Trial · NCT03960268
Biomarkers In Hidradenitis Suppurativa Participants Receiving Brodalumab
NCT03960268, Early phase 1, Completed, Rockefeller University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Biomarkers In Hidradenitis Suppurativa Participants Receiving Brodalumab. Trials, record NCT03960268. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03960268
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Biomarkers In Hidradenitis Suppurativa Participants Receiving Brodalumab
- NCT number
- NCT03960268
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 10 participants, actual
- Lead sponsor
- Rockefeller University
- Conditions
- Hidradenitis Suppurativa
- Interventions
- Brodalumab
- First posted
- 2019-05-23
- Last updated
- 2020-06-04
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Biomarkers at Week 12 | Week 12 compared with baseline. | Primary Outcomes would be the change in lesional tissue levels of IL-17A, IL-17C, IL-17F and IL-23 measured in pg/mL measured in pg/mL |
| Primary | Biomarkers at Week 24 | Week 24 compared with baseline. | Primary Outcomes would be the change in lesional tissue levels of IL-17A, IL-17C, IL-17F and IL-23 measured in pg/mL measured in pg/mL |
| Primary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Week 0 to Week 24 | Incidence of Grade 2/3 adverse events during the study |
| Secondary | Clinical Response at Week 12 (as measured by HiSCR) | Week 12 compared with Baseline | Clinical Response compared to baseline as assessed by the HiSCR (Hidradenitis Suppurativa Clinical Response) Defined as a greater than or equal to 50% reduction in inflammatory lesion count (abscesses plus inflammatory nodules), and no increase in abscesses or draining fistulas at Week 12 when compared with baseline |
| Secondary | Clinical Response at Week 12 (as measured by modified Sartorius Score) | Week 12 compared with Baseline | Clinical Response compared to baseline as assessed by the modified Sartorius Score as follows: Sum of separate scoring for each affected area using the data recorded as follows: a) 3 points per anatomical region involved; b) 6 points for each fistula and 1 point for each nodule or abscess; c) 1 point when the longest distance between two relevant lesions in each affected area is \<5 cm; 3 points when it is 5-10 cm; and 9 points when it is \>10 cm; d) 9 points when there is no clear separation of lesions from adjacent normal skin and 0 points when there is. |
| Secondary | Clinical Response at Week 12 (as measured by IHS4) | Week 12 compared with Baseline | Clinical Response compared to baseline as assessed by IHS4 (International Hidradenitis Suppurativa Severity Score) using the scoring system as follows: Total= (Number of nodules x1) + (Number of abscesses x2) + (Number of draining sinuses/fistulae x4) |
| Secondary | Clinical Response at Week 24 (as measured by HiSCR) | Week 24 compared with Baseline | Clinical Response compared to baseline as assessed by the HiSCR (Hidradenitis Suppurativa Clinical Response) Defined as a greater than or equal to 50% reduction in inflammatory lesion count (abscesses plus inflammatory nodules), and no increase in abscesses or draining fistulas at Week 24 when compared with baseline |
| Secondary | Clinical Response at Week 24 (as measured by modified Sartorius Score) | Week 24 compared with Baseline | Clinical Response compared to baseline as assessed by the modified Sartorius Score as follows: Sum of separate scoring for each affected area using the data recorded as follows: a) 3 points per anatomical region involved; b) 6 points for each fistula and 1 point for each nodule or abscess; c) 1 point when the longest distance between two relevant lesions in each affected area is \<5 cm; 3 points when it is 5-10 cm; and 9 points when it is \>10 cm; d) 9 points when there is no clear separation of lesions from adjacent normal skin and 0 points when there is. |
| Secondary | Clinical Response at Week 24 (as measured by IHS4) | Week 24 compared with Baseline | Clinical Response compared to baseline as assessed by IHS4 (International Hidradenitis Suppurativa Severity Score) using the scoring system as follows: Total= (Number of nodules x1) + (Number of abscesses x2) + (Number of draining sinuses/fistulae x4) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33548397 | 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.
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/NCT03960268
GET https://conductscience.org/api/trials/v1/NCT03960268/registered