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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04711902

Collaborator

(none)

Enrollment

Locations

Arms

26.1

Anticipated Duration (Months)

3.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Psoriatic Arthritis	Drug: Secukinumab (AIN457) Other: Secukinumab Placebo	Phase 3

Detailed 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

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

At Baseline, the patients fulfilling the inclusion criteria will be 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, the participants in Group 1 and Group 2 will be re-randomized: Group 1: Secukinumab dose level 2 s.c. regimen and placebo OR secukinumab dose level 2 every 4 weeks from Week 16 to Week 48. Group 2: Secukinumab dose level 2 s.c. regimen and placebo OR secukinumab dose level 2 every 4 weeks from Week 16 to Week 48.At Baseline, the patients fulfilling the inclusion criteria will be 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, the participants in Group 1 and Group 2 will be re-randomized:Group 1: Secukinumab dose level 2 s.c. regimen and placebo OR secukinumab dose level 2 every 4 weeks from Week 16 to Week 48. Group 2: Secukinumab dose level 2 s.c. regimen and placebo OR secukinumab dose level 2 every 4 weeks from Week 16 to Week 48.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

This is a double-blind randomized treatment trial. Participants, investigator staff, persons performing the assessments will remain blinded to the identity of the treatment from the time of randomization until database lock.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 24, 2021

Anticipated Primary Completion Date :

Jun 5, 2023

Anticipated Study Completion Date :

Aug 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 1 Arm 1 - Secukinumab Dose level 1	Drug: Secukinumab (AIN457) Biological Other Names: Secukinumab
Placebo Comparator: Arm 2 Arm 2 Secukinumab Placebo	Other: Secukinumab Placebo Matching placebo Other Names: Placebo
Active Comparator: Arm 3 Arm 3 Secukinumab Dose level 1 and Placebo	Drug: Secukinumab (AIN457) Biological Other Names: Secukinumab Other: Secukinumab Placebo Matching placebo Other Names: Placebo
Active Comparator: Arm 4 Arm 4 Secukinumab Dose level 2	Drug: Secukinumab (AIN457) Biological Other Names: Secukinumab

Outcome Measures

Primary Outcome Measures

ACR20 response at Week 16. [16 weeks]
to assess the efficacy of secukinumab relative to placebo at week 16 based on the proportion of participants achieving an ACR20 response

Secondary Outcome Measures

ACR50 response at week 16. [16 weeks]
To assess the effect of secukinumab versus placebo on the composite endpoint ACR50 response.
Change from BSL in DAS28-CRP at Week 16. [16 weeks]
To assess the effect of secukinumab versus placebo on change from BSL in DAS28-CRP
Change from BSL in PASDAS at Week 16. [16 weeks]
To assess the the effect of secukinumab versus placebo on change from Baseline in PASDAS
Change from BSL in SF36-PCS at Week 16. [16 weeks]
To assess the effect of secukinumab versus placebo on change from Baseline in SF-36 PCS
Change from BSL in HAQ-DI© at Week 16 [16 weeks]
To assess the effect of secukinumab versus placebo on change from Baseline in HAQ-DI

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Chongqing	Chongqing	China	400010
2	Novartis Investigative Site	Guang Zhou	Guang Dong Province	China	510120
3	Novartis Investigative Site	Zhuzhou	Hunan	China
4	Novartis Investigative Site	Baotou	Inner Mongolia	China	014010
5	Novartis Investigative Site	Hohhot	Inner Mongolia	China	10050
6	Novartis Investigative Site	Nanjing	Jiangsu	China	210008
7	Novartis Investigative Site	Nanchang	Jiangxi	China	330006
8	Novartis Investigative Site	Pingxiang	Jiangxi	China	337000
9	Novartis Investigative Site	Chengdu	Sichuan	China	610041
10	Novartis Investigative Site	Beijing		China	100730
11	Novartis Investigative Site	Jinan		China	250012
12	Novartis Investigative Site	Shanghai		China	200127

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novartis Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT04711902

Other Study ID Numbers:

CAIN457F2367

First Posted:

Jan 15, 2021

Last Update Posted:

Jun 10, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Novartis Pharmaceuticals

PsA, immune-mediated chronic inflammatory disease, spondylarthritis, SpA, inflammatory musculoskeletal disease, China bridging study

Additional relevant MeSH terms:

Arthritis

Arthritis, Psoriatic

Antibodies, Monoclonal

Study Results

No Results Posted as of Jun 10, 2022