Study of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing Spondylitis

NCT02750592 | Completed Phase 3 Results

• 1 other identifier: CAIN457H1301
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this study was to assess the clinical efficacy, safety and tolerability of secukinumab subcutaneous injections up to 52 weeks in Japanese patients with active AS despite current or previous non-steroidal anti-inflammatory drugs (NSAIDs) and/or anti-tumor necrosis factor (TNF) α therapy. Efficacy and safety data were used to support the registration of secukinumab in Japan for the treatment of active AS.

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing Spondylitis; secukinumab; AIN457H; SpondyloArthritis

Outcome Measures

Primary Outcomes (1)

• Assessment of SpondyloArthritis International Society 20 Response (ASAS20)

  This table is ASAS20 response using non-responder imputation for FAS It assesses the efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline in Japanese patients with active AS based on the proportion of patients achieving an ASAS (Assessment of SpondyloArthritis International Society criteria) 20 response. The ASAS Response Criteria (ASAS 20) is defined as an improvement of ≥ 20% and ≥ 1 unit on a scale of 10 in at least three of the four main domains and no worsening of ≥ 20% and ≥ 1 unit on a scale of 10 in the remaining domain

  week 16

Secondary Outcomes (15)

• ASAS 40 Response Rate With Non-responder Imputation (NRI)

  Week 16

• Bath Ankylosing Spondylitis Disease Activity (BASDAI) 50 Response Rate

  Week 16

• Change in High Sensitivity C-Reactive Protein (hsCRP)

  baseline, Week 16

• Number of Participants With ASAS 5/6 Response Criteria

  Week 16

• Mean Change From Baseline in BASDAI From Baseline

  Baseline, week 16

Study Arms (1)

secukinumab 150mg

EXPERIMENTAL

A screening (SCR) epoch running 4-10 weeks before baseline (BSL) was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consist of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 follows a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinue prematurely.

Drug: Secukinumab 150 mg provided in 1.0 mL pre-filled syringes (PFSs) for sc injection.

Interventions

Secukinumab 150 mg provided in 1.0 mL pre-filled syringes (PFSs) for sc injection. DRUG

Baseline, 1, 2, 3, 4 week. After 4 week, administered every 4 weeks.

secukinumab 150mg

Eligibility Criteria

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

You may qualify if:

• Diagnosis of moderate to severe AS with prior documented radiologic evidence (x-ray or radiologist's report) fulfilling the Modified New York criteria for AS with active AS assessed by BASDAI ≥ 4 (0-10) and spinal pain as measured by VAS≥ 4 cm (BASDAI question #2) at Baseline
• Patients should have been on NSAIDs at the highest recommended dose for at least 3 months prior to baseline with an inadequate response or failure to respond, or less than 3 months if therapy had to be withdrawn due to intolerance, toxicity or contraindications
• Patients who have been on a TNFα inhibitor (not more than one) must have experienced an inadequate response to previous or current treatment given at an approved dose for at least 3 months prior to baseline or have been intolerant to at least one administration of an anti-TNFα agent

You may not qualify if:

• Patients with total ankylosis of the spine
• Patients previously treated with any biological immunomodulating agents except for those targeting TNFα
• Active ongoing inflammatory diseases other than AS that might confound the evaluation of the benefit of secukinumab therapy, including inflammatory bowel disease or uveitis
• Known infection with HIV, hepatitis B or hepatitis C at screening or baseline

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (10)

Novartis Investigative Site

Kitakyushu, Fukuoka, 807-8556, Japan

Location

Novartis Investigative Site

Kita-gun, Kagawa-ken, 761-0793, Japan

Location

Novartis Investigative Site

Nankoku, Kochi, 783 8505, Japan

Location

Novartis Investigative Site

Tenri, Nara, 632-8552, Japan

Location

Novartis Investigative Site

Okayama, Okayama-ken, 700-0013, Japan

Location

Novartis Investigative Site

Kawachi-Nagano, Osaka, 586-8521, Japan

Location

Novartis Investigative Site

Suita, Osaka, 565 0871, Japan

Location

Novartis Investigative Site

Bunkyo Ku, Tokyo, 113-8431, Japan

Location

Novartis Investigative Site

Chuo Ku, Tokyo, 104-8560, Japan

Location

Novartis Investigative Site

Shinjuku-ku, Tokyo, 160-0054, Japan

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing; Spondylarthritis

Interventions

secukinumab; Equipment and Supplies

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Limitations and Caveats

This single arm study has no comparator and therefore no statistical test for comparison was planned for the outcome measures

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

1-888-669-6682

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 25, 2016
• Study Start: March 22, 2016
• Primary Completion: July 5, 2017
• Study Completion: May 16, 2018
• Last Updated: September 9, 2019
• Results First Posted: September 9, 2019

Record last verified: 2019-08

Locations

JP (10)