Trial · NCT04179175
Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa
NCT04179175, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2024-06-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa. Trials, record NCT04179175. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04179175
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa
- NCT number
- NCT04179175
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 702 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Hidradenitis Suppurativa
- Interventions
- secukinumab, secukinumab
- First posted
- 2019-11-27
- Last updated
- 2026-08-21
- Results first posted
- 2024-06-21
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders | Up to 52 weeks: from randomization at the extension study (Week 52) up to Week 104 or loss of response. Study day is defined with respect to the core studies. | Loss of response was defined as: * at least a 50% increase in abscess and/or nodules (AN) count compared to the average AN count from the 3 previous visits or at Week 52, whichever is lower and the increase was at least of 3 AN. * at least a 30% increase in AN compared to the average AN count from the 3 previous visits or Week 52, whichever is lower, with an increase of at least 2 AN and a further increase in the AN count of at least 2 AN at a re-assessment visit within 2-4 weeks |
| Primary | Incidence Rate of Participants Achieving Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders | Up to 52 weeks: from randomization at the extension study (Week 52) up to Week 104 or loss of response. Study day is defined with respect to the core studies. | The incidence rate of participants achieving Loss of Response (LOR) was based on the primary estimand. * Day 1 = Date of 1st dose intake in the extension study. * Subjects at risk = Subjects who did not have LOR and were not censored before or at the start of the specified time interval. * Incidence rate (%) = (number of subjects with LOR / number of subjects at risk) x 100. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events | Up to 216 weeks: from randomization at the extension study (Week 52) up to Week 268. Study day is defined with respect to the core studies. | To assess the long-term safety and tolerability of Secukinumab in subjects with moderate to severe hidradenitis suppurativa (HS) |
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 | Time to Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders | Up to 52 weeks: from randomization at the extension study (Week 52) up to Week 104 or loss of response. Study day is defined with respect to the core studies. | Full Analysis Set of HiSCR responders (FAS-R) | Days | MEDIAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events | Up to 216 weeks: from randomization at the extension study (Week 52) up to Week 268. Study day is defined with respect to the core studies. | |||
| PRIMARY | Incidence Rate of Participants Achieving Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders | Up to 52 weeks: from randomization at the extension study (Week 52) up to Week 104 or loss of response. Study day is defined with respect to the core studies. | Full Analysis Set of HiSCR responders (FAS-R) with an available value for the outcome measure. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders | AIN457 Q2WR-Q2W | 283 | 95% Confidence Interval 176 to NA | Days | |
| Time to Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders | AIN457 Q2WR-PBO | 239 | 95% Confidence Interval 120 to NA | Days | |
| Time to Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders | AIN457 Q4WR-Q4W | 365 | 95% Confidence Interval 225 to NA | Days | |
| Time to Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders | AIN457 Q4WR-PBO | 171 | 95% Confidence Interval 113 to 337 | Days | |
| Incidence Rate of Participants Achieving Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders | AIN457 Q2WR-Q2W | Day 1 | 0.0 | Percentage of participants | |
| Incidence Rate of Participants Achieving Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders | AIN457 Q2WR-PBO | Day 1 | 0.0 | Percentage of participants | |
| Incidence Rate of Participants Achieving Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders | AIN457 Q4WR-Q4W | Day 1 | 0.0 | Percentage of participants | |
| Incidence Rate of Participants Achieving Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders | AIN457 Q4WR-PBO | Day 1 | 0.0 | Percentage of participants | |
| Incidence Rate of Participants Achieving Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders | AIN457 Q2WR-Q2W | 2 to 85 days | 26.9 | Percentage of participants | |
| Incidence Rate of Participants Achieving Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders | AIN457 Q2WR-PBO | 2 to 85 days | 23.9 | Percentage of participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow42
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AIN457 Q2WR-Q2W | 136 | |
| Overall Study | STARTED | AIN457 Q2WR-PBO | 71 | |
| Overall Study | STARTED | AIN457 Q4WR-Q4W | 121 | |
| Overall Study | STARTED | AIN457 Q4WR-PBO | 63 | |
| Overall Study | STARTED | AIN457 Q2WNR-Q2W | 151 | |
| Overall Study | STARTED | AIN457 Q4WNR-Q2W | 157 | |
| Overall Study | Full Analysis Set of HiSCR Responders (FAS-R) | AIN457 Q2WR-Q2W | 136 | |
| Overall Study | Full Analysis Set of HiSCR Responders (FAS-R) | AIN457 Q2WR-PBO | 71 | |
| Overall Study | Full Analysis Set of HiSCR Responders (FAS-R) | AIN457 Q4WR-Q4W | 121 | |
| Overall Study | Full Analysis Set of HiSCR Responders (FAS-R) | AIN457 Q4WR-PBO | 63 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 participant flowAdverse events1,016
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 | Anaemia | Blood and lymphatic system disorders | AIN457 Q2WR-Q2W | 0 | 137 | |
| other | Anaemia | Blood and lymphatic system disorders | AIN457 Q2WR-PBO | 0 | 70 | |
| other | Anaemia | Blood and lymphatic system disorders | AIN457 Q4WR-Q4W | 0 | 121 | |
| other | Anaemia | Blood and lymphatic system disorders | AIN457 Q4WR-PBO | 0 | 63 | |
| other | Anaemia | Blood and lymphatic system disorders | Any AIN457 Q4W | 1 | 180 | |
| other | Anaemia | Blood and lymphatic system disorders | Any AIN457 Q2W | 8 | 637 | |
| other | Anaemia | Blood and lymphatic system disorders | Any AIN457 | 9 | 687 | |
| other | Anaemia | Blood and lymphatic system disorders | AIN457 NR | 8 | 307 | |
| other | Diarrhoea | Gastrointestinal disorders | AIN457 Q2WR-Q2W | 0 | 137 | |
| other | Diarrhoea | Gastrointestinal disorders | AIN457 Q2WR-PBO | 1 | 70 |
1 to 10 of 1,016Source ClinicalTrials.gov
See all 1,016 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AIN457 Q2WR-Q2W | 0 | 137 |
| Total, all-cause mortality | AIN457 Q2WR-PBO | 0 | 70 |
| Total, all-cause mortality | AIN457 Q4WR-Q4W | 0 | 121 |
| Total, all-cause mortality | AIN457 Q4WR-PBO | 0 | 63 |
| Total, all-cause mortality | Any AIN457 Q4W | 0 | 180 |
| Total, all-cause mortality | Any AIN457 Q2W | 0 | 637 |
| Total, all-cause mortality | Any AIN457 | 0 | 687 |
| Total, all-cause mortality | AIN457 NR | 0 | 307 |
| Total, other adverse events | AIN457 Q2WR-Q2W | 44 | 137 |
| Total, other adverse events | AIN457 Q2WR-PBO | 23 | 70 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39611771 | 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/NCT04179175
GET https://conductscience.org/api/trials/v1/NCT04179175/results?page=2