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

Primary Purpose

Psoriatic Arthritis

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Secukinumab (AIN457)
Secukinumab Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriatic Arthritis focused on measuring PsA, immune-mediated chronic inflammatory disease, spondylarthritis, SpA, inflammatory musculoskeletal disease, China bridging study

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm Description

Arm 1 - Secukinumab Dose level 1

Arm 2 Secukinumab Placebo

Arm 3 Secukinumab Dose level 1 and Placebo

Arm 4 Secukinumab Dose level 2

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 14, 2021
Last Updated
April 26, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04711902
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 24, 2021 (Actual)
Primary Completion Date
June 2, 2022 (Actual)
Study Completion Date
March 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study was to assess the efficacy and safety of secukinumab in Chinese participants with active 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
Keywords
PsA, immune-mediated chronic inflammatory disease, spondylarthritis, SpA, inflammatory musculoskeletal disease, China bridging study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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, 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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
This was 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.
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
Arm 1 - Secukinumab Dose level 1
Arm Title
Arm 2
Arm Type
Placebo Comparator
Arm Description
Arm 2 Secukinumab Placebo
Arm Title
Arm 3
Arm Type
Active Comparator
Arm Description
Arm 3 Secukinumab Dose level 1 and Placebo
Arm Title
Arm 4
Arm Type
Active Comparator
Arm Description
Arm 4 Secukinumab Dose level 2
Intervention Type
Drug
Intervention Name(s)
Secukinumab (AIN457)
Other Intervention Name(s)
Secukinumab
Intervention Description
Biological
Intervention Type
Other
Intervention Name(s)
Secukinumab Placebo
Other Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
ACR20 response at Week 16.
Description
to assess the efficacy of secukinumab relative to placebo at week 16 based on the proportion of participants achieving an ACR20 response
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
ACR50 response at week 16.
Description
To assess the effect of secukinumab versus placebo on the composite endpoint ACR50 response.
Time Frame
16 weeks
Title
Change from BSL in DAS28-CRP at Week 16.
Description
To assess the effect of secukinumab versus placebo on change from BSL in DAS28-CRP
Time Frame
16 weeks
Title
Change from BSL in PASDAS at Week 16.
Description
To assess the the effect of secukinumab versus placebo on change from Baseline in PASDAS
Time Frame
16 weeks
Title
Change from BSL in SF36-PCS at Week 16.
Description
To assess the effect of secukinumab versus placebo on change from Baseline in SF-36 PCS
Time Frame
16 weeks
Title
Change from BSL in HAQ-DI© at Week 16
Description
To assess the effect of secukinumab versus placebo on change from Baseline in HAQ-DI
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
Novartis Investigative Site
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400010
Country
China
Facility Name
Novartis Investigative Site
City
Guang Zhou
State/Province
Guang Dong Province
ZIP/Postal Code
510120
Country
China
Facility Name
Novartis Investigative Site
City
Zhuzhou
State/Province
Hunan
ZIP/Postal Code
412000
Country
China
Facility Name
Novartis Investigative Site
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014010
Country
China
Facility Name
Novartis Investigative Site
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
10050
Country
China
Facility Name
Novartis Investigative Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
Novartis Investigative Site
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Novartis Investigative Site
City
Pingxiang
State/Province
Jiangxi
ZIP/Postal Code
337000
Country
China
Facility Name
Novartis Investigative Site
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Novartis Investigative Site
City
Jinan
ZIP/Postal Code
250012
Country
China
Facility Name
Novartis Investigative Site
City
Shanghai
ZIP/Postal Code
200127
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Learn more about this trial

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

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