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

A Randomized, Double-blind, Parallel-group, Multicenter Study of Secukinumab to Compare 300 mg and 150 mg at Week 52 in Patients With Ankylosing Spondylitis Who Are Randomized to Dose Escalation After Not Achieving Inactive Disease During an Initial 16 Weeks of Open-label Treatment With Secukinumab 150 mg (ASLeap)

ClinicalTrials.gov Identifier: NCT03350815

Novartis Reference Number: CAIN457FUS06

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Ankylosing Spondylitis
Phase 
Phase 4
Overall status 
Active, not recruiting
Enrollment count 
313 participants
Start date 
Mar 13, 2018
Completion date 
May 28, 2021
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
150 mg open-label secukinumab
All patients in Treatment Period 1 will receive 150 mg open-label secukinumab.
Drug
150 mg double-blinded secukinumab
Treatment Period 2
Drug
300 mg double-blinded secukinumab
Treatment Period 2

Eligibility Criteria

Key Inclusion Criteria:

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dose for at least 4 weeks prior to their Baseline Visit, with an inadequate response or for less than 4 weeks if withdrawn for intolerance, toxicity or contraindications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

Key Exclusion Criteria:

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)

Other protocol-defined inclusion/exclusion criteria may apply.

Study Locations

United States
Novartis Investigative Site
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Jonesboro, 72401
Arkansas
United States
Novartis Investigative Site
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Fullerton, 92835
California
United States
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Huntington Beach, 92646
California
United States
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Loma Linda, 92354
California
United States
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Palm Desert, 92260
California
United States
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Tustin, 92780
California
United States
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Upland, 91786
California
United States
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Danbury, 06810
Connecticut
United States
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Aventura, 33180
Florida
United States
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Boca Raton, 33486
Florida
United States
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Brandon, 33511
Florida
United States
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DeLand, 32720
Florida
United States
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Gainesville, 32608
Florida
United States
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Orlando, 32806
Florida
United States
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Orlando, 32810
Florida
United States
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Plantation, 33324
Florida
United States
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Saint Petersburg, 33705
Florida
United States
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Tamarac, 33321
Florida
United States
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Tampa, 33609
Florida
United States
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Zephyrhills, 33542
Florida
United States
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Duluth, 30096
Georgia
United States
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Springfield, 62703
Illinois
United States
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Vernon Hills, 60061
Illinois
United States
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Evansville, 47715
Indiana
United States
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Monroe, 71203
Louisiana
United States
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Cumberland, 21740
Maryland
United States
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Hagerstown, 21740
Maryland
United States
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Wheaton, 20902
Maryland
United States
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Boston, 02111
Massachusetts
United States
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Worcester, 01655
Massachusetts
United States
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Ann Arbor, 48109 5271
Michigan
United States
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Saint Clair Shores, 48081
Michigan
United States
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Edina, 55435
Minnesota
United States
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Springfield, 65810
Missouri
United States
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Midland Park, 07432
New Jersey
United States
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Voorhees, 08043
New Jersey
United States
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Albuquerque, 87102
New Mexico
United States
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Santa Fe, 87505
New Mexico
United States
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Brooklyn, 11201
New York
United States
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New York, 10016
New York
United States
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Orchard Park, 14127
New York
United States
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Potsdam, 13676
New York
United States
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Minot, 58701
North Dakota
United States
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Cincinnati, 45219
Ohio
United States
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Dayton, 45402
Ohio
United States
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Middleburg Heights, 44130
Ohio
United States
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Oklahoma City, 73103
Oklahoma
United States
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Corvallis, 97330
Oregon
United States
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Portland, 97239
Oregon
United States
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Duncansville, 16635
Pennsylvania
United States
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Philadelphia, 19104
Pennsylvania
United States
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Wexford, 15090
Pennsylvania
United States
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Charleston, 29460
South Carolina
United States
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Columbia, 29204
South Carolina
United States
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Jackson, 38305
Tennessee
United States
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Memphis, 38119
Tennessee
United States
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Beaumont, 77701
Texas
United States
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Colleyville, 76034
Texas
United States
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Dallas, 75231
Texas
United States
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Edinburg, 78539
Texas
United States
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Houston, 77025
Texas
United States
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Houston, 77089
Texas
United States
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Mesquite, 75150
Texas
United States
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San Antonio, 78284
Texas
United States
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Salt Lake City, 84132
Utah
United States
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Seattle, 98104
Washington
United States
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Seattle, 98195
Washington
United States
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Spokane, 99204
Washington
United States
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Charleston, 25304
West Virginia
United States
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Manitowoc, 54220
Wisconsin
United States
Novartis Investigative Site
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Onalaska, 54650
Wisconsin
United States

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