Trial · NCT03765788
A Placebo-controlled Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab in Giant Cell Arteritis
NCT03765788, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2023-04-26
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Placebo-controlled Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab in Giant Cell Arteritis. Trials, record NCT03765788. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03765788
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Placebo-controlled Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab in Giant Cell Arteritis
- NCT number
- NCT03765788
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 52 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Giant Cell Arteritis
- Interventions
- Secukinumab 300 mg, s.c., Prednisolone, Placebo
- First posted
- 2018-12-05
- Last updated
- 2023-08-21
- Other registries' IDs
- eudract:2018-002610-12
- Results first posted
- 2023-04-26
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants in Sustained Remission Until Week 28 | Until week 28 | Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper regimen. Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of Giant Cell Arteritis (GCA) and/or erythrocyte sedimentation rate (ESR) greater than or equal to (\>/=) 30 millimeters per hour (mm/hr) and/or C-reactive Protein (CRP) (\>/=10.0 mg/L) attributable to GCA. Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the "escape arm" (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28. |
| Secondary | Percentage of Participants in Remission at Week 12 | Week 12 | Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper Regimen. Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (\>/=) 30 millimeters per hour (mm/hr) and/or CRP (\>/=10.0 mg/L) attributable to GCA. Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the "escape arm" (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28. |
| Secondary | Time to First GCA Flare After Clinical Remission | Up to Week 52 (included) | Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (\>/=) 30 millimeters per hour (mm/hr) and/or CRP (\>/=10.0 mg/L) attributable to GCA. Time to first flare after remission referred to time from first day of study treatment until first post-Baseline flare. For time to first GCA flare after remission (up to and including Week 52), patients who prematurely discontinued study treatment prior to Week 52 were censored at the time of premature discontinuation and patients who completed treatment and did not have a flare were censored at their last visit in the treatment phase. Time to first GCA flare after remission was calculated using Kaplan-Meier plot of time. |
| Secondary | Total Cumulative Prednisolone Dose Over 28 Weeks and 52 Weeks | from Baseline to week 28, from baseline to week 52 weeks | Total cumulative co-administered prednisolone treatment was summarized over time by treatment arm. Patients received a daily dose of prednisolone, which was decreased (i.e. tapered down) from Baseline to Week 26. No additional prednisolone or equivalent was permitted. |
| Secondary | Percentage of Participants With GCA Who Had Sustained Remission Until Week 52 | Until Week 52 | Remission was defined as the absence of flare. Sustained remission was defined as patients without flare until Week 52 and in adherence to the protocol prednisolone taper regimen plus prednisolone-free phase from Week 27 onwards. Flare was determined by the investigator and was defined as the recurrence after remission of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (\>/=) 30 millimeters per hour (mm/hr) and/or CRP (\>/=10.0 mg/L) attributable to GCA. Patients were classified as non-responders if they did not achieve remission within 12 weeks of Baseline (remission referred to the absence of flare), were in the "escape arm" (this referred to patients entering escape between Baseline and Week 28), prematurely discontinued study treatment prior to Week 28 (absence of flare was checked prior to study treatment administration), did not have information to evaluate sustained remission response until Week 28. |
| Secondary | Number of Participants on Prednisolone Dose ≤ 5mg/Day | Week 19, Week 28, Week 52 | Number of participants on co-administered prednisolone treatment ≤ 5mg/day who responded at Week 19, Week 26 and Week 52. Remission was defined as the absence of flare. Sustained remission was defined as the absence of flare until Week 28 and in adherence to the protocol prednisolone taper Regimen. There were 2 taper regimens: for patients on 40 to 60 mg/day prednisolone at Baseline and for patients on 25 to 40 mg/day prednisolone at Baseline depending on patients' prednisolone levels at Baseline. Prednisolone was tapered from a dose of 25 mg to 60 mg at Baseline to 1 mg at Week 26 \[last dose\]. |
| Secondary | Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS) | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52 | Clinician Reported Outcome: Physicians global assessment (PhGA) using a visual analogue scale (VAS) scale. VAS is a range of scores from 0-100, with lower change from baseline scores indicating a more favorable outcome and higher change from baseline scores indicating a greater disease activity. |
| Secondary | Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS) | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52 | Patient Reported Outcome: Patients global assessment (PGA) score using a VAS scale. VAS is a range of scores from 0-100, with lower change from baseline scores indicating a more favorable outcome and higher change from baseline scores indicating a greater disease activity. |
| Secondary | Change From Baseline in FACIT-Fatigue Scale | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52 | Patient Reported Outcome: Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue is a 13-item questionnaire with a full scale of 0 -52 that assesses self-reported fatigue and its impact upon daily activities and function. The higher the score the better functioning (less fatigue). |
| Secondary | Change From Baseline in Short-Form (SF)-36 Questionnaire | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52 | Patient Reported Outcome: The SF-36 is a standardized questionnaire used to measure health-related quality of life among healthy patients and patients with acute and chronic conditions. It consists of 8 subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. The higher the score (change from baseline) the more favorable the outcome. The values were reported by change from baseline in SF-36 domain scores. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants in Sustained Remission Until Week 28 | Until week 28 | The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants in Remission at Week 12 | Week 12 | The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to First GCA Flare After Clinical Remission | Up to Week 52 (included) | The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). | days | MEDIAN |
| SECONDARY | Total Cumulative Prednisolone Dose Over 28 Weeks and 52 Weeks | from Baseline to week 28, from baseline to week 52 weeks | The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). | milligrams | MEAN |
| SECONDARY | Percentage of Participants With GCA Who Had Sustained Remission Until Week 52 | Until Week 52 | The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants on Prednisolone Dose ≤ 5mg/Day | Week 19, Week 28, Week 52 | The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). n represents the number of participants with a value for a specific categorical variable at Week 19, 28 and 52. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Physicians Global Assessment (PhGA) of Disease Activity: Change From Baseline Score Via Visual Analogue Scale (VAS) | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52 | The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from baseline at each visit is calculated only for subjects with a value at baseline and the particular visit. | scores on a scale | MEAN |
| SECONDARY | Patients Global Assessment (PGA) of Disease Activity: Change From Baseline Via Visual Analogue Scale (VAS) | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52 | The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from baseline at each visit is calculated only for subjects with a value at baseline and the particular visit. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in FACIT-Fatigue Scale | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52 | The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from baseline at each visit is calculated only for subjects with a value at baseline and the particular visit. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Short-Form (SF)-36 Questionnaire | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 36, 44 & 52 | The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned by randomization and who received at least one dose of randomized study treatment (secukinumab or placebo). The change from baseline at each visit is calculated only for subjects with a value at baseline and the particular visit. | scores on a scale | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group286
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants in Sustained Remission Until Week 28 | Secukinumab | 19 | Participants | ||
| Percentage of Participants in Sustained Remission Until Week 28 | Placebo | 6 | Participants | ||
| Percentage of Participants in Remission at Week 12 | Secukinumab | 22 | Participants | ||
| Percentage of Participants in Remission at Week 12 | Placebo | 12 | Participants | ||
| Time to First GCA Flare After Clinical Remission | Secukinumab | NA | 95% Confidence Interval NA to NA | days | |
| Time to First GCA Flare After Clinical Remission | Placebo | 197.0 | 95% Confidence Interval 101.0 to 280.0 | days | |
| Total Cumulative Prednisolone Dose Over 28 Weeks and 52 Weeks | Secukinumab | Baseline to Week 28 | 2689.70 | Standard Deviation 935.860 | milligrams |
| Total Cumulative Prednisolone Dose Over 28 Weeks and 52 Weeks | Placebo | Baseline to Week 28 | 2693.74 | Standard Deviation 1241.907 | milligrams |
| Total Cumulative Prednisolone Dose Over 28 Weeks and 52 Weeks | Secukinumab | Baseline to Week 52 | 2841.26 | Standard Deviation 1116.192 | milligrams |
| Total Cumulative Prednisolone Dose Over 28 Weeks and 52 Weeks | Placebo | Baseline to Week 52 | 3375.58 | Standard Deviation 1720.978 | milligrams |
1 to 10 of 286Source ClinicalTrials.gov
See all 286 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Secukinumab | 27 | |
| Overall Study | STARTED | Placebo | 25 | |
| Overall Study | COMPLETED | Secukinumab | 22 | |
| Overall Study | COMPLETED | Placebo | 17 | |
| Overall Study | NOT COMPLETED | Secukinumab | 5 | |
| Overall Study | NOT COMPLETED | Placebo | 8 |
Source ClinicalTrials.gov
Adverse events231
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 | Cushingoid | Endocrine disorders | Secukinumab | 1 | 27 | |
| other | Cushingoid | Endocrine disorders | Placebo | 2 | 25 | |
| other | Cushingoid | Endocrine disorders | All Participants | 3 | 52 | |
| other | Glaucoma | Eye disorders | Secukinumab | 2 | 27 | |
| other | Glaucoma | Eye disorders | Placebo | 2 | 25 | |
| other | Glaucoma | Eye disorders | All Participants | 4 | 52 | |
| other | Vision blurred | Eye disorders | Secukinumab | 1 | 27 | |
| other | Vision blurred | Eye disorders | Placebo | 2 | 25 | |
| other | Vision blurred | Eye disorders | All Participants | 3 | 52 | |
| other | Dental caries | Gastrointestinal disorders | Secukinumab | 2 | 27 |
1 to 10 of 231Source ClinicalTrials.gov
See all 231 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Secukinumab | 1 | 27 |
| Total, all-cause mortality | Placebo | 1 | 25 |
| Total, all-cause mortality | All Participants | 2 | 52 |
| Total, other adverse events | Secukinumab | 25 | 27 |
| Total, other adverse events | Placebo | 23 | 25 |
| Total, other adverse events | All Participants | 48 | 52 |
| Total, serious adverse events | Secukinumab | 6 | 27 |
| Total, serious adverse events | Placebo | 11 | 25 |
| Total, serious adverse events | All Participants | 17 | 52 |
Source ClinicalTrials.gov
Papers2
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Secukinumab vs Placebo: Percentage of Participants With GCA Who Had Sustained Remission Until Week 52 | Trial comparisons |
| Secukinumab vs Placebo: Percentage of Participants in Remission at Week 12 | Trial comparisons |
| Secukinumab vs Placebo: Percentage of Participants in Sustained Remission Until Week 28 | 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.
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/NCT03765788
GET https://conductscience.org/api/trials/v1/NCT03765788/results?page=2