Trial · NCT01708603
P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis
NCT01708603, Phase 3, Terminated, Bausch Health Americas, Inc.; results first posted 2020-01-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis. Trials, record NCT01708603. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01708603
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis
- NCT number
- NCT01708603
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,831 participants, actual
- Lead sponsor
- Bausch Health Americas, Inc.
- Conditions
- Moderate to Severe Plaque Psoriasis
- Interventions
- 210 mg brodalumab, 140 mg brodalumab, ustekinumab, placebo
- First posted
- 2012-10-17
- Last updated
- 2020-01-06
- Results first posted
- 2020-01-06
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 | 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). |
| Primary | Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 | 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. |
| Primary | Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12 | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 | 12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 | 12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12 | 12 Weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 | 210 mg Brodalumab | 481 | Participants | ||
| Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 | 140 mg Brodalumab | 354 | Participants | ||
| Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 | Placebo | 12 | Participants | ||
| Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 | Ustekinumab | 183 | Participants | ||
| Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 | 210 mg Brodalumab | 528 | Participants | ||
| Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 | 140 mg Brodalumab | 406 | Participants | ||
| Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 | Placebo | 25 | Participants | ||
| Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 | Ustekinumab | 210 | Participants | ||
| Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12 | Brodalumab 210mg | 272 | Participants | ||
| Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12 | Brodalumab 140mg | 157 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 210 mg Brodalumab | 612 | |
| Overall Study | STARTED | 140 mg Brodalumab | 610 | |
| Overall Study | STARTED | Ustekinumab | 300 | |
| Overall Study | STARTED | Placebo | 309 | |
| Overall Study | COMPLETED | 210 mg Brodalumab | 597 | |
| Overall Study | COMPLETED | 140 mg Brodalumab | 588 | |
| Overall Study | COMPLETED | Ustekinumab | 291 | |
| Overall Study | COMPLETED | Placebo | 300 | |
| Overall Study | NOT COMPLETED | 210 mg Brodalumab | 15 | |
| Overall Study | NOT COMPLETED | 140 mg Brodalumab | 22 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events388
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | 210 mg Brodalumab | 45 | 612 | |
| other | Nasopharyngitis | Infections and infestations | 140 mg Brodalumab | 45 | 610 | |
| other | Nasopharyngitis | Infections and infestations | Ustekinumab | 18 | 300 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 14 | 309 | |
| other | Upper respiratory Tract infection | Infections and infestations | 210 mg Brodalumab | 33 | 612 | |
| other | Upper respiratory Tract infection | Infections and infestations | 140 mg Brodalumab | 30 | 610 | |
| other | Upper respiratory Tract infection | Infections and infestations | Ustekinumab | 20 | 300 | |
| other | Upper respiratory Tract infection | Infections and infestations | Placebo | 23 | 309 | |
| other | Bronchitis | Infections and infestations | 210 mg Brodalumab | 12 | 612 | |
| other | Bronchitis | Infections and infestations | 140 mg Brodalumab | 3 | 610 |
1 to 10 of 388Source ClinicalTrials.gov
See all 388 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 210 mg Brodalumab | ||
| Total, all-cause mortality | 140 mg Brodalumab | ||
| Total, all-cause mortality | Ustekinumab | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | 210 mg Brodalumab | 354 | 612 |
| Total, other adverse events | 140 mg Brodalumab | 365 | 610 |
| Total, other adverse events | Ustekinumab | 177 | 300 |
| Total, other adverse events | Placebo | 165 | 309 |
| Total, serious adverse events | 210 mg Brodalumab | 6 | 612 |
| Total, serious adverse events | 140 mg Brodalumab | 13 | 610 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01708603
GET https://conductscience.org/api/trials/v1/NCT01708603/events?page=2