Trial · NCT03827798
Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa
NCT03827798, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2026-02-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa. Trials, record NCT03827798. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03827798
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa
- NCT number
- NCT03827798
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 248 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Hidradenitis Suppurativa
- Interventions
- CFZ533, Placebo to CFZ533, LYS006, Placebo to LYS006, MAS825, Placebo to MAS825, LOU064 25mg, LOU064 100mg, Placebo to LOU064, VAY736, Placebo to VAY736
- First posted
- 2019-02-01
- Last updated
- 2026-10-16
- Results first posted
- 2026-02-06
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Clinical Response Measured by Simplified Hidradenitis Suppurativa (sHiSCR) | Baseline, Week 16 | sHiSCR was defined as at least a 50 percent (%) reduction in abscess and inflammatory nodule (AN) counts, and no increase in draining fistula count related to baseline. The primary variable was modeled with the binomial distribution. A neutral non-informative Beta (1/3, 1/3) distribution was used as the prior for the response rate for all treatment groups. Based on the priors and the observed primary outcome, posterior distributions for the response rate for the investigational treatment and pooled placebo groups were computed respectively. At the time of the statistical comparison for cohorts A, B, and C, the placebo data for cohorts D and E were incomplete and therefore excluded. Similarly, during the comparison for cohort D, the placebo data for cohort E was still pending and was not included. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving Clinical Response Measured by Simplified Hidradenitis Suppurativa (sHiSCR) | Baseline, Week 16 | The Pharmacodynamic (PD) analysis set included all participants who received any study drug and had no protocol deviations with relevant impact on PD data. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Clinical Response Measured by Simplified Hidradenitis Suppurativa (sHiSCR) | Cohort A - CFZ533 600 mg | 17 | Participants | ||
| Percentage of Participants Achieving Clinical Response Measured by Simplified Hidradenitis Suppurativa (sHiSCR) | Cohort B - LYS006 20 mg | 8 | Participants | ||
| Percentage of Participants Achieving Clinical Response Measured by Simplified Hidradenitis Suppurativa (sHiSCR) | Cohort C - MAS825 300 mg | 15 | Participants | ||
| Percentage of Participants Achieving Clinical Response Measured by Simplified Hidradenitis Suppurativa (sHiSCR) | Pooled Placebo (Cohorts A, B and C) | 14 | Participants | ||
| Percentage of Participants Achieving Clinical Response Measured by Simplified Hidradenitis Suppurativa (sHiSCR) | Cohort D - LOU064 25 mg | 24 | Participants | ||
| Percentage of Participants Achieving Clinical Response Measured by Simplified Hidradenitis Suppurativa (sHiSCR) | Cohort D - LOU064 100 mg | 16 | Participants | ||
| Percentage of Participants Achieving Clinical Response Measured by Simplified Hidradenitis Suppurativa (sHiSCR) | Pooled Placebo (Cohorts A, B, C and D) | 17 | Participants | ||
| Percentage of Participants Achieving Clinical Response Measured by Simplified Hidradenitis Suppurativa (sHiSCR) | Cohort E - VAY736 300 mg | 16 | Participants | ||
| Percentage of Participants Achieving Clinical Response Measured by Simplified Hidradenitis Suppurativa (sHiSCR) | Pooled Placebo (Cohorts A, B, C, D and E) | 23 | Participants |
Source ClinicalTrials.gov
Participant flow66
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Epoch | STARTED | Cohort A - CFZ533 600 mg | 29 | |
| Treatment Epoch | STARTED | Cohort A - Placebo to CFZ533 | 16 | |
| Treatment Epoch | STARTED | Cohort B - LYS006 20 mg | 27 | |
| Treatment Epoch | STARTED | Cohort B - Placebo to LYS006 | 13 | |
| Treatment Epoch | STARTED | Cohort C - MAS825 300 mg | 33 | |
| Treatment Epoch | STARTED | Cohort C - Placebo to MAS825 | 10 | |
| Treatment Epoch | STARTED | Cohort D - LOU064 25 mg | 33 | |
| Treatment Epoch | STARTED | Cohort D - LOU064 100 mg | 33 | |
| Treatment Epoch | STARTED | Cohort D - Placebo to LOU064 | 11 | |
| Treatment Epoch | STARTED | Cohort E - VAY736 300 mg | 32 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 participant flowAdverse events416
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 | Increased tendency to bruise | Blood and lymphatic system disorders | Cohort A - CFZ533 600 mg | 0 | 29 | |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Cohort B - LYS006 20 mg | 0 | 27 | |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Cohort C - MAS825 300 mg | 0 | 33 | |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Cohort D - LOU064 25 mg | 0 | 33 | |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Cohort D - LOU064 100 mg | 2 | 33 | |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Cohort E - VAY736 300 mg | 0 | 32 | |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Pooled Placebo (Cohorts A, B, C, D and E) | 0 | 61 | |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Total | 2 | 248 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort A - CFZ533 600 mg | 2 | 29 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort B - LYS006 20 mg | 0 | 27 |
1 to 10 of 416Source ClinicalTrials.gov
See all 416 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A - CFZ533 600 mg | 0 | 29 |
| Total, all-cause mortality | Cohort B - LYS006 20 mg | 0 | 27 |
| Total, all-cause mortality | Cohort C - MAS825 300 mg | 0 | 33 |
| Total, all-cause mortality | Cohort D - LOU064 25 mg | 0 | 33 |
| Total, all-cause mortality | Cohort D - LOU064 100 mg | 0 | 33 |
| Total, all-cause mortality | Cohort E - VAY736 300 mg | 0 | 32 |
| Total, all-cause mortality | Pooled Placebo (Cohorts A, B, C, D and E) | 0 | 61 |
| Total, all-cause mortality | Total | 0 | 248 |
| Total, other adverse events | Cohort A - CFZ533 600 mg | 23 | 29 |
| Total, other adverse events | Cohort B - LYS006 20 mg | 19 | 27 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers0
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/NCT03827798
GET https://conductscience.org/api/trials/v1/NCT03827798/flow?page=2