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

• Status: Recruiting
• Trial end date: 2023-08-28
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy and safety of secukinumab in Chinese participants with active PsA compared to placebo

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antibodies, Monoclonal

Criteria

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).