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

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

ClinicalTrials.gov Identifier: NCT04711902

Novartis Reference Number: CAIN457F2367

Last Update: Dec 03, 2021

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Psoriatic Arthritis
Phase 
Phase 3
Overall status 
Recruiting
Start date 
Jun 24, 2021
Completion date 
Aug 28, 2023
Gender 
All
Age(s)
18 Years - 99 Years (Adult, Older Adult)

Interventions

Drug
Secukinumab (AIN457)
Biological
Other
Secukinumab Placebo
Matching placebo
Drug
Secukinumab (AIN457)
Biological
Other
Secukinumab Placebo
Matching placebo
Drug
Secukinumab (AIN457)
Biological
Other
Secukinumab Placebo
Matching placebo

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 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 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).

Study Locations

China
Novartis Investigative Site
Recruiting
Chongqing, 400010
Chongqing
China
Novartis Investigative Site
Recruiting
Guang Zhou, 510120
Guang Dong Province
China
Novartis Investigative Site
Recruiting
Guangzhou, 510515
Guangdong
China
Novartis Investigative Site
Recruiting
Wuhan, 430030
Hubei
China
Novartis Investigative Site
Recruiting
Zhuzhou,
Hunan
China
Novartis Investigative Site
Recruiting
Baotou, 014010
Inner Mongolia
China
Novartis Investigative Site
Recruiting
Hohhot, 10050
Inner Mongolia
China
Novartis Investigative Site
Recruiting
Nanjing, 210008
Jiangsu
China
Novartis Investigative Site
Recruiting
Nanchang, 330006
Jiangxi
China
Novartis Investigative Site
Recruiting
Pingxiang, 337000
Jiangxi
China
Novartis Investigative Site
Recruiting
Chengdu, 610041
Sichuan
China
Novartis Investigative Site
Recruiting
Urumqi, 830001
Xinjiang
China
Novartis Investigative Site
Recruiting
Beijing, 100730
-
China
Novartis Investigative Site
Recruiting
Jinan, 250012
-
China
Novartis Investigative Site
Recruiting
Shanghai, 200127
-
China
Novartis Investigative Site
Recruiting
Chongqing, 400010
Chongqing
China
Novartis Investigative Site
Recruiting
Guang Zhou, 510120
Guang Dong Province
China
Novartis Investigative Site
Recruiting
Guangzhou, 510515
Guangdong
China
Novartis Investigative Site
Recruiting
Wuhan, 430030
Hubei
China
Novartis Investigative Site
Recruiting
Zhuzhou,
Hunan
China
Novartis Investigative Site
Recruiting
Baotou, 014010
Inner Mongolia
China
Novartis Investigative Site
Recruiting
Hohhot, 10050
Inner Mongolia
China
Novartis Investigative Site
Recruiting
Nanjing, 210008
Jiangsu
China
Novartis Investigative Site
Recruiting
Nanchang, 330006
Jiangxi
China
Novartis Investigative Site
Recruiting
Pingxiang, 337000
Jiangxi
China
Novartis Investigative Site
Recruiting
Chengdu, 610041
Sichuan
China
Novartis Investigative Site
Recruiting
Urumqi, 830001
Xinjiang
China
Novartis Investigative Site
Recruiting
Beijing, 100730
-
China
Novartis Investigative Site
Recruiting
Jinan, 250012
-
China
Novartis Investigative Site
Recruiting
Shanghai, 200127
-
China
Novartis Investigative Site
Recruiting
Chongqing, 400010
Chongqing
China
Novartis Investigative Site
Recruiting
Guang Zhou, 510120
Guang Dong Province
China
Novartis Investigative Site
Recruiting
Guangzhou, 510515
Guangdong
China
Novartis Investigative Site
Recruiting
Wuhan, 430030
Hubei
China
Novartis Investigative Site
Recruiting
Zhuzhou,
Hunan
China
Novartis Investigative Site
Recruiting
Baotou, 014010
Inner Mongolia
China
Novartis Investigative Site
Recruiting
Hohhot, 10050
Inner Mongolia
China
Novartis Investigative Site
Recruiting
Nanjing, 210008
Jiangsu
China
Novartis Investigative Site
Recruiting
Nanchang, 330006
Jiangxi
China
Novartis Investigative Site
Recruiting
Pingxiang, 337000
Jiangxi
China
Novartis Investigative Site
Recruiting
Chengdu, 610041
Sichuan
China
Novartis Investigative Site
Recruiting
Urumqi, 830001
Xinjiang
China
Novartis Investigative Site
Recruiting
Beijing, 100730
-
China
Novartis Investigative Site
Recruiting
Jinan, 250012
-
China
Novartis Investigative Site
Recruiting
Shanghai, 200127
-
China

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]