16 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis

NCT01358175 | Completed Phase 3 Results DMC

• 2 other identifiers: CAIN457F23052010-024529-18
• Study Type: interventional
• Target: 371
• Locations: 14 countries
• Sites: 67

Brief Summary

This study will assess the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing spondylitis; AS; ASAS; inflammatory back pain

Outcome Measures

Primary Outcomes (1)

• Assessment of Responders for the SpondyloArthritis International Society / ASAS 20 Response

  ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevent to AS and no worsening in the fourth domain. ASAS 20 is used to assess the efficacy of at least one dose of secukinumab against placebo.

  16 weeks

Secondary Outcomes (7)

• Assessment of Responders for the SpondyloArthritis International Society ASAS 40 Response

  16 weeks

• Change From Baseline in Serum hsCRP

  Base line and Week 16

• Assessment of Responders for the SpondyloArthritis International Society ASAS 5/6 Response

  16 weeks

• Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index / BASDAI

  Baseline and 16 weeks

• Change From Baseline in Physical Function Component of the Short-form Health Survey / SF-36 PCS

  baseline, 16 weeks

Study Arms (3)

Secukinumab 10 mg/kg i.v. / 75 mg s.c.

EXPERIMENTAL

Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.

Drug: Secukinumab (75 mg)

Secukinumab 10 mg/kg i.v. / 150 mg s.c.

EXPERIMENTAL

Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.

Drug: Secukinumab (150 mg)

Placebo

PLACEBO COMPARATOR

Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.

Drug: Placebo

Interventions

Secukinumab (75 mg) DRUG

Secukinumab (75 mg)

Secukinumab 10 mg/kg i.v. / 75 mg s.c.

Secukinumab (150 mg) DRUG

Secukinumab (150 mg)

Secukinumab 10 mg/kg i.v. / 150 mg s.c.

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• Male or non-pregnant, non-lactating female patients at least 18 years of age
• Diagnosis of moderate to severe AS with prior documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984)
• Patients should have been on NSAIDs with an inadequate response
• Patients who are regularly taking NSAIDs as part of their AS therapy are required to be on a stable dose
• Patients who have been on an anti-TNFα agent (not more than one) must have experienced an inadequate response

You may not qualify if:

• Chest X-ray with evidence of ongoing infectious or malignant process
• Patients with total ankylosis of the spine
• Patients previously treated with any biological immunomodulating agents except for those targeting TNFα
• Previous treatment with any cell-depleting therapies

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (67)

Novartis Investigative Site

Boise, Idaho, 83702, United States

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Novartis Investigative Site

Cedar Rapids, Iowa, 52401-2112, 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

Jackson, Tennessee, 38305, United States

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Novartis Investigative Site

Kingsport, Tennessee, 37660, United States

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Novartis Investigative Site

Austin, Texas, 78731, United States

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Novartis Investigative Site

Benbrook, Texas, 76126, United States

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Novartis Investigative Site

Dallas, Texas, 75231, United States

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Novartis Investigative Site

Spokane, Washington, 99204, United States

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Novartis Investigative Site

Brussels, 1200, Belgium

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Novartis Investigative Site

Genk, 3600, Belgium

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Novartis Investigative Site

Ghent, 9000, Belgium

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Novartis Investigative Site

Leuven, 3000, Belgium

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Novartis Investigative Site

Burgas, Bulgaria, 8000, Bulgaria

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Novartis Investigative Site

Plovdiv, Bulgaria, 4000, Bulgaria

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Novartis Investigative Site

Plovdiv, Bulgaria, 4002, Bulgaria

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Novartis Investigative Site

Sofia, Bulgaria, 1431, Bulgaria

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Novartis Investigative Site

Sofia, Bulgaria, 1612, Bulgaria

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Novartis Investigative Site

Winnipeg, Manitoba, R3A 1M3, Canada

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Novartis Investigative Site

St. John's, Newfoundland and Labrador, A1C 5B8, Canada

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Novartis Investigative Site

Toronto, Ontario, M5T 2S8, Canada

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Novartis Investigative Site

Bordeaux, 33076, France

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Novartis Investigative Site

Limoges, 87001, France

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Novartis Investigative Site

Paris, 75014, France

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Novartis Investigative Site

Berlin, Germany, 12203, Germany

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Novartis Investigative Site

Cologne, 50924, Germany

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Novartis Investigative Site

Erlangen, 91054, Germany

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Novartis Investigative Site

Hamburg, 22143, Germany

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Novartis Investigative Site

Hamburg, 22415, Germany

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Novartis Investigative Site

Herne, 44649, Germany

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Novartis Investigative Site

Jena, 07740, Germany

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Novartis Investigative Site

Magdeburg, 39110, Germany

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Novartis Investigative Site

Nuremberg, 90429, Germany

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Novartis Investigative Site

Ratingen, 40882, Germany

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Novartis Investigative Site

Valeggio sul Mincio, (vr), 37067, Italy

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Novartis Investigative Site

Brescia, BS, 25123, Italy

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Novartis Investigative Site

Catania, CT, 95100, Italy

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Novartis Investigative Site

Palermo, PA, 90127, Italy

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Novartis Investigative Site

Siena, SI, 53100, Italy

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Novartis Investigative Site

Torino, TO, 10126, Italy

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Novartis Investigative Site

Mexicali, Estado de Baja California, 21100, Mexico

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Novartis Investigative Site

Guadalajara, Jalisco, 44160, Mexico

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Novartis Investigative Site

Monterrey, Nuevo León, 64020, Mexico

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Novartis Investigative Site

Culiacán, Sinaloa, 80000, Mexico

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Novartis Investigative Site

Amsterdam, 1105 AZ, Netherlands

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Novartis Investigative Site

Utrecht, 3584 CX, Netherlands

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Novartis Investigative Site

Jesus Maria, Lima region, 11, Peru

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Novartis Investigative Site

La Victoria, Lima region, 13, Peru

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Novartis Investigative Site

Pueblo Libre, Lima region, 21, Peru

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Novartis Investigative Site

San Isidro, Lima region, 27, Peru

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Novartis Investigative Site

Surquillo, Lima region, 34, Peru

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Novartis Investigative Site

Moscow, 115522, Russia

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Novartis Investigative Site

Saint Petersburg, 197341, Russia

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Novartis Investigative Site

Tula, 300053, Russia

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Novartis Investigative Site

Yaroslavl, 150003, Russia

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Novartis Investigative Site

Yekaterinburg, 620028, Russia

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Novartis Investigative Site

Yekaterinburg, 620102, Russia

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Novartis Investigative Site

Taichung, Taiwan ROC, 40201, Taiwan

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Novartis Investigative Site

Kaohsiung City, 81346, Taiwan

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Novartis Investigative Site

Balcova / Izmir, 35340, Turkey (Türkiye)

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Novartis Investigative Site

Fatih / Istanbul, 34098, Turkey (Türkiye)

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Novartis Investigative Site

Gaziantep, 27310, Turkey (Türkiye)

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Novartis Investigative Site

London, England, E11 1NR, United Kingdom

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Novartis Investigative Site

Cambridge, CB2 2QQ, United Kingdom

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Novartis Investigative Site

Newcastle upon Tyne, NE1 4LP, United Kingdom

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Novartis Investigative Site

Wolverhampton, WV10 0QP, United Kingdom

Location

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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: Clinical Disclosure Office
• Organization: Novartis Pharmaceuticals

862-778-8300

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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2011
• First Posted: May 23, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 9, 2017
• Results First Posted: January 27, 2017

Record last verified: 2017-01

Locations

BU (5); CA (3); RU (6); FR (3); US (10); DE (10); ME (4); NL (2); BE (4); PE (5); TW (2); GB (4); TU (3); IT (6)