NCT04711902

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

A Phase III Randomized, Double-blind, Placebo Controlled, Multicenter, Bridging Study of Subcutaneous Secukinumab, to Demonstrate Efficacy After Sixteen Weeks of Treatment and to Assess Safety, Tolerability and Long-term Efficacy Follow-up to One Year in Chinese Subjects With Active Psoriatic Arthritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to assess the efficacy and safety of secukinumab in Chinese participants with active Psoriatic arthritis (PsA ) compared to placebo.

Detailed description

This study used a randomized, double-blind, placebo-controlled, parallel-group design. A screening period running up to 10 weeks before randomization was used to assess participant eligibility followed by 52 weeks of treatment. A follow-up visit was done 12 weeks after last study treatment administration for all participants, regardless of whether they completed the entire study as planned or discontinued prematurely. At Baseline, the patients fulfilling the inclusion criteria were randomized to one of the following two groups. Group 1 : Secukinumab Dose level 1 s.c. at BSL, Week 1, 2, 3, 4, 8, and 12 Group 2 : Secukinumab Placebo s.c. at BSL, Week 1, 2, 3, 4, 8, and 12. At Week 16, participants in Group 1 and Group 2 were to be re-randomized separately in a 1:1 ratio to receive secukinumab 150 mg or secukinumab 300 mg. The duration of the entire treatment period was 52 weeks. The primary objective was to demonstrate the treatment effect of secukinumab in Chinese subjects with active PsA by assessing American College of Rheumatology rresponse 20 (ACR20 response) rates at Week 16.

Conditions

• Psoriatic Arthritis

Interventions

Type	Name	Description
DRUG	AIN457	Secukinumab 150 mg was supplied in 1.0 mL prefilled syringe, administered via subcutaneous injection
OTHER	Secukinumab Placebo	Secukinumab placebo was supplied in 1.0 mL prefilled syringe, administered via subcutaneous injection

Timeline

• Start date: 2021-06-24
• Primary completion: 2022-06-02
• Completion: 2023-03-10
• First posted: 2021-01-15
• Last updated: 2024-10-09
• Results posted: 2024-07-19

Locations

12 sites across 1 country: China