Phase 3
N=41
Study of Efficacy and Safety of Secukinumab in Chinese Subjects With Active PsA Compared to Placebo.
Psoriatic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT04711902 ↗Enrolled (actual)
41
Serious AEs
1.8%
Results posted
Jul 2024
Primary outcome: Primary: ACR20 Response at Week 16 — 14; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- AIN457 (Drug); Secukinumab Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ACR20 Response at Week 16 |
14; 6 | — |
| SECONDARY ACR50 Response at Week 16 |
3; 1 | — |
| SECONDARY Change From Baseline in DAS28-CRP Scores Using Mixed Model Repeated Scores (MMRM) at Week 16 |
-1.47; -0.37 | — |
| SECONDARY Change From Baseline in PASDAS Scores Using MMRM at Week 16 |
-2.20; -0.55 | — |
| SECONDARY Change From Baseline in SF36-PCS Scores Using MMRM at Week 16 |
4.28; 0.08 | — |
| SECONDARY Change From Baseline in HAQ-DI Scores Using MMRM at Week 16 |
-0.31; 0.09 | — |
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.
Eligibility 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 Classification of Psoriatic Arthritis (CASPAR) criteria and with symptoms for at least 6 months with moderate to severe Psoriatic arthritis (PsA).
- Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (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 Methotrexate (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 Tumor necrosis factor alpha (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).
Data sourced from ClinicalTrials.gov (NCT04711902). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.