Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2011-002325-22-GB
• Date of registration: 18/06/2013
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly & Company
• Public title: Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)
• Scientific title: A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients with Active Ankylosing Spondylitis - SPIRIT-A1
• Date of first enrolment: 26/09/2013
• Target sample size: 408
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002325-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Belgium, Canada, Czech Republic, Estonia, France, Germany, Hungary, Mexico, Netherlands, Poland, Russian Federation, South Africa, Spain, Ukraine, United Kingdom, United States

Contacts

• Name: Clinical Trial Information
• Affiliation: Eli Lilly

• Name: Clinical Trial Information
• Affiliation: Eli Lilly

Key inclusion & exclusion criteria

Inclusion criteria:
? Diagnosis of moderate to severe AS with prior documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984)
? Have active AS defined as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) =4 and the spinal pain (back pain) score =4 on a numeric rating scale (NRS)
? Participants should have been on nonsteroidal anti-inflammatory drugs (NSAIDs) with an inadequate response
? Participants who are regularly taking NSAIDs or cyclooxygenase-2 (COX-2) inhibitors as part of their AS therapy are required to be on a stable dose
? Participants who have been on a tumor necrosis factor alpha (TNF) inhibitor (not more than one) must have experienced an inadequate response
? Total duration of prior therapy (NSAIDs and/or adequate physical therapy) should be at least 12 weeks
? Men must agree to use a reliable method of birth control or remain abstinent during the study
? Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 388
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion criteria:
? Participants with a total ankylosis of the spine
? Prior or current treatment with adalimumab
? Patients previously treated with any biological or other immunomodulating agents except for those targeting TNF
? Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than ankylosing spondylitis
? Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
? Serious disorder or illness other than ankylosing spondylitis
? Serious infection within the last 3 months
? Breastfeeding or nursing (lactating) women


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Spondylitis, Ankylosing
MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Intervention(s)

Product Name: Ixekizumab
Product Code: LY2439821
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Ixekizumab
CAS Number: 1143503-69-8
Current Sponsor code: LY2439821
Other descriptive name: Monoclonal Antibody (MAb)
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 80-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Trade Name: Adalimumab
Product Name: Adalimumab
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active ankylosing spondylitis based on ASAS20 at 16 Weeks

Timepoint(s) of evaluation of this end point: At 16 Weeks

Primary end point(s): Efficacy of ixekizumab in participants with Ankylosing
Spondylitis (AS). Measure: Assessment of Spondyloarthritis International Society (ASAS) 20 Response

Secondary Objective: Efficacy of either ixekizumab compared to placebo in patients with active AS based on the following measures at Week 16:

-Proportion of biologic naïve patients who achieve an ASAS40 response.
-peripheral tender or swollen joint counts
-Change from baseline in patient-reported quality of life and other outcomes assessments
-Change from baseline in non-arthritic aisease assessments
-spinal mobility


Efficacy of either ixekizumab compared to placebo in patients with active AS based on the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) change from baseline at Week 108.

Secondary Outcome(s)

Secondary end point(s): 1) Efficacy of ixekizumab in participants with AS. Measure:
ASAS
2) Quality of life and outcome assessments. Measures: Patient
Reported Outcomes (PRO)
3) Efficacy of ixekizumab in participants with AS. Measure:
Non-Arthritic Disease Assessments
4) Efficacy of ixekizumab in participants with AS. Measure:
Peripheral Joint Counts
5) Efficacy of ixekizumab in participants with AS. Measure:
Spinal Mobility
6) Efficacy of ixekizumab in participants with Ankylosing
Spondylitis (AS). Measure: modified Stoke Ankylosing
Spondylitis Spinal Score (mSASSS)

Timepoint(s) of evaluation of this end point: 1) 16 Weeks
2) Baseline through 16 Weeks
3) Baseline through 16 Weeks
4) 16 Weeks
5) Baseline through 16 Weeks
6) Baseline through 108 Weeks

Secondary ID(s)

I1F-MC-RHAO

Source(s) of Monetary Support

Eli Lilly & Company

Ethics review

Status: Approved
Approval date:
Contact: