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

Last updated: October 7, 2024
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Psoriasis And Psoriatic Disorders

Joint Injuries

Psoriatic Arthritis

Treatment

Secukinumab Placebo

AIN457

Clinical Study ID

NCT04711902
CAIN457F2367
  • Ages 18-99
  • All Genders

Study 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

Inclusion Criteria:

  • Participant must be able to understand and communicate with the investigator andcomply with the requirements of the study and must give a written, signed and datedinformed consent before any study assessment is performed.

  • Chinese male or non-pregnant, non-lactating Chinese female participants at least 18years 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 Psoriaticarthritis (PsA).

  • Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodiesnegative at screening.

  • Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or adocumented history of plaque psoriasis.

  • Participants on Methotrexate (MTX) must be on folic acid supplementation atrandomization.

  • Participants who are on a DMARD other than MTX must discontinue the DMARD 4 weeksprior to randomization visit except for leflunomide, which has to be discontinuedfor 8 weeks prior to randomization unless a cholestyramine washout has beenperformed.

Exclusion

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 targetinginterleukin- 17 (IL-17) or IL-17 receptor

  • Participants who have ever received biologic immunomodulating agents except forthose targeting Tumor necrosis factor alpha (TNFα).

  • Women of child-bearing potential, defined as all women physiologically capable ofbecoming pregnant, unless they are using effective contraception during the entirestudy (during the entire study).

Study Design

Total Participants: 41
Treatment Group(s): 2
Primary Treatment: Secukinumab Placebo
Phase: 3
Study Start date:
June 24, 2021
Estimated Completion Date:
March 10, 2023

Study Description

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.

A follow-up visit was done 12 weeks after last study treatment administration for all participants, regardless of whether they completed the entire study as planned or discontinued prematurely.

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, participants in Group 1 and Group 2 were to be re-randomized separately in a 1:1 ratio to receive secukinumab 150 mg or secukinumab 300 mg.

The duration of the entire treatment period was 52 weeks.

The primary objective was to demonstrate the treatment effect of secukinumab in Chinese subjects with active PsA by assessing American College of Rheumatology rresponse 20 (ACR20 response) rates at Week 16.

Connect with a study center

  • Novartis Investigative Site

    Chongqing, Chongqing 400010
    China

    Site Not Available

  • Novartis Investigative Site

    Guang Zhou, Guang Dong Province 510120
    China

    Site Not Available

  • Novartis Investigative Site

    Guangzhou, Guangdong 510515
    China

    Site Not Available

  • Novartis Investigative Site

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Novartis Investigative Site

    Zhuzhou, Hunan 412000
    China

    Site Not Available

  • Novartis Investigative Site

    Baotou, Inner Mongolia 014010
    China

    Site Not Available

  • Novartis Investigative Site

    Hohhot, Inner Mongolia 10050
    China

    Site Not Available

  • Novartis Investigative Site

    Nanjing, Jiangsu 210008
    China

    Site Not Available

  • Novartis Investigative Site

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • Novartis Investigative Site

    Pingxiang, Jiangxi 337000
    China

    Site Not Available

  • Novartis Investigative Site

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Novartis Investigative Site

    Urumqi, Xinjiang 830001
    China

    Site Not Available

  • Novartis Investigative Site

    Beijing, 100730
    China

    Site Not Available

  • Novartis Investigative Site

    Jinan, 250012
    China

    Site Not Available

  • Novartis Investigative Site

    Shanghai, 200127
    China

    Site Not Available

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