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

Use our guide to learn which trials are right for you!

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inadequate response or for less than 4 weeks if withdrawn for intolerance, toxicity or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
sites
Beaumont, Texas 77702
926
mi
from 43215
Beaumont, TX
Click here to add this to my saved trials
Albuquerque, New Mexico 87108
1330
mi
from 43215
Albuquerque, NM
Click here to add this to my saved trials
Aventura, Florida 33180
982
mi
from 43215
Aventura, FL
Click here to add this to my saved trials
Boca Raton, Florida 33486
955
mi
from 43215
Boca Raton, FL
Click here to add this to my saved trials
Boston, Massachusetts 02118
643
mi
from 43215
Boston, MA
Click here to add this to my saved trials
Brandon, Florida 33511
834
mi
from 43215
Brandon, FL
Click here to add this to my saved trials
Brooklyn, New York 11218
478
mi
from 43215
Brooklyn, NY
Click here to add this to my saved trials
Charleston, West Virginia 25304
133
mi
from 43215
Charleston, WV
Click here to add this to my saved trials
Cincinnati, Ohio 45229
95
mi
from 43215
Cincinnati, OH
Click here to add this to my saved trials
Colleyville, Texas 76034
923
mi
from 43215
Colleyville, TX
Click here to add this to my saved trials
Columbia, South Carolina 29201
427
mi
from 43215
Columbia, SC
Click here to add this to my saved trials
Corvallis, Oregon 97330
2060
mi
from 43215
Corvallis, OR
Click here to add this to my saved trials
Dallas, Texas 75216
914
mi
from 43215
Dallas, TX
Click here to add this to my saved trials
Danbury, Connecticut 06810
510
mi
from 43215
Danbury, CT
Click here to add this to my saved trials
Dayton, Ohio 45402
64
mi
from 43215
Dayton, OH
Click here to add this to my saved trials
Deland, Florida 32720
761
mi
from 43215
Deland, FL
Click here to add this to my saved trials
Duluth, Georgia 30096
416
mi
from 43215
Duluth, GA
Click here to add this to my saved trials
Duncansville, Pennsylvania 16635
244
mi
from 43215
Duncansville, PA
Click here to add this to my saved trials
Edina, Minnesota 55435
624
mi
from 43215
Edina, MN
Click here to add this to my saved trials
Evansville, Indiana 47713
280
mi
from 43215
Evansville, IN
Click here to add this to my saved trials
Fullerton, California 92835
1959
mi
from 43215
Fullerton, CA
Click here to add this to my saved trials
Gainesville, Florida 32608
716
mi
from 43215
Gainesville, FL
Click here to add this to my saved trials
Hagerstown, Maryland 21742
282
mi
from 43215
Hagerstown, MD
Click here to add this to my saved trials
Houston, Texas 77030
995
mi
from 43215
Houston, TX
Click here to add this to my saved trials
Huntington Beach, California 92647
1968
mi
from 43215
Huntington Beach, CA
Click here to add this to my saved trials
Jackson, Tennessee 38305
436
mi
from 43215
Jackson, TN
Click here to add this to my saved trials
Jonesboro, Arkansas 72401
506
mi
from 43215
Jonesboro, AR
Click here to add this to my saved trials
Manitowoc, Wisconsin 54221
370
mi
from 43215
Manitowoc, WI
Click here to add this to my saved trials
Memphis, Tennessee 38120
501
mi
from 43215
Memphis, TN
Click here to add this to my saved trials
Mesquite, Texas 75150
901
mi
from 43215
Mesquite, TX
Click here to add this to my saved trials
Middleburg Heights, Ohio 44130
115
mi
from 43215
Middleburg Heights, OH
Click here to add this to my saved trials
Midland Park, New Jersey 07432
?
mi
from 43215
Midland Park, NJ
Click here to add this to my saved trials
Minot, North Dakota 58701
1067
mi
from 43215
Minot, ND
Click here to add this to my saved trials
Monroe, Louisiana 71203
721
mi
from 43215
Monroe, LA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
848
mi
from 43215
Oklahoma City, OK
Click here to add this to my saved trials
Onalaska, Wisconsin 54650
?
mi
from 43215
Onalaska, WI
Click here to add this to my saved trials
Orchard Park, New York 14127
294
mi
from 43215
Orchard Park, NY
Click here to add this to my saved trials
Orlando, Florida 32806
797
mi
from 43215
Orlando, FL
Click here to add this to my saved trials
Palm Desert, California 92211
1882
mi
from 43215
Palm Desert, CA
Click here to add this to my saved trials
Plantation, Florida 33324
970
mi
from 43215
Plantation, FL
Click here to add this to my saved trials
Portland, Oregon 97228
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
2028
mi
from 43215
Portland, OR
Click here to add this to my saved trials
Potsdam, New York 13676
523
mi
from 43215
Potsdam, NY
Click here to add this to my saved trials
Saint Clair Shores, Michigan 48081
175
mi
from 43215
Saint Clair Shores, MI
Click here to add this to my saved trials
Saint Petersburg, Florida 33701
842
mi
from 43215
Saint Petersburg, FL
Click here to add this to my saved trials
Santa Fe, New Mexico 87505
1281
mi
from 43215
Santa Fe, NM
Click here to add this to my saved trials
Seattle, Washington 98103
2007
mi
from 43215
Seattle, WA
Click here to add this to my saved trials
Spokane, Washington 99202
1778
mi
from 43215
Spokane, WA
Click here to add this to my saved trials
Springfield, Illinois 62703
350
mi
from 43215
Springfield, IL
Click here to add this to my saved trials
Springfield, Missouri 65804
585
mi
from 43215
Springfield, MO
Click here to add this to my saved trials
Tamarac, Florida 33321
963
mi
from 43215
Tamarac, FL
Click here to add this to my saved trials
Tampa, Florida 33613
821
mi
from 43215
Tampa, FL
Click here to add this to my saved trials
Tustin, California 92780
1957
mi
from 43215
Tustin, CA
Click here to add this to my saved trials
Upland, California 91786
1940
mi
from 43215
Upland, CA
Click here to add this to my saved trials
Vernon Hills, Illinois 60061
300
mi
from 43215
Vernon Hills, IL
Click here to add this to my saved trials
Voorhees, New Jersey 08043
427
mi
from 43215
Voorhees, NJ
Click here to add this to my saved trials
Wexford, Pennsylvania 15090
162
mi
from 43215
Wexford, PA
Click here to add this to my saved trials
Wheaton, Maryland 20902
325
mi
from 43215
Wheaton, MD
Click here to add this to my saved trials