Trial · NCT03713619
This Was a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS).
NCT03713619, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2024-09-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. This Was a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS). Trials, record NCT03713619. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03713619
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- This Was a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS).
- NCT number
- NCT03713619
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 544 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Hidradenitis Suppurativa
- Interventions
- secukinumab, Placebo
- First posted
- 2018-10-22
- Last updated
- 2024-10-09
- Other registries' IDs
- eudract:2018-002063-26
- Results first posted
- 2024-09-25
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR50) | 16 weeks | HiSCR50 at Week 16 is defined as at least a 50% decrease in Abscess and inflammatory Nodule (AN) count compared to baseline with no increase in the number of abscesses and/or in the number of draining fistulas from baseline to Week 16. The baseline is defined as the last assessment (including unscheduled visits) obtained before/on the day of the first administration of the study treatment, or on the randomization date if there had been no drug administration. This endpoint was analyzed by logistic regression. |
| Secondary | Percentage Change From Baseline in AN50 Count at Week 16 | Baseline, 16 weeks | The HS affected areas, e.g. right and left axillary (armpit), right and left gluteal ("buttock"), right and left inguinal-femoral (groin), perineal, pubic, sternal, right and left sub-mammary (breast) and others were assessed by the physician for abscesses, inflammatory nodules, draining fistulas, total fistulas, and other lesions. Inflammatory lesions, including abscesses, nodules, draining fistulae, total fistulae and other lesions were counted. The analysis method for percentage change from baseline in abscesses and inflammatory nodules (AN) count at Week 16 was an ANCOVA model. |
| Secondary | Percentage of Participants With Hidradenitis Suppurativa (HS) Flares | 16 weeks | Percentage of participants who experience at least one flare over 16 weeks. A flare is defined as at least a 25% increase in abscesses and inflammatory nodules (AN) count with a minimum increase of 2 AN relative to baseline. This endpoint was analyzed by logistic regression. |
| Secondary | Percentage of Participants Achieving NRS30 | Baseline, week 16 | Patients achieving Numerical Rating Scale score of 30 (NRS30) at week 16, defined as at least a 30% reduction and at least one unit reduction from baseline in the Patient's Global assessment of Skin Pain (where range 0 \[no skin pain\] to 10 \[worst skin pain\]). This endpoint was analyzed by logistic regression. |
Source ClinicalTrials.gov
Outcomes4
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 Hidradenitis Suppurativa Clinical Response (HiSCR50) | 16 weeks | Full analysis set (FAS) | Percentage of participants | NUMBER |
| SECONDARY | Percentage Change From Baseline in AN50 Count at Week 16 | Baseline, 16 weeks | FAS | percentage change from baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Hidradenitis Suppurativa (HS) Flares | 16 weeks | FAS | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving NRS30 | Baseline, week 16 | FAS restricted to participants with baseline NRS score greater or equal to 3 | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR50) | Secukinumab 1 - Q2W | 45.0 | Percentage of participants | ||
| Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR50) | Secukinumab 2 - Q4W | 41.8 | Percentage of participants | ||
| Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR50) | Placebo | 33.7 | Percentage of participants | ||
| Percentage Change From Baseline in AN50 Count at Week 16 | Secukinumab 1 - Q2W | -46.8 | Standard Error 3.33 | percentage change from baseline | |
| Percentage Change From Baseline in AN50 Count at Week 16 | Secukinumab 2 - Q4W | -42.4 | Standard Error 4.01 | percentage change from baseline | |
| Percentage Change From Baseline in AN50 Count at Week 16 | Placebo | -24.3 | Standard Error 4.33 | percentage change from baseline | |
| Percentage of Participants With Hidradenitis Suppurativa (HS) Flares | Secukinumab 1 - Q2W | 15.4 | Percentage of participants | ||
| Percentage of Participants With Hidradenitis Suppurativa (HS) Flares | Secukinumab 2 - Q4W | 23.2 | Percentage of participants | ||
| Percentage of Participants With Hidradenitis Suppurativa (HS) Flares | Placebo 2 | 29.0 | Percentage of participants | ||
| Percentage of Participants Achieving NRS30 | Secukinumab 1 - Q2W | 34.1 | Percentage of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow35
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 (Until Week 16) | STARTED | Secukinumab - Q2W | 182 | |
| Treatment Period 1 (Until Week 16) | STARTED | Secukinumab - Q4W | 181 | |
| Treatment Period 1 (Until Week 16) | STARTED | Placebo | 181 | |
| Treatment Period 1 (Until Week 16) | STARTED | Placebo - Re-randomized to Secukinumab Q2W | 0 | |
| Treatment Period 1 (Until Week 16) | STARTED | Placebo - Re-randomized to Secukinumab Q4W | 0 | |
| Treatment Period 1 (Until Week 16) | Full Analysis Set (FAS) | Secukinumab - Q2W | 181 | |
| Treatment Period 1 (Until Week 16) | Full Analysis Set (FAS) | Secukinumab - Q4W | 180 | |
| Treatment Period 1 (Until Week 16) | Full Analysis Set (FAS) | Placebo | 180 | |
| Treatment Period 1 (Until Week 16) | Full Analysis Set (FAS) | Placebo - Re-randomized to Secukinumab Q2W | 0 | |
| Treatment Period 1 (Until Week 16) | Full Analysis Set (FAS) | Placebo - Re-randomized to Secukinumab Q4W | 0 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 participant flowAdverse events606
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 | Abdominal pain | Gastrointestinal disorders | AIN457 Q2W | 7 | 181 | |
| other | Abdominal pain | Gastrointestinal disorders | AIN457 Q4W | 6 | 180 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 1 | 180 | |
| other | Abdominal pain | Gastrointestinal disorders | Any AIN457 Q2W | 8 | 266 | |
| other | Abdominal pain | Gastrointestinal disorders | Any AIN457 Q4W | 10 | 267 | |
| other | Abdominal pain | Gastrointestinal disorders | Any AIN457 | 18 | 533 | |
| other | Abdominal pain upper | Gastrointestinal disorders | AIN457 Q2W | 4 | 181 | |
| other | Abdominal pain upper | Gastrointestinal disorders | AIN457 Q4W | 5 | 180 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 1 | 180 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Any AIN457 Q2W | 4 | 266 |
1 to 10 of 606Source ClinicalTrials.gov
See all 606 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AIN457 Q2W | 0 | 181 |
| Total, all-cause mortality | AIN457 Q4W | 0 | 180 |
| Total, all-cause mortality | Placebo | 0 | 180 |
| Total, all-cause mortality | Any AIN457 Q2W | 0 | 266 |
| Total, all-cause mortality | Any AIN457 Q4W | 0 | 267 |
| Total, all-cause mortality | Any AIN457 | 0 | 533 |
| Total, other adverse events | AIN457 Q2W | 135 | 181 |
| Total, other adverse events | AIN457 Q4W | 132 | 180 |
| Total, other adverse events | Placebo | 88 | 180 |
| Total, other adverse events | Any AIN457 Q2W | 184 | 266 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
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/NCT03713619
GET https://conductscience.org/api/trials/v1/NCT03713619/flow?page=2