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

  • STATUS
    Recruiting
  • End date
    Aug 28, 2023
  • participants needed
    40
  • sponsor
    Novartis Pharmaceuticals
Updated on 27 August 2021
psoriasis
secukinumab
DMARD
dactylitis
leflunomide
folate supplementation
cholestyramine
plaque psoriasis
rheumatoid factor

Summary

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

Description

This study uses a randomized, double-blind, placebo-controlled, parallel-group design. A screening period running up to 10 weeks before randomization will be used to assess participant eligibility followed by 52 weeks of treatment. At baseline, approximately 40 Chinese patients will be randomized.

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

The total combined duration of treatment for this Phase III study is 52 weeks. The primary objective is to demonstrate the treatment effect of secukinumab in Chinese subjects with active PsA by assessing ACR20 response rates at Week 16

Details
Condition Psoriasis, PSORIATIC ARTHRITIS, Arthritis
Treatment Secukinumab (AIN457), Secukinumab Placebo
Clinical Study IdentifierNCT04711902
SponsorNovartis Pharmaceuticals
Last Modified on27 August 2021

Eligibility

Yes No Not Sure

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 TNF
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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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