Trial · NCT03403036
Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed IL-17A Therapies
NCT03403036, Phase 4, Completed, Icahn School of Medicine at Mount Sinai; results first posted 2019-07-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed IL-17A Therapies. Trials, record NCT03403036. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03403036
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Brodalumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed IL-17A Therapies
- NCT number
- NCT03403036
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 39 participants, actual
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Conditions
- Psoriasis
- Interventions
- Brodalumab
- First posted
- 2018-01-18
- Last updated
- 2021-03-10
- Results first posted
- 2019-07-09
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Physician's Global Assessment (sPGA) Score 0 or 1 | 16 weeks | Number of patients achieving a score of "0-clear" or "1-almost clear" in the sPGA score after 16 weeks of treatment to measure efficacy. Static Physician Global Assessment (sPGA) - 3 categories induration, erythema, and scaling, scored 0-4, these 3 categories averaged giving total score from 0-4, with higher score indicating more symptoms. |
| Secondary | Number of Participants With Psoriasis Area and Severity Index (PASI) Score Improvement | 16 weeks | PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). Number of participants with 75%, 90%, and 100% reduction in the PASI score, respectively, PASI-75, PASI-90, and PASI-100 who completed the trial at week 16. |
| Secondary | Number of Adverse Events | 16 weeks | Number of adverse events as a measure of safety |
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 | Number of Patients With Physician's Global Assessment (sPGA) Score 0 or 1 | 16 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Psoriasis Area and Severity Index (PASI) Score Improvement | 16 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Adverse Events | 16 weeks | events | NUMBER |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Physician's Global Assessment (sPGA) Score 0 or 1 | Brodalumab | 24 | Participants | ||
| Number of Participants With Psoriasis Area and Severity Index (PASI) Score Improvement | Brodalumab | PASI-75 | 26 | Participants | |
| Number of Participants With Psoriasis Area and Severity Index (PASI) Score Improvement | Brodalumab | PASI-90 | 17 | Participants | |
| Number of Participants With Psoriasis Area and Severity Index (PASI) Score Improvement | Brodalumab | PASI-100 | 11 | Participants | |
| Number of Adverse Events | Brodalumab | 6 | events |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Brodalumab | 39 | |
| Overall Study | COMPLETED | Brodalumab | 34 | |
| Overall Study | NOT COMPLETED | Brodalumab | 5 |
Source ClinicalTrials.gov
Adverse events6
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 | Corneal Ulcer | Eye disorders | Brodalumab | 1 | 39 | 1 |
| other | Tooth Abscess | Infections and infestations | Brodalumab | 1 | 39 | 1 |
| other | Allergic Sinusitis | Immune system disorders | Brodalumab | 1 | 39 | 1 |
| other | Folliculitis | Skin and subcutaneous tissue disorders | Brodalumab | 1 | 39 | 1 |
| other | Pre-Diabetes | Endocrine disorders | Brodalumab | 1 | 39 | 1 |
| other | Sciatica | Musculoskeletal and connective tissue disorders | Brodalumab | 1 | 39 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Brodalumab | 0 | 39 |
| Total, other adverse events | Brodalumab | 6 | 39 |
| Total, serious adverse events | Brodalumab | 0 | 39 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT03403036
GET https://conductscience.org/api/trials/v1/NCT03403036/registered