 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 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 Severity Index (PASI) 75 at Week 12 (time frame: 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 NCT01708629, 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 3 Jan 2020.