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

Study Overview
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Brief Summary
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The purpose of this study was to assess the efficacy and safety of secukinumab in Chinese participants with active PsA compared to placebo

Detailed Description
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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. At baseline, approximately 40 Chinese patients will be randomized. A follow-up visit was done 12 weeks after last study treatment administration for all participants, regardless of whether they complete the entire study as planned or discontinue prematurely. The total combined duration of treatment for this Phase III study was 52 weeks. The primary objective was to demonstrate the treatment effect of secukinumab in Chinese subjects with active PsA by assessing ACR20 response rates at Week 16

Official Title
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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

Conditions
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Psoriatic Arthritis

Intervention / Treatment
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* Drug: Secukinumab (AIN457)
* Other: Secukinumab Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed. Chinese male or non-pregnant, non-lactating Chinese female participants at least 18 years of age. Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at BSL ≥3 tender joints out of 78 and ≥3 swollen joints out of 76 (dactylitis of a digit counts as one joint each). Rheumatoid factor (RF) and anti-CCP antibodies negative at screening. Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or a documented history of plaque psoriasis. Participants on MTX must be on folic acid supplementation at randomization. Participants who are on a DMARD other than MTX must discontinue the DMARD 4 weeks prior to randomization visit except for leflunomide, which has to be discontinued for 8 weeks prior to randomization unless a cholestyramine washout has been performed. Exclusion Criteria: Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician Participants taking high potency opioid analgesics (e.g., methadone, hydromorphone, morphine). Previous exposure to secukinumab or other biologic drug directly targeting interleukin- 17 (IL-17) or IL-17 receptor Participants who have ever received biologic immunomodulating agents except for those targeting TNFα. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective contraception during the entire study (during the entire study).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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, the participants in Group 1 and Group 2 will be re-randomized: Group 1: Secukinumab dose level 2 s.c. regimen and placebo OR secukinumab dose level 2 every 4 weeks from Week 16 to Week 48. Group 2: Secukinumab dose level 2 s.c. regimen and placebo OR secukinumab dose level 2 every 4 weeks from Week 16 to Week 48.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>Arm 1 - Secukinumab Dose level 1 | Drug: Secukinumab (AIN457)<br>* Biological<br>* Other names: Secukinumab;|
| Placebo Comparator: Arm 2<br>Arm 2 Secukinumab Placebo | Other: Secukinumab Placebo<br>* Matching placebo<br>* Other names: Placebo;|
| Active Comparator: Arm 3<br>Arm 3 Secukinumab Dose level 1 and Placebo | Drug: Secukinumab (AIN457)<br>* Biological<br>* Other names: Secukinumab;Other: Secukinumab Placebo<br>* Matching placebo<br>* Other names: Placebo;|
| Active Comparator: Arm 4<br>Arm 4 Secukinumab Dose level 2 | Drug: Secukinumab (AIN457)<br>* Biological<br>* Other names: Secukinumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR20 response at Week 16. | to assess the efficacy of secukinumab relative to placebo at week 16 based on the proportion of participants achieving an ACR20 response | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR50 response at week 16. | To assess the effect of secukinumab versus placebo on the composite endpoint ACR50 response. | 16 weeks | 
| Change from BSL in DAS28-CRP at Week 16. | To assess the effect of secukinumab versus placebo on change from BSL in DAS28-CRP | 16 weeks | 
| Change from BSL in PASDAS at Week 16. | To assess the the effect of secukinumab versus placebo on change from Baseline in PASDAS | 16 weeks | 
| Change from BSL in SF36-PCS at Week 16. | To assess the effect of secukinumab versus placebo on change from Baseline in SF-36 PCS | 16 weeks | 
| Change from BSL in HAQ-DI© at Week 16 | To assess the effect of secukinumab versus placebo on change from Baseline in HAQ-DI | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PsA, immune-mediated chronic inflammatory disease, spondylarthritis, SpA, inflammatory musculoskeletal disease, China bridging study