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

NCT04711902 | Completed Phase 3 Results

• 1 other identifier: CAIN457F2367
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Psoriatic Arthritis

Keywords

PsA; immune-mediated chronic inflammatory disease; spondylarthritis; SpA; inflammatory musculoskeletal disease; China bridging study; AIN457; secukinumab

Outcome Measures

Primary Outcomes (1)

• ACR20 Response at Week 16

  Assessed the efficacy of secukinumab relative to placebo at week 16 using Non-responder imputation (NRI) and based on the percentage of participants achieving an ACR20 response (ACR = American College of Rheumatology). ACR20 response criteria is response ≥ 20% improvement based on: Swollen Joint Count (SJC)/Tender Joint Count (TJC), Patient's global assessment of disease activity (PaGA) (Visual Analog Scale (VAS)), Physician's global assessment of disease activity (PhGA) (VAS), Patient's assessment of PsA pain intensity (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI), and High-sensitivity C-reactive protein (hsCRP) or Erythrocyte sedimentation rate (ESR).

  16 weeks

Secondary Outcomes (5)

• ACR50 Response at Week 16

  16 weeks

• Change From Baseline in DAS28-CRP Scores Using Mixed Model Repeated Scores (MMRM) at Week 16

  16 weeks

• Change From Baseline in PASDAS Scores Using MMRM at Week 16

  16 weeks

• Change From Baseline in SF36-PCS Scores Using MMRM at Week 16

  16 weeks

• Change From Baseline in HAQ-DI Scores Using MMRM at Week 16

  16 weeks

Study Arms (4)

Arm 1

EXPERIMENTAL

Participants received 150 mg dose (dose level 1) of Secukinumab

Drug: AIN457

Arm 2

PLACEBO COMPARATOR

Participants received Placebo of the study drug.

Other: Secukinumab Placebo

Arm 3

ACTIVE COMPARATOR

Participants who received Placebo and switched to dose level 1 (150 mg) of secukinumab.

Drug: AIN457; Other: Secukinumab Placebo

Arm 4

ACTIVE COMPARATOR

Participants who received Placebo and switched to dose level 2 (300 mg) of secukinumab.

Drug: AIN457; Other: Secukinumab Placebo

Interventions

AIN457 DRUG

Secukinumab 150 mg was supplied in 1.0 mL prefilled syringe, administered via subcutaneous injection

Also known as: Secukinumab

Arm 1; Arm 3; Arm 4

Secukinumab Placebo OTHER

Secukinumab placebo was supplied in 1.0 mL prefilled syringe, administered via subcutaneous injection

Arm 2; Arm 3; Arm 4

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (12)

Novartis Investigative Site

Chongqing, Chongqing Municipality, 400010, China

Location

Novartis Investigative Site

Guangzhou, Guangdong, 510120, China

Location

Novartis Investigative Site

Zhuzhou, Hunan, 412000, China

Location

Novartis Investigative Site

Baotou, Inner Mongolia, 014010, China

Location

Novartis Investigative Site

Hohhot, Inner Mongolia, 10050, China

Location

Novartis Investigative Site

Nanjing, Jiangsu, 210008, China

Location

Novartis Investigative Site

Nanchang, Jiangxi, 330006, China

Location

Novartis Investigative Site

Pingxiang, Jiangxi, 337000, China

Location

Novartis Investigative Site

Chengdu, Sichuan, 610041, China

Location

Novartis Investigative Site

Beijing, 100730, China

Location

Novartis Investigative Site

Jinan, 250012, China

Location

Novartis Investigative Site

Shanghai, 200127, China

Location

Related Links

• A Plain Language Trial Summary is available on novctrd.com

MeSH Terms

Conditions

Arthritis, Psoriatic; Spondylarthritis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 15, 2021
• Study Start: June 24, 2021
• Primary Completion: June 2, 2022
• Study Completion: March 10, 2023
• Last Updated: October 9, 2024
• Results First Posted: July 19, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (12)