Trial · NCT01708629

Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects

NCT01708629, Phase 3, Terminated, Bausch Health Americas, Inc.; results first posted 2020-01-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects. Trials, record NCT01708629. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01708629

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects
NCT number: NCT01708629
Status: Terminated
Phases: Phase 3
Enrollment: 1,881 participants, actual
Lead sponsor: Bausch Health Americas, Inc.
Conditions: Plaque Psoriasis
Interventions: 210 mg brodalumab, 140 mg brodalumab, ustekinumab, placebo
First posted: 2012-10-17
Last updated: 2020-01-03
Results first posted: 2020-01-03

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12	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.
Primary	Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo	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).

Source ClinicalTrials.gov

Outcomes2

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 Psoriasis Area Severity Index (PASI) 75 at Week 12	12 weeks		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo	12 weeks	sPGA was only assessed as a comparison of Brodalumab (210mg and 140mg) to Placebo.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group7

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12	210 mg Brodalumab	531	Participants
Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12	140 mg Brodalumab	435	Participants
Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12	Placebo	19	Participants
Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12	Ustekinumab	217	Participants
Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo	210 mg Brodalumab	497	Participants
Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo	140 mg Brodalumab	377	Participants
Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo	Placebo	13	Participants

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	210 mg Brodalumab	624
Overall Study	STARTED	140 mg Brodalumab	629
Overall Study	STARTED	Ustekinumab	313
Overall Study	STARTED	Placebo	315
Overall Study	COMPLETED	210 mg Brodalumab	608
Overall Study	COMPLETED	140 mg Brodalumab	604
Overall Study	COMPLETED	Ustekinumab	303
Overall Study	COMPLETED	Placebo	301
Overall Study	NOT COMPLETED	210 mg Brodalumab	16
Overall Study	NOT COMPLETED	140 mg Brodalumab	25

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events232

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
other	Nasopharyngitis	Infections and infestations	210 mg Brodalumab	31	624
other	Nasopharyngitis	Infections and infestations	140 mg Brodalumab	36	629
other	Nasopharyngitis	Infections and infestations	Placebo	22	315
other	Nasopharyngitis	Infections and infestations	Ustekinumab	16	313
other	Upper respiratory tract Infection	Infections and infestations	210 mg Brodalumab	33	624
other	Upper respiratory tract Infection	Infections and infestations	140 mg Brodalumab	19	629
other	Upper respiratory tract Infection	Infections and infestations	Placebo	17	315
other	Upper respiratory tract Infection	Infections and infestations	Ustekinumab	16	313
other	Urinary Tract Infection	Infections and infestations	210 mg Brodalumab	11	624
other	Urinary Tract Infection	Infections and infestations	140 mg Brodalumab	5	629

1 to 10 of 232Source ClinicalTrials.gov

See all 232 adverse events

Adverse 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	Placebo
Total, all-cause mortality	Ustekinumab
Total, other adverse events	210 mg Brodalumab	353	624
Total, other adverse events	140 mg Brodalumab	329	629
Total, other adverse events	Placebo	152	315
Total, other adverse events	Ustekinumab	168	313
Total, serious adverse events	210 mg Brodalumab	9	624
Total, serious adverse events	140 mg Brodalumab	10	629

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
26422722	DERIVED	PubMed
30328108	DERIVED	PubMed
30471012	DERIVED	PubMed
32207067	DERIVED	PubMed
34606048	DERIVED	PubMed
39264399	DERIVED	PubMed

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01708629

GET https://conductscience.org/api/trials/v1/NCT01708629/events?page=2

API reference For AI assistants