SELECT-AXIS 1

A Study Evaluating the Safety and Efficacy of an Active Drug in Subjects With Active Ankylosing Spondylitis ( SELECT Axis 1 )

Brief summary

This is a Phase 2 multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of an active drug in participants with active ankylosing spondylitis (AS).

Interventional study

Status:
Completed
Conditions:
Ankylosing Spondylitis (AS)
Enrollment:
187 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M16-098
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

18 Years and older.

Inclusion Criteria:

- Participant with a clinical diagnosis of ankylosing spondylitis (AS) and meeting the
modified New York criteria for AS.

- Participant must have baseline disease activity as defined by having a Bath Ankylosing
Spondylitis Disease Activity Index (BASDAI) score >= 4 and a Patient's Assessment of
Total Back Pain score >= 4 based on a 0 - 10 numeric rating scale (NRS) at the
Screening and Baseline visits.

- Participant has had an inadequate response to at least two nonsteroidal
anti-inflammatory drugs (NSAIDs) over an at least 4-week period in total at maximum
recommended or tolerated doses, or participant has an intolerance to or
contraindication for NSAIDs as defined by the Investigator.

- If entering the study on concomitant methotrexate (MTX), leflunomide, sulfasalazine
(SSZ), and/or hydroxychloroquine, participant must be on a stable dose of MTX (<= 25
mg/week) and/or SSZ (<= 3 g/day) and/or hydroxychloroquine (<= 400 mg/day) or
leflunomide (<= 20 mg/day) for at least 28 days prior to the Baseline visit. A
combination of up to two background conventional synthetic disease-modifying
anti-rheumatic drugs (csDMARDs) is allowed except the combination of MTX and
leflunomide.

- If entering the study on concomitant oral corticosteroids, participant must be on a
stable dose of prednisone (<= 10 mg/day), or oral corticosteroid equivalents, for at
least 14 days prior to the Baseline visit.

- If entering the study on concomitant NSAIDs, tramadol, combination of acetaminophen
and codeine or hydrocodone, and/or non-opioid analgesics, participant must be on
stable dose(s) for at least 14 days prior to the Baseline visit.

Exclusion Criteria:

- Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to
tofacitinib, baricitinib, and filgotinib).

- Prior exposure to any biologic therapy with a potential therapeutic impact on
spondyloarthritis (SpA).

- Intra-articular joint injections, spinal/paraspinal injection(s), or parenteral
administration of corticosteroids within 28 days prior to the Baseline visit. Inhaled
or topical corticosteroids are allowed.

- Participant on any other DMARDs (other than those allowed), thalidomide or apremilast
within 28 days or five half-lives (whichever is longer) of the drug prior to the
Baseline visit.

- Participant on opioid analgesics (except for combination acetaminophen/codeine or
acetaminophen/hydrocodone which are allowed) or use of inhaled marijuana within 14
days prior to the Baseline visit.

- Participant has a history of inflammatory arthritis of different etiology other than
axial SpA (including but not limited to rheumatoid arthritis, psoriatic arthritis,
mixed connective tissue disease, systemic lupus erythematosus, reactive arthritis,
scleroderma, polymyositis, dermatomyositis, fibromyalgia), or any arthritis with onset
prior to 17 years of age.

- Laboratory values meeting the following criteria within the Screening period prior to
the first dose of study drug: serum aspartate transaminase > 2 × upper limit of normal
(ULN); serum alanine transaminase > 2 × ULN; estimated glomerular filtration rate by
simplified 4-variable Modification of Diet in Renal Disease formula < 40 milliliter
(mL)/minute/1.73m^2; hemoglobin < 10 gram/deciliter, total white blood cell count <
2,500/microliter (μL); absolute neutrophil count < 1,500/μL; absolute lymphocyte count
< 800/μL; and platelet count < 100,000/μL.

All the cities where the clinical studies are located

Edmonton - T5M 0H4
Edmonton - T6G 2B7
Mississauga - L5M 2V8
Sainte-foy - G1V 3M7

Alberta

Ontario

Quebec