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

Psoriatic Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04711902
• Other study ID #: CAIN457F2367
• Status: Completed
• Phase: Phase 3
• Start date: June 24, 2021
• Est. completion date: March 10, 2023

Study information

• Verified date: April 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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. At baseline, approximately 40 Chinese patients will be randomized.

A follow-up visit was 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 was 52 weeks. The primary objective was to demonstrate the treatment effect of secukinumab in Chinese subjects with active PsA by assessing ACR20 response rates at Week 16

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 10, 2023
• Est. primary completion date: June 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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 TNFa.

• 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).

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Drug:
• Secukinumab (AIN457)
Biological

Other:
• Secukinumab Placebo
Matching placebo

Locations

Country	Name	City	State
China	Novartis Investigative Site	Baotou	Inner Mongolia
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Chengdu	Sichuan
China	Novartis Investigative Site	Chongqing	Chongqing
China	Novartis Investigative Site	Guang Zhou	Guang Dong Province
China	Novartis Investigative Site	Hohhot	Inner Mongolia
China	Novartis Investigative Site	Jinan
China	Novartis Investigative Site	Nanchang	Jiangxi
China	Novartis Investigative Site	Nanjing	Jiangsu
China	Novartis Investigative Site	Pingxiang	Jiangxi
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Zhuzhou	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACR20 response at Week 16.	to assess the efficacy of secukinumab relative to placebo at week 16 based on the proportion of participants achieving an ACR20 response	16 weeks
Secondary	ACR50 response at week 16.	To assess the effect of secukinumab versus placebo on the composite endpoint ACR50 response.	16 weeks
Secondary	Change from BSL in DAS28-CRP at Week 16.	To assess the effect of secukinumab versus placebo on change from BSL in DAS28-CRP	16 weeks
Secondary	Change from BSL in PASDAS at Week 16.	To assess the the effect of secukinumab versus placebo on change from Baseline in PASDAS	16 weeks
Secondary	Change from BSL in SF36-PCS at Week 16.	To assess the effect of secukinumab versus placebo on change from Baseline in SF-36 PCS	16 weeks
Secondary	Change from BSL in HAQ-DI© at Week 16	To assess the effect of secukinumab versus placebo on change from Baseline in HAQ-DI	16 weeks