Trial Outcomes & Findings for Study of Efficacy and Safety of Secukinumab in Chinese Subjects With Active PsA Compared to Placebo. (NCT NCT04711902)

NCT ID: NCT04711902

Last Updated: 2024-10-09

Results Overview

Assessed the efficacy of secukinumab relative to placebo at week 16 using Non-responder imputation (NRI) and based on the percentage of participants achieving an ACR20 response (ACR = American College of Rheumatology). ACR20 response criteria is response ≥ 20% improvement based on: Swollen Joint Count (SJC)/Tender Joint Count (TJC), Patient's global assessment of disease activity (PaGA) (Visual Analog Scale (VAS)), Physician's global assessment of disease activity (PhGA) (VAS), Patient's assessment of PsA pain intensity (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI), and High-sensitivity C-reactive protein (hsCRP) or Erythrocyte sedimentation rate (ESR).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

41 participants

Primary outcome timeframe

16 weeks

Results posted on

2024-10-09

Participant Flow

In the 1st 16 weeks of study, the 41 participants enrolled were randomized to 2 groups: 1 group received secukinumab 150 mg \& the other received placebo. At week 16, the participants were re-randomized within each group for a total of 4 groups. Within the secukinumab group, 1 group continued to receive secukinumab 150 mg while the other half received secukinumab 300 mg. In the Placebo group, 1 group switched to secukinumab 150 mg while the other half switched to secukinumab 300 mg.

This study was conducted in 12 centers in China.

Participant milestones

Participant milestones
Measure	Secukinumab 150 mg (Group 1) Participants received 150 mg dose (dose level 1) of Secukinumab	Placebo of Study Drug (Group 2) Participants received Placebo of the study drug	Secukinumab 150 mg to Secukinumab 150 mg (2nd Randomization) Participants who had previously received Secukinumab 150 mg dose (dose level 1) continued receiving 150 mg dose (dose level 1) of Secukinumab	Secukinumab 150 mg to Secukinumab 300 mg (2nd Randomization) Participants who had previously received Secukinumab 150 mg dose (dose level 1) now received 300 mg dose (dose level 2) of Secukinumab	Placebo to Secukinumab 150 mg (2nd Randomization) Participants who had previously received Placebo switched to Secukinumab 150 mg (dose level 1)	Placebo to Secukinumab 300 mg (2nd Randomization) Participants who had previously received Placebo switched to Secukinumab 300 mg (dose level 2)
Treatment Period 1 (1st 16 Weeks) STARTED	20	21	0	0	0	0
Treatment Period 1 (1st 16 Weeks) COMPLETED	20	21	0	0	0	0
Treatment Period 1 (1st 16 Weeks) NOT COMPLETED	0	0	0	0	0	0
Treatment Period 2 (From Week 16) STARTED	0	0	10	10	10	11
Treatment Period 2 (From Week 16) Discont. From Treatment Before Week 52	0	0	0	0	1	0
Treatment Period 2 (From Week 16) Completed Study Treatment	0	0	10	10	9	11
Treatment Period 2 (From Week 16) COMPLETED	0	0	8	10	10	11
Treatment Period 2 (From Week 16) NOT COMPLETED	0	0	2	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Secukinumab 150 mg (Group 1) Participants received 150 mg dose (dose level 1) of Secukinumab	Placebo of Study Drug (Group 2) Participants received Placebo of the study drug	Secukinumab 150 mg to Secukinumab 150 mg (2nd Randomization) Participants who had previously received Secukinumab 150 mg dose (dose level 1) continued receiving 150 mg dose (dose level 1) of Secukinumab	Secukinumab 150 mg to Secukinumab 300 mg (2nd Randomization) Participants who had previously received Secukinumab 150 mg dose (dose level 1) now received 300 mg dose (dose level 2) of Secukinumab	Placebo to Secukinumab 150 mg (2nd Randomization) Participants who had previously received Placebo switched to Secukinumab 150 mg (dose level 1)	Placebo to Secukinumab 300 mg (2nd Randomization) Participants who had previously received Placebo switched to Secukinumab 300 mg (dose level 2)
Treatment Period 2 (From Week 16) Participant decision	0	0	2	0	0	0

Baseline Characteristics

Study of Efficacy and Safety of Secukinumab in Chinese Subjects With Active PsA Compared to Placebo.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Secukinumab 150 mg (Group 1) n=20 Participants Participants received 150 mg dose (dose level 1) of Secukinumab	Placebo of Study Drug (Group 2) n=21 Participants Participants received Placebo of the study drug	Total n=41 Participants Total of all reporting groups
Age, Continuous	42.4 years STANDARD_DEVIATION 9.70 • n=5 Participants	45.7 years STANDARD_DEVIATION 10.46 • n=7 Participants	44.0 years STANDARD_DEVIATION 10.11 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	5 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	16 Participants n=7 Participants	23 Participants n=5 Participants
Race/Ethnicity, Customized Chinese	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: Full Analysis Set (FAS): All participants from the randomized set to whom study treatment had been assigned.

Outcome measures

Outcome measures
Measure	Secukinumab 150 mg (Group 1) n=20 Participants Participants received 150 mg dose (dose level 1) of Secukinumab	Placebo of Study Drug (Group 2) n=21 Participants Participants received Placebo of the study drug
ACR20 Response at Week 16	14 Participants	6 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Full Analysis Set (FAS): All participants from the randomized set to whom study treatment had been assigned.

To assess the effect of secukinumab versus placebo on the composite endpoint ACR50 response and based on the percentage of participants achieving an ACR50 response at Week 16 using NRI. ACR50 response criteria is response ≥ 50% improvement based on: Swollen Joint Count (SJC)/Tender Joint Count (TJC), Patient's global assessment of disease activity (PaGA) (VAS), Physician's global assessment of disease activity (PhGA) (VAS), Patient's assessment of PsA pain intensity (VAS), HAQ-DI, and hsCRP or ESR.

Outcome measures

Outcome measures
Measure	Secukinumab 150 mg (Group 1) n=20 Participants Participants received 150 mg dose (dose level 1) of Secukinumab	Placebo of Study Drug (Group 2) n=21 Participants Participants received Placebo of the study drug
ACR50 Response at Week 16	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Full Analysis Set (FAS): All participants from the randomized set to whom study treatment had been assigned. This is subset of participants from the randomized set to whom study treatment had been assigned and had a valid value of the outcome measure.

To assess the effect of secukinumab versus placebo on change from BSL in DAS28-CRP. The assessment is based on the reduction in DAS28-CRP score. The DAS28 is a measure of disease activity based on Swollen and Tender Joint Counts, ESR or CRP and the Patient Global Assessment of Disease Activity. The range of DAS28 score is 0-10. Higher score means more active disease. Negative change from baseline indicates a favorable outcome.

Outcome measures

Outcome measures
Measure	Secukinumab 150 mg (Group 1) n=18 Participants Participants received 150 mg dose (dose level 1) of Secukinumab	Placebo of Study Drug (Group 2) n=20 Participants Participants received Placebo of the study drug
Change From Baseline in DAS28-CRP Scores Using Mixed Model Repeated Scores (MMRM) at Week 16	-1.47 scores on a scale Standard Error 0.206	-0.37 scores on a scale Standard Error 0.200

SECONDARY outcome

Timeframe: 16 weeks

To assess the the effect of secukinumab versus placebo on change from Baseline in PASDAS. Assessment was based on reduction in PASDAS score. PASDAS is a measure of disease activity based on Patient reported measures (excluding mental component score (MCS) of the medical outcomes survey Short Form-36 (SF-36-PCS)), skin, peripheral joint counts (Tender and Swollen joint counts), Dactylitis (LDI), Enthesitis (LEI), acute phase response (CRP) and Patient \& Physician global VAS scores. The range of PASDAS is 0-10. Higher score means more active disease. Negative change from baseline indicates a favorable outcome.

Outcome measures

Outcome measures
Measure	Secukinumab 150 mg (Group 1) n=18 Participants Participants received 150 mg dose (dose level 1) of Secukinumab	Placebo of Study Drug (Group 2) n=20 Participants Participants received Placebo of the study drug
Change From Baseline in PASDAS Scores Using MMRM at Week 16	-2.20 scores on a scale Standard Error 0.245	-0.55 scores on a scale Standard Error 0.237

SECONDARY outcome

Timeframe: 16 weeks

To assess the effect of secukinumab versus placebo on change from Baseline in SF-36 PCS. The SF-36 is a widely used and extensively studied instrument to measure HRQoL among healthy participants and participants with acute and chronic conditions. Two overall summary scores, the Physical Component Score (PCS) and the Mental Component Score (MCS) also can be computed. SF36-PCS was used in this study. The range of SF36-PCS score is 0-100. Higher score means better health status. Negative change from baseline indicates a unfavorable outcome.

Outcome measures

Outcome measures
Measure	Secukinumab 150 mg (Group 1) n=19 Participants Participants received 150 mg dose (dose level 1) of Secukinumab	Placebo of Study Drug (Group 2) n=21 Participants Participants received Placebo of the study drug
Change From Baseline in SF36-PCS Scores Using MMRM at Week 16	4.28 scores on a scale Standard Error 1.154	0.08 scores on a scale Standard Error 1.113

SECONDARY outcome

Timeframe: 16 weeks

To assess the effect of secukinumab versus placebo on change from Baseline in HAQ-DI. Assessment was based on improvement in HAQ-DI PCS scores. The HAQ-DI© is one of the most widely used measures to assess the long-term influence of chronic disease on a participant's level of functional ability and activity restriction, and calculated based on HAQ-DI questionnaire. There are 20 questions in eight categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. The range of score is 0-3. Higher score means more severe disability. Negative change from baseline indicates a favorable outcome.

Outcome measures

Outcome measures
Measure	Secukinumab 150 mg (Group 1) n=19 Participants Participants received 150 mg dose (dose level 1) of Secukinumab	Placebo of Study Drug (Group 2) n=21 Participants Participants received Placebo of the study drug
Change From Baseline in HAQ-DI Scores Using MMRM at Week 16	-0.31 scores on a scale Standard Error 0.065	0.09 scores on a scale Standard Error 0.063

Adverse Events

Any AIN457 150 mg

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Any AIN457 300 mg

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Any AIN457

Serious events: 1 serious events

Other events: 37 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Any AIN457 150 mg n=30 participants at risk Participants who received Secukinumab 150 mg dose (dose level 1) at any point during the trial.	Any AIN457 300 mg n=21 participants at risk Participants who received Secukinumab 300 mg dose (dose level 2) at any point during the trial.	Any AIN457 n=41 participants at risk Participants who received Secukinumab, regardless of dose, at any point during the trial.	Placebo n=21 participants at risk Participants who received Placebo at any point during the trial.
Eye disorders Cataract	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 52 weeks. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	4.8% 1/21 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 52 weeks. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	2.4% 1/41 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 52 weeks. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/21 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 52 weeks. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.
Eye disorders Epiretinal membrane	0.00% 0/30 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 52 weeks. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	4.8% 1/21 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 52 weeks. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	2.4% 1/41 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 52 weeks. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.	0.00% 0/21 • Adverse events were collected from first dose of study treatment to 30 days after last dose of study medication (on-treatment), up to approx. 52 weeks. Any sign or symptom that occurs during the conduct of the trial and safety follow-up. Deaths in the post treatment survival follow-up are not considered Adverse Events. The total number at risk in the post treatment survival includes patients that entered the post treatment survival follow-up period.

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
Publication restrictions are in place

Restriction type: OTHER