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Phase 3 N=41 Randomized Quadruple-blind Treatment

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

Psoriatic Arthritis

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

OutcomeResultp-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).
View full record on ClinicalTrials.gov →

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.

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