Study to Demonstrate the Efficacy and Safety of Secukinumab up to 224 Weeks in Subjects With Active Peripheral Spondyloarthritis (pSpA).

NCT05206591 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: CAIN457X12301
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to investigate the efficacy and safety of subcutaneous (s.c) secukinumab in comparison with placebo for participants with two subtypes of active pSpA i.e. undifferentiated pSpA and chronic reactive arthritis, and with an inadequate response to conventional therapy despite current or previous Non-steroidal Anti Inflammatory Drugs (NSAIDs) and/or csDMARDs. Additionally, the study aims to evaluate efficacy and safety of continuing versus withdrawing secukinumab therapy in maintaining remission in the study population.

Conditions

Active Peripheral Spondyloarthritis (pSpA)

Keywords

secukinumab, active peripheral spondyloarthritis (pSpA)

Outcome Measures

Primary Outcomes (1)

• Modified Peripheral SpondyloArthritis Response Criteria (mPSpARC)

  To demonstrate the superiority of secukinumab compared to placebo based on Modified Peripheral SpondyloArthritis Response Criteria mPSpARC40

  Week 16

Study Arms (2)

Secukinumab

EXPERIMENTAL

Secukinumab 300 mg s.c

Biological: Secukinumab

Placebo

PLACEBO COMPARATOR

Placebo s.c.

Other: Placebo

Interventions

Secukinumab BIOLOGICAL

Secukinumab 300 s.c.

Secukinumab

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent must be obtained prior to participation in the study.
• Participant must be able to understand and communicate with the investigator and comply with the requirements of the study.
• Male or non-pregnant, non-lactating female participants at least 18 years of age.
• Participant meets ASAS criteria for classification of pSpA:
• Participant must have current arthritis (asymmetric or predominantly in the lower limbs) or enthesitis (except for enthesitis only along the spine
• , sacroiliac joints and/or chest wall) or dactylitis. AND at least one of the following SpA features:
• Anterior uveitis in past confirmed by a qualified medical professional (participants with current ongoing uveitis are excluded from participation in the study)
• Evidence of preceding infection (acute diarrhea or non-gonococcal urethritis or cervicitis 1 month before arthritis)
• HLA-B27 positivity
• Sacroiliitis on imaging; based on prior magnetic resonance imaging (MRI) or X-ray OR at least 2 of the following SpA features:
• Arthritis (past or present diagnosis), adequately documented and identified, or diagnosed by a qualified medical professional
• Enthesitis (any location, past or present diagnosis), adequately documented and identified, or diagnosed by a qualified medical professional
• Dactylitis (past or present diagnosis) adequately documented and identified, or diagnosed by a qualified medical professional
• Inflammatory back pain (past or present) Note: If there is concurrent inflammatory back pain it must be \< 2 on NRS score for total back pain \& nocturnal back pain (score 0-10) and the peripheral symptomatology of pSpA must be the predominant symptoms at study entry, based on the investigator's judgment at baseline.
• Family history for SpA.

You may not qualify if:

• Current or previous diagnosis of :
• Psoriasis (PsO) and/or nail changes consistent with PsO diagnosed by a qualified medical professional
• PsA diagnosed by a qualified medical professional
• Inflammatory bowel disease (IBD) diagnosed by a qualified medical professional
• axSpA (AS or nr-axSpA) diagnosed by a qualified medical professional
• Meets ASAS axSpA criteria as manifested by ALL of:
• a. Inflammatory back pain for at least 3 months b. Onset before 45 years of age c.
• Sacroiliitis on MRI with ≥ 1 SpA feature OR HLA-B-27 positive with ≥2 SpA features
• Score of ≥2 on numerical rating scale (NRS)-score for total back pain and nocturnal back pain (score 0-10)
• History of a confirmed diagnosis of any inflammatory joint disorder other than pSpA (e.g., rheumatoid arthritis, gouty arthritis, other crystalline arthritis, systemic lupus erythematosus, or any arthritis with onset prior to age 16 years such as juvenile idiopathic arthritis).
• Prior exposure to TNF-i's or other biologic immunomodulating agents, investigational or approved
• Active ongoing inflammatory diseases other than pSpA that might confound the evaluation of the benefit of secukinumab therapy (e.g., uveitis).
• Current or previous diagnosis of fibromyalgia by a qualified medical professional
• Diagnosis of synovitis associated with primary osteoarthritis
• Diagnosis of septic arthritis, sarcoidosis, seronegative RA, or erosive osteoarthritis

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Interventions

secukinumab

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 25, 2022
• Study Start: August 16, 2022
• Primary Completion (Estimated): March 20, 2028
• Study Completion (Estimated): June 12, 2028
• Last Updated: January 9, 2023

Record last verified: 2023-01