Study Estimating the Clinical Difference Between 300 mg and 150 mg of Secukinumab Following Dose Escalation to 300 mg in Patients With Ankylosing Spondylitis

NCT03350815 | Completed Phase 4 Results FDA Drug

• 1 other identifier: CAIN457FUS06
• Study Type: interventional
• Target: 322
• Locations: 1 country
• Sites: 65

Brief Summary

This was a study estimating the clinical difference between 300 mg and 150 mg of secukinumab following dose escalation to 300 mg in patients with ankylosing spondylitis

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing spondylitis; ASDAS inactive disease; secukinumab; ASDAS

Outcome Measures

Primary Outcomes (1)

• The Proportion of Participants Who Achieved Inactive Disease Based on the Ankylosing Spondylitis Disease Activity Score (ASDAS) Measure

  Proportion of participants with inadequate response at week 16 who achieved inactive disease at Week 52 The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index to assess disease activity in AS. The ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) were utilized to assess the disease activity status. * \< 1.3 between inactive disease and moderate disease activity, * \< 2.1 between moderate disease activity and high disease activity, and * 3.5 between high disease activity and very high disease activity.

  Week 52

Secondary Outcomes (8)

• The Proportion of Participants Who Achieved a Clinically Important Improvement on the Ankylosing Spondylitis Disease Activity Score (ASDAS) Scale

  Baseline, Week 52

• Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  Baseline, Week 52

• Proportion of Patients Who Achieved Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI-50)

  Baseline, Week 52

• The Proportion of Participants Who Achieved an ASAS 20 Response (Assessment of SpondyloArthritis International Society Criteria)

  Week 52

• The Proportion of Participants Who Achieved an ASAS 40 Response

  Week 52

Study Arms (3)

Responders

ACTIVE COMPARATOR

Patients who achieved an Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease (total score \<1.3) at both Week 12 and Week 16.

Drug: 150 mg open-label secukinumab; Drug: 150 mg double-blinded secukinumab

Inadequate responders

ACTIVE COMPARATOR

Patients who have active disease, defined as an Ankylosing Spondylitis Disease Activity Score (ASDAS) total score of \>1.3 at both Week 12 and Week 16, and who achieved a decrease (improvement) from baseline in total ASDAS score at both Week 12 and Week 16.

Drug: 150 mg open-label secukinumab; Drug: 150 mg double-blinded secukinumab; Drug: 300 mg double-blinded secukinumab

Non-responders

ACTIVE COMPARATOR

Patients who exhibit no change or an increase (worsening) from baseline in total Ankylosing Spondylitis Disease Activity Score (ASDAS) score at either Week 12 or Week 16. Non-responders were not entered Treatment Period 2. Non-responders were discontinued from the study at Week 16.

Drug: 150 mg open-label secukinumab

Interventions

150 mg open-label secukinumab DRUG

All patients in Treatment Period 1 received 150 mg s.c. injection open-label secukinumab.

Also known as: AIN457

Inadequate responders; Non-responders; Responders

150 mg double-blinded secukinumab DRUG

Treatment Period 2 Patients who achieved responder status entered Treatment Period 2 and continued to receive 150 mg s.c. (1 s.c. injection of secukinumab 150 mg)

Also known as: AIN457

Inadequate responders; Responders

300 mg double-blinded secukinumab DRUG

Treatment Period 2 300 mg (2 s.c. injections of the 150 mg dose)

Also known as: AIN457

Inadequate responders

Eligibility Criteria

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

You may qualify if:

• Understand and communicate with the investigator, comply with the requirements of the study and give a written, signed and dated informed consent
• Male or non-pregnant, non-lactating female patients at least 18 years of age
• Diagnosis of moderate to severe Ankylosing Spondylitis (AS) with prior documented radiologic evidence fulfilling the Modified New York criteria for AS
• Active AS assessed by total Bath Ankylosing Spondylitis Disease Activity index (BASDAI) ≥ 4 (0-10) at baseline
• Spinal pain as measured by BASDAI question #2 ≥ 4 cm (0-10 cm) at baseline
• Total back pain as measured by visual analog scale (VAS) ≥ 40 mm (0-100 mm) at baseline
• Patients should have been on non-steroidal anti-inflammatory drugs (NSAIDs) at the maximum tolerated dose for at least 4 weeks prior to their Baseline Visit, with an inadequate response or for less than 4 weeks if withdrawn for intolerance, toxicity or contraindications
• Stable dose of NSAIDs including Cyclooxygenase-1 (COX-1) or Cyclooxygenase-2 (COX-2) inhibitors for at least 2 weeks before their Baseline Visit
• Patients who have been on a tumor necrosis factor alpha (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 had been intolerant upon administration of an anti-TNFα agent

You may not qualify if:

• Total ankylosis of the spine
• Use of other investigational drugs within 5 half-lives of enrollment, or within 4 weeks before the Baseline Visit, whichever is longer.
• History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
• Chest x-ray, computerized tomography (CT) scan, or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician.
• Previous exposure to secukinumab or any other biologic drug directly targeting Interleukin-17 (IL-17), Interleukin-12/23 (IL-12/23), or the IL-17 receptor, or any other biologic immunomodulating agent, except those targeting TNFα
• Patients who have taken more than one anti-TNFα agent
• Any intramuscular or intravenous corticosteroid injection within 2 weeks before baseline
• Any therapy by intra-articular injections (e.g. corticosteroid) within 4 weeks before baseline
• Previous treatment with any cell-depleting therapies
• Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, morphine)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (65)

Novartis Investigative Site

Jonesboro, Arkansas, 72401, United States

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Novartis Investigative Site

Fullerton, California, 92835, United States

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Novartis Investigative Site

Loma Linda, California, 92354, United States

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Novartis Investigative Site

Palm Desert, California, 92260, United States

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Novartis Investigative Site

Tustin, California, 92780, United States

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Novartis Investigative Site

Upland, California, 91786, United States

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Novartis Investigative Site

Aventura, Florida, 33180, United States

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Novartis Investigative Site

Boca Raton, Florida, 33486, United States

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Novartis Investigative Site

Brandon, Florida, 33511, United States

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Novartis Investigative Site

DeLand, Florida, 32720, United States

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Novartis Investigative Site

Gainesville, Florida, 32608, United States

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Novartis Investigative Site

Orlando, Florida, 32810, United States

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Novartis Investigative Site

Plantation, Florida, 33324, United States

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Novartis Investigative Site

St. Petersburg, Florida, 33705, United States

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Novartis Investigative Site

Tamarac, Florida, 33321, United States

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Novartis Investigative Site

Tampa, Florida, 33609, United States

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Novartis Investigative Site

Zephyrhills, Florida, 33542, United States

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Novartis Investigative Site

Duluth, Georgia, 30096, United States

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Novartis Investigative Site

Springfield, Illinois, 62703, United States

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Novartis Investigative Site

Vernon Hills, Illinois, 60061, United States

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Novartis Investigative Site

Evansville, Indiana, 47715, United States

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Novartis Investigative Site

Monroe, Louisiana, 71203, United States

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Novartis Investigative Site

Cumberland, Maryland, 21740, United States

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Novartis Investigative Site

Hagerstown, Maryland, 21740, United States

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Novartis Investigative Site

Wheaton, Maryland, 20902, United States

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Novartis Investigative Site

Boston, Massachusetts, 02111, United States

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Novartis Investigative Site

Worcester, Massachusetts, 01655, United States

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Novartis Investigative Site

Ann Arbor, Michigan, 48109 5271, United States

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Novartis Investigative Site

Saint Clair Shores, Michigan, 48081, United States

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Novartis Investigative Site

Edina, Minnesota, 55435, United States

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Novartis Investigative Site

Springfield, Missouri, 65810, United States

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Novartis Investigative Site

Midland Park, New Jersey, 07432, United States

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Novartis Investigative Site

Voorhees Township, New Jersey, 08043, United States

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Novartis Investigative Site

Albuquerque, New Mexico, 87102, United States

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Novartis Investigative Site

Santa Fe, New Mexico, 87505, United States

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Novartis Investigative Site

Brooklyn, New York, 11201, United States

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Novartis Investigative Site

New York, New York, 10016, United States

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Novartis Investigative Site

Orchard Park, New York, 14127, United States

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Novartis Investigative Site

Potsdam, New York, 13676, United States

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Novartis Investigative Site

Minot, North Dakota, 58701, United States

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Novartis Investigative Site

Cincinnati, Ohio, 45219, United States

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Novartis Investigative Site

Dayton, Ohio, 45402, United States

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Novartis Investigative Site

Middleburg Heights, Ohio, 44130, United States

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Novartis Investigative Site

Oklahoma City, Oklahoma, 73103, United States

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Novartis Investigative Site

Corvallis, Oregon, 97330, United States

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Novartis Investigative Site

Portland, Oregon, 97239, United States

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Novartis Investigative Site

Duncansville, Pennsylvania, 16635, United States

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Novartis Investigative Site

Wexford, Pennsylvania, 15090, United States

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Novartis Investigative Site

Charleston, South Carolina, 29460, United States

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Novartis Investigative Site

Columbia, South Carolina, 29204, United States

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Novartis Investigative Site

Jackson, Tennessee, 38305, United States

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Novartis Investigative Site

Memphis, Tennessee, 38119, United States

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Novartis Investigative Site

Beaumont, Texas, 77701, United States

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Novartis Investigative Site

Colleyville, Texas, 76034, United States

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Novartis Investigative Site

Dallas, Texas, 75231, United States

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Novartis Investigative Site

Houston, Texas, 77025, United States

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Novartis Investigative Site

Houston, Texas, 77089, United States

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Novartis Investigative Site

Mesquite, Texas, 75150, United States

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Novartis Investigative Site

Salt Lake City, Utah, 84132, United States

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Novartis Investigative Site

Seattle, Washington, 98104, United States

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Novartis Investigative Site

Seattle, Washington, 98195, United States

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Novartis Investigative Site

Spokane, Washington, 99204, United States

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Novartis Investigative Site

Charleston, West Virginia, 25304, United States

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Novartis Investigative Site

Manitowoc, Wisconsin, 54220, United States

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Novartis Investigative Site

Onalaska, Wisconsin, 54650, United States

Location

Related Publications (1)

• Deodhar A, Kivitz AJ, Magrey M, Walsh JA, Mease PJ, Greenwald M, Kianifard F, Elam C, Bommidi GM, Winseck A, Gensler LS. A secukinumab dose-escalation study in patients with ankylosing spondylitis not achieving inactive disease after 16 weeks of treatment. Rheumatology (Oxford). 2025 Apr 1;64(4):1864-1872. doi: 10.1093/rheumatology/keae432.

  PMID: 39133200 DERIVED

Related Links

• A Plain Language Trial Summary is available on novctrd.com

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

secukinumab

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

+1 (862) 778-8300

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients and Investigators will be blinded to the secukinumab dose during Treatment Period 2.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This was a randomized, double-blind, parallel-group, multicenter design which included an initial 16 week open-label period (Treatment Period 1) followed by a randomized, double-blind, parallel-group period (Treatment Period 2),

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 22, 2017
• Study Start: March 13, 2018
• Primary Completion: March 11, 2021
• Study Completion: May 29, 2021
• Last Updated: April 29, 2022
• Results First Posted: April 8, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

US (65)