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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04711902
Recruitment Status : Active, not recruiting
First Posted : January 15, 2021
Last Update Posted : June 10, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

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Study Type : Interventional  (Clinical Trial)
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.

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 : June 24, 2021
Estimated Primary Completion Date : June 5, 2023
Estimated Study Completion Date : August 28, 2023


Arm Intervention/treatment
Active Comparator: Arm 1
Arm 1 - Secukinumab Dose level 1
Drug: Secukinumab (AIN457)
Biological
Other Name: Secukinumab

Placebo Comparator: Arm 2
Arm 2 Secukinumab Placebo
Other: Secukinumab Placebo
Matching placebo
Other Name: Placebo

Active Comparator: Arm 3
Arm 3 Secukinumab Dose level 1 and Placebo
Drug: Secukinumab (AIN457)
Biological
Other Name: Secukinumab

Other: Secukinumab Placebo
Matching placebo
Other Name: Placebo

Active Comparator: Arm 4
Arm 4 Secukinumab Dose level 2
Drug: Secukinumab (AIN457)
Biological
Other Name: Secukinumab




Primary Outcome Measures :
  1. ACR20 response at Week 16. [ Time Frame: 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 :
  1. ACR50 response at week 16. [ Time Frame: 16 weeks ]
    To assess the effect of secukinumab versus placebo on the composite endpoint ACR50 response.

  2. Change from BSL in DAS28-CRP at Week 16. [ Time Frame: 16 weeks ]
    To assess the effect of secukinumab versus placebo on change from BSL in DAS28-CRP

  3. Change from BSL in PASDAS at Week 16. [ Time Frame: 16 weeks ]
    To assess the the effect of secukinumab versus placebo on change from Baseline in PASDAS

  4. Change from BSL in SF36-PCS at Week 16. [ Time Frame: 16 weeks ]
    To assess the effect of secukinumab versus placebo on change from Baseline in SF-36 PCS

  5. Change from BSL in HAQ-DI© at Week 16 [ Time Frame: 16 weeks ]
    To assess the effect of secukinumab versus placebo on change from Baseline in HAQ-DI



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04711902


Locations
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China, Chongqing
Novartis Investigative Site
Chongqing, Chongqing, China, 400010
China, Guang Dong Province
Novartis Investigative Site
Guang Zhou, Guang Dong Province, China, 510120
China, Hunan
Novartis Investigative Site
Zhuzhou, Hunan, China
China, Inner Mongolia
Novartis Investigative Site
Baotou, Inner Mongolia, China, 014010
Novartis Investigative Site
Hohhot, Inner Mongolia, China, 10050
China, Jiangsu
Novartis Investigative Site
Nanjing, Jiangsu, China, 210008
China, Jiangxi
Novartis Investigative Site
Nanchang, Jiangxi, China, 330006
Novartis Investigative Site
Pingxiang, Jiangxi, China, 337000
China, Sichuan
Novartis Investigative Site
Chengdu, Sichuan, China, 610041
China
Novartis Investigative Site
Beijing, China, 100730
Novartis Investigative Site
Jinan, China, 250012
Novartis Investigative Site
Shanghai, China, 200127
Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04711902    
Other Study ID Numbers: CAIN457F2367
First Posted: January 15, 2021    Key Record Dates
Last Update Posted: June 10, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
PsA, immune-mediated chronic inflammatory disease, spondylarthritis, SpA, inflammatory musculoskeletal disease, China bridging study
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs