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



Status:Recruiting
Conditions:Arthritis, Neurology, Neurology
Therapuetic Areas:Neurology, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:2/24/2019
Start Date:March 13, 2018
End Date:August 31, 2020
Contact:Novartis Pharmaceuticals
Email:novartis.email@novartis.com
Phone:1-888-669-6682

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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)

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


Key Inclusion Criteria:

1. Understand and communicate with the investigator, comply with the requirements of the
study and give a written, signed and dated informed consent

2. Male or non-pregnant, non-lactating female patients at least 18 years of age

3. Diagnosis of moderate to severe Ankylosing Spondylitis (AS) with prior documented
radiologic evidence fulfilling the Modified New York criteria for AS

4. Active AS assessed by total Bath Ankylosing Spondylitis Disease Activity index
(BASDAI) ≥ 4 (0-10) at baseline

5. Spinal pain as measured by BASDAI question #2 ≥ 4 cm (0-10 cm) at baseline

6. Total back pain as measured by visual analog scale (VAS) ≥ 40 mm (0-100 mm) at
baseline

7. 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inadequate response or for less than 4 weeks if withdrawn for intolerance, toxicity or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

8. Stable dose of NSAIDs including Cyclooxygenase-1 (COX-1) or Cyclooxygenase-2 (COX-2)
inhibitors for at least 2 weeks before their Baseline Visit

9. 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:

1. Total ankylosis of the spine

2. Use of other investigational drugs within 5 half-lives of enrollment, or within 4
weeks before the Baseline Visit, whichever is longer.

3. History of hypersensitivity to any of the study drugs or its excipients or to drugs of
similar chemical classes.

4. 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.

5. 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

6. Patients who have taken more than one anti-TNFα agent

7. Any intramuscular or intravenous corticosteroid injection within 2 weeks before
baseline

8. Any therapy by intra-articular injections (e.g. corticosteroid) within 4 weeks before
baseline

9. Previous treatment with any cell-depleting therapies

10. Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone,
morphine)

Other protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
57
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Voorhees, New Jersey 08043
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Albuquerque, New Mexico 87108
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Aventura, Florida 33180
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Beaumont, Texas 77702
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Boca Raton, Florida 33486
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Boston, Massachusetts 02118
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Brandon, Florida 33511
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Brooklyn, New York 11218
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Charleston, West Virginia 25304
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Cincinnati, Ohio 45229
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Colleyville, Texas 76034
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Columbia, South Carolina 29201
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Corvallis, Oregon 97330
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Dallas, Texas 75216
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Danbury, Connecticut 06810
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Dayton, Ohio 45402
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Deland, Florida 32720
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Duluth, Georgia 30096
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Duncansville, Pennsylvania 16635
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Edina, Minnesota 55435
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Evansville, Indiana 47713
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Fullerton, California 92835
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Gainesville, Florida 32608
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Hagerstown, Maryland 21742
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Houston, Texas 77030
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Huntington Beach, California 92647
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Jackson, Tennessee 38305
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Jonesboro, Arkansas 72401
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Manitowoc, Wisconsin 54221
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Memphis, Tennessee 38120
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Mesquite, Texas 75150
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Middleburg Heights, Ohio 44130
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Midland Park, New Jersey 07432
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Minot, North Dakota 58701
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Monroe, Louisiana 71203
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Oklahoma City, Oklahoma 73104
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Onalaska, Wisconsin 54650
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Orchard Park, New York 14127
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Orlando, Florida 32806
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Palm Desert, California 92211
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Plantation, Florida 33324
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Portland, Oregon 97228
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Potsdam, New York 13676
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Saint Clair Shores, Michigan 48081
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Saint Petersburg, Florida 33701
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Santa Fe, New Mexico 87505
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Seattle, Washington 98103
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Spokane, Washington 99202
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Springfield, Illinois 62703
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Springfield, Missouri 65804
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Tamarac, Florida 33321
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Tampa, Florida 33613
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Tustin, California 92780
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Upland, California 91786
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Vernon Hills, Illinois 60061
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Wexford, Pennsylvania 15090
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Wheaton, Maryland 20902
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