Trial · NCT01708590

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

NCT01708590, 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, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects. Trials, record NCT01708590. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01708590

On this page

Trial

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

Title: Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects
NCT number: NCT01708590
Status: Terminated
Phases: Phase 3
Enrollment: 661 participants, actual
Lead sponsor: Bausch Health Americas, Inc.
Conditions: Psoriasis
Interventions: 210 mg brodalumab, 140 mg brodalumab, placebo
First posted: 2012-10-17
Last updated: 2020-01-03
Other registries' IDs: eudract:2012-000651-13
Results first posted: 2020-01-03

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 Psoriasis Area and Severity Index (PASI) 75 at Week 12	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.
Primary	Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12	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
Secondary	Percentage of Participants With Static Physicians Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 52	Week 0 - 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.

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 Psoriasis Area and Severity Index (PASI) 75 at Week 12	0-12 weeks	Data collected is based off of the data from the induction phase.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12	0 - 12 Weeks	Data reported is based off of the data collected from the induction phase	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage of Participants With Static Physicians Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 52	Week 0 - Week 52	Only subjects with efficacy data available at Week 52 were included in the analysis.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group10

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 and Severity Index (PASI) 75 at Week 12	Induction Phase: 210 mg Brodalumab	185	Participants
Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12	Induction Phase: 140 mg Brodalumab	132	Participants
Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12	Induction Phase: Placebo	6	Participants
Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12	Induction Phase: 210 mg Brodalumab	168	Participants
Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12	Induction Phase: 140 mg Brodalumab	118	Participants
Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12	Induction Phase: Placebo	3	Participants
Percentage of Participants With Static Physicians Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 52	Withdrawal Phase: Placebo (140mg)	3	Participants
Percentage of Participants With Static Physicians Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 52	Withdrawal Phase: 140mg Brodalumab Q2W	40	Participants
Percentage of Participants With Static Physicians Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 52	Withdrawal Phase: Placebo (210mg)	0	Participants
Percentage of Participants With Static Physicians Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 52	Withdrawl Phase: 210mg Brodalumab Q2W	69	Participants

Source ClinicalTrials.gov

Participant flow42

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

Period	Milestone	Group	Participants
Induction Phase	STARTED	Induction Phase: 210 mg Brodalumab	222
Induction Phase	STARTED	Induction Phase: 140 mg Brodalumab	219
Induction Phase	STARTED	Induction Phase: Placebo	220
Induction Phase	STARTED	Withdrawal Phase: Placebo (140mg)	0
Induction Phase	STARTED	Withdrawal Phase: 140mg Brodalumab Q2W	0
Induction Phase	STARTED	Withdrawal Phase: Placebo (210mg)	0
Induction Phase	STARTED	Withdrawl Phase: 210mg Brodalumab Q2W	0
Induction Phase	COMPLETED	Induction Phase: 210 mg Brodalumab	212
Induction Phase	COMPLETED	Induction Phase: 140 mg Brodalumab	212
Induction Phase	COMPLETED	Induction Phase: Placebo	209

1 to 10 of 42Source ClinicalTrials.gov

See all 42 participant flow

Adverse events90

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	Upper Respiratory Tract Infection	Infections and infestations	210 mg Brodalumab	18	222	18
other	Upper Respiratory Tract Infection	Infections and infestations	140 mg Brodalumab	18	219	18
other	Upper Respiratory Tract Infection	Infections and infestations	Placebo	14	220	14
other	Headache	Nervous system disorders	210 mg Brodalumab	11	222	11
other	Headache	Nervous system disorders	140 mg Brodalumab	12	219	12
other	Headache	Nervous system disorders	Placebo	7	220	7
other	Arthralgia	Injury, poisoning and procedural complications	210 mg Brodalumab	6	222	6
other	Arthralgia	Injury, poisoning and procedural complications	140 mg Brodalumab	10	219	10
other	Arthralgia	Injury, poisoning and procedural complications	Placebo	6	220	6
other	Hypertension	Cardiac disorders	210 mg Brodalumab	2	222	2

1 to 10 of 90Source ClinicalTrials.gov

See all 90 adverse events

Adverse event totals9

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, other adverse events	210 mg Brodalumab	85	222
Total, other adverse events	140 mg Brodalumab	91	219
Total, other adverse events	Placebo	46	220
Total, serious adverse events	210 mg Brodalumab	4	222
Total, serious adverse events	140 mg Brodalumab	6	219
Total, serious adverse events	Placebo	3	220

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32207067	DERIVED

Source 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/NCT01708590

GET https://conductscience.org/api/trials/v1/NCT01708590/flow?page=2

API reference For AI assistants