Study of Efficacy and Safety of Secukinumab in Chinese Subjects With Active PsA Compared to Placebo.
NCT ID: NCT04711902
Last Updated: 2024-10-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
41 participants
INTERVENTIONAL
2021-06-24
2023-03-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1
Participants received 150 mg dose (dose level 1) of Secukinumab
AIN457
Secukinumab 150 mg was supplied in 1.0 mL prefilled syringe, administered via subcutaneous injection
Arm 2
Participants received Placebo of the study drug.
Secukinumab Placebo
Secukinumab placebo was supplied in 1.0 mL prefilled syringe, administered via subcutaneous injection
Arm 3
Participants who received Placebo and switched to dose level 1 (150 mg) of secukinumab.
AIN457
Secukinumab 150 mg was supplied in 1.0 mL prefilled syringe, administered via subcutaneous injection
Secukinumab Placebo
Secukinumab placebo was supplied in 1.0 mL prefilled syringe, administered via subcutaneous injection
Arm 4
Participants who received Placebo and switched to dose level 2 (300 mg) of secukinumab.
AIN457
Secukinumab 150 mg was supplied in 1.0 mL prefilled syringe, administered via subcutaneous injection
Secukinumab Placebo
Secukinumab placebo was supplied in 1.0 mL prefilled syringe, administered via subcutaneous injection
Interventions
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AIN457
Secukinumab 150 mg was supplied in 1.0 mL prefilled syringe, administered via subcutaneous injection
Secukinumab Placebo
Secukinumab placebo was supplied in 1.0 mL prefilled syringe, administered via subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
99 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Chongqing, Chongqing Municipality, China
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Zhuzhou, Hunan, China
Novartis Investigative Site
Baotou, Inner Mongolia, China
Novartis Investigative Site
Hohhot, Inner Mongolia, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Nanchang, Jiangxi, China
Novartis Investigative Site
Pingxiang, Jiangxi, China
Novartis Investigative Site
Chengdu, Sichuan, China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Jinan, , China
Novartis Investigative Site
Shanghai, , China
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Plain Language Trial Summary is available on novctrd.com
Other Identifiers
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CAIN457F2367
Identifier Type: -
Identifier Source: org_study_id
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