Trial · NCT02896127

Study of Efficacy and Safety of Secukinumab in Patients With Ankylosing Spondylitis

NCT02896127, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2020-12-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Efficacy and Safety of Secukinumab in Patients With Ankylosing Spondylitis. Trials, record NCT02896127. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02896127

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Efficacy and Safety of Secukinumab in Patients With Ankylosing Spondylitis
NCT number: NCT02896127
Status: Completed
Phases: Phase 3
Enrollment: 458 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Ankylosing Spondyloarthritis
Interventions: Secukinumab, Placebo
First posted: 2016-09-12
Last updated: 2020-12-30
Other registries' IDs: eudract:2015-005021-39
Results first posted: 2020-12-30

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	The Proportion of Participants Who Achieve an ASAS 20 Response (Assessment of SpondyloArthritis International Society Criteria)	Week 16	ASAS20 response is defined as an improvement of ≥20% and ≥1 units on a scale of 10 in at least three of the four ASAS main domains and no worsening of ≥20% and ≥1 unit on a scale of 10 in the remaining domain
Secondary	The Proportion of Participants Who Achieve an ASAS40 Response	The secondary outcome analysis occurred only at Week 16. Thus, while data were collected beyond week 16, they were not part of the secondary outcomes.	ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain The number analyzed for some of continuous outcome variables are the number of participants for whom the specific outcome data were available. Thus the number for these variables differs from the FAS.
Secondary	Change in hsCRP Over Time	Change from baseline to Week 16. The secondary outcome analysis occurred only at Week 16. Thus, while data were collected beyond week 16, they were not part of the secondary outcomes.	hsCRP is measured as a marker of inflammation from blood samples during the study The number analyzed for some of continuous outcome variables are the number of participants for whom the specific outcome data were available. Thus the number for these variables differs from the FAS.
Secondary	Percentage of Participants Who Achieve an ASAS 5/6 at Week 16	Week 16: The secondary outcome analysis occurred only at Week 16. Thus, while data were collected beyond week 16, they were not part of the secondary outcomes.	The ASAS 5/6 improvement criteria is an improvement of ≥20% in at least five of all six domains The number analyzed for some of continuous outcome variables are the number of participants for whom the specific outcome data were available. Thus the number for these variables differs from the FAS.
Secondary	Participants With BASDAI Response at 16 Weeks	The secondary outcome analysis occurred only at Week 16. Thus, while data were collected beyond week 16, they were not part of the secondary outcomes.	The BASDAI or Bath Ankylosing Spondylitis Disease Activity Index consists of a 0 through 10 scale (0 being no problem and 10 being the worst problem, captured as a continuous VAS), which is used to answer 6 questions pertaining to the 5 major symptoms of AS The number analyzed for some of continuous outcome variables are the number of participants for whom the specific outcome data were available. Thus the number for these variables differs from the FAS.
Secondary	Change in Short Form (36) - PCS Responders (Improvement of >= 2.5 Points) at Week 16	The secondary outcome analysis occurred only at Week 16. Thus, while data were collected beyond week 16, they were not part of the secondary outcomes.	The Physical Component Summary (PCS) SF-36 is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions The number analyzed for some of continuous outcome variables are the number of participants for whom the specific outcome data were available. Thus the number for these variables differs from the FAS.
Secondary	Change in ASQoL Score Over Time	change from baseline to Week 16	The Ankylosing Spondylitis Quality of Life (ASQoL) is an instrument to assess health-related quality of life among adult patients with Ankylosing Spondylitis. Each statement on the ASQoL is given a score of "1" or "0". A score of "1" is given where the item is affirmed, indicating adverse QoL. All item scores are summed to give a total score or index. Scores can range from 0 (good QoL) to 18 (poor QoL).
Secondary	The Proportion of Patients Who Achieve an ASAS Partial Remission	Week 16	The The Assessment in SpondyloArthritis International Society (ASAS) partial remission criteria are defined as a value not above 2 units in each of the four main domains on a scale of 10 The number analyzed for some of continuous outcome variables are the number of participants for whom the specific outcome data were available. Thus the number for these variables differs from the FAS.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Proportion of Participants Who Achieve an ASAS 20 Response (Assessment of SpondyloArthritis International Society Criteria)	Week 16	Full Analysis Set (FAS) was comprised of all subjects from the randomized set to whom study treatment had been assigned. Following the intent-to-treat principle, subjects were evaluated according to the treatment assigned to at randomization, but actual stratum, if stratified randomization was used.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	The Proportion of Participants Who Achieve an ASAS40 Response	The secondary outcome analysis occurred only at Week 16. Thus, while data were collected beyond week 16, they were not part of the secondary outcomes.	Full Analysis Set (FAS)	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in hsCRP Over Time	Change from baseline to Week 16. The secondary outcome analysis occurred only at Week 16. Thus, while data were collected beyond week 16, they were not part of the secondary outcomes.	FAS	mg/l	MEAN
SECONDARY	Percentage of Participants Who Achieve an ASAS 5/6 at Week 16	Week 16: The secondary outcome analysis occurred only at Week 16. Thus, while data were collected beyond week 16, they were not part of the secondary outcomes.	FAS	percentage of participants	NUMBER
SECONDARY	Participants With BASDAI Response at 16 Weeks	The secondary outcome analysis occurred only at Week 16. Thus, while data were collected beyond week 16, they were not part of the secondary outcomes.	FAS	percent of participants	NUMBER
SECONDARY	Change in Short Form (36) - PCS Responders (Improvement of >= 2.5 Points) at Week 16	The secondary outcome analysis occurred only at Week 16. Thus, while data were collected beyond week 16, they were not part of the secondary outcomes.	FAS	percent of participants	NUMBER
SECONDARY	Change in ASQoL Score Over Time	change from baseline to Week 16	FAS	scores	MEAN
SECONDARY	The Proportion of Patients Who Achieve an ASAS Partial Remission	Week 16	FAS	percent of participants	NUMBER

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
The Proportion of Participants Who Achieve an ASAS 20 Response (Assessment of SpondyloArthritis International Society Criteria)	Secukinumab	178		Participants
The Proportion of Participants Who Achieve an ASAS 20 Response (Assessment of SpondyloArthritis International Society Criteria)	Placebo	56		Participants
The Proportion of Participants Who Achieve an ASAS40 Response	Secukinumab	138		Participants
The Proportion of Participants Who Achieve an ASAS40 Response	Placebo	27		Participants
Change in hsCRP Over Time	Secukinumab	-11.78	Standard Deviation 22.919	mg/l
Change in hsCRP Over Time	Placebo	-0.79	Standard Deviation 20.023	mg/l
Percentage of Participants Who Achieve an ASAS 5/6 at Week 16	Secukinumab	50.5	95% Confidence Interval 44.7 to 56.3	percentage of participants
Percentage of Participants Who Achieve an ASAS 5/6 at Week 16	Placebo	19.2	95% Confidence Interval 13.3 to 26.7	percentage of participants
Participants With BASDAI Response at 16 Weeks	Secukinumab	41.7	95% Confidence Interval 36.0 to 47.6	percent of participants
Participants With BASDAI Response at 16 Weeks	Placebo	22.6	95% Confidence Interval 16.3 to 30.4	percent of participants

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
COMPLETED WEEK 52	STARTED	Secukinumab	305
COMPLETED WEEK 52	STARTED	Placebo	153
COMPLETED WEEK 52	COMPLETED	Secukinumab	278
COMPLETED WEEK 52	COMPLETED	Placebo	142
COMPLETED WEEK 52	NOT COMPLETED	Secukinumab	27
COMPLETED WEEK 52	NOT COMPLETED	Placebo	11
COMPLETED POST-TREATMENT FOLLOW UP	STARTED	Secukinumab	280
COMPLETED POST-TREATMENT FOLLOW UP	STARTED	Placebo	139
COMPLETED POST-TREATMENT FOLLOW UP	COMPLETED	Secukinumab	276
COMPLETED POST-TREATMENT FOLLOW UP	COMPLETED	Placebo	134

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events126

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
other	Abdominal discomfort	Gastrointestinal disorders	Any AIN457 150 mg	15	453
other	Abdominal discomfort	Gastrointestinal disorders	Placebo	1	153
other	Diarrhoea	Gastrointestinal disorders	Any AIN457 150 mg	35	453
other	Diarrhoea	Gastrointestinal disorders	Placebo	6	153
other	Mouth ulceration	Gastrointestinal disorders	Any AIN457 150 mg	18	453
other	Mouth ulceration	Gastrointestinal disorders	Placebo	2	153
other	Fatigue	General disorders	Any AIN457 150 mg	12	453
other	Fatigue	General disorders	Placebo	0	153
other	Hepatic function abnormal	Hepatobiliary disorders	Any AIN457 150 mg	24	453
other	Hepatic function abnormal	Hepatobiliary disorders	Placebo	3	153

1 to 10 of 126Source ClinicalTrials.gov

See all 126 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Any AIN457 150 mg	0	453
Total, all-cause mortality	Placebo	0	153
Total, other adverse events	Any AIN457 150 mg	282	453
Total, other adverse events	Placebo	60	153
Total, serious adverse events	Any AIN457 150 mg	33	453
Total, serious adverse events	Placebo	3	153

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32925287	DERIVED	PubMed
34618347	DERIVED	PubMed
35305260	DERIVED	PubMed
41965705	DERIVED	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 comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Secukinumab vs Placebo: The Proportion of Participants Who Achieve an ASAS40 Response	Trial comparisons
Secukinumab vs Placebo: The Proportion of Participants Who Achieve an ASAS 20 Response (Assessment of SpondyloArthritis International Society Criteria)	Trial comparisons
Any AIN457 150 mg vs Placebo: deaths from any cause	Trial comparisons
Any AIN457 150 mg vs Placebo: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02896127

GET https://conductscience.org/api/trials/v1/NCT02896127/events?page=2

API reference For AI assistants