Clinical trial NCT04711902: Study of Efficacy and Safety of Secukinumab in Chinese Subjects With Active PsA Compared to Placebo.
Official title: A Phase III Randomized, Double-blind, Placebo Controlled, Multicenter, Bridging Study of Subcutaneous Secukinumab, to Demonstrate Efficacy After Sixteen Weeks of Treatment and to Assess Safety, Tolerability and Long-term Efficacy Follow-up to One Year in Chinese Subjects With Active Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriatic Arthritis
Keywords: PsA
immune-mediated chronic inflammatory disease
spondylarthritis
SpA
inflammatory musculoskeletal disease
China bridging study
AIN457
secukinumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-01-15
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

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).

Primary outcomes:
measure: ACR20 Response at Week 16
timeFrame: 16 weeks
Secondary outcomes:
measure: ACR50 Response at Week 16
timeFrame: 16 weeks
measure: Change From Baseline in DAS28-CRP Scores Using Mixed Model Repeated Scores (MMRM) at Week 16
timeFrame: 16 weeks
measure: Change From Baseline in PASDAS Scores Using MMRM at Week 16
timeFrame: 16 weeks
measure: Change From Baseline in SF36-PCS Scores Using MMRM at Week 16
timeFrame: 16 weeks
measure: Change From Baseline in HAQ-DI Scores Using MMRM at Week 16
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Novartis Investigative Site
state: Chongqing
city: Guang Zhou
country: China
facility: Novartis Investigative Site
state: Guang Dong Province
city: Zhuzhou
country: China
facility: Novartis Investigative Site
state: Hunan
city: Baotou
country: China
facility: Novartis Investigative Site
state: Inner Mongolia
city: Hohhot
country: China
facility: Novartis Investigative Site
state: Inner Mongolia
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Nanchang
country: China
facility: Novartis Investigative Site
state: Jiangxi
city: Pingxiang
country: China
facility: Novartis Investigative Site
state: Jiangxi
city: Chengdu
country: China
facility: Novartis Investigative Site
state: Sichuan
city: Beijing
country: China
facility: Novartis Investigative Site
city: Jinan
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: