SELECT AXIS 2

A Study to Evaluate Efficacy and Safety of an Active Drug in Adult Participants With Axial Spondyloarthritis

Brief summary

This protocol includes 2 standalone studies with randomization, data collection, analysis and reporting conducted independently.

The main objectives of this protocol are:

- To evaluate the efficacy of an active drug compared with placebo on reduction of signs and symptoms in adult participants with active axial spondyloarthritis (axSpA) including biologic disease-modifying antirheumatic drug inadequate responders (bDMARD-IR) ankylosing spondylitis (AS) (Study 1) and non-radiographic axial spondyloarthritis (nr-axSpA) (Study 2).

- To assess the safety and tolerability of an active drug in adult participants with active axSpA including bDMARD-IR AS (Study 1) and with nr-axSpA (Study 2).

Interventional study

Status:
Recruiting
Conditions:
Spondyloarthritis
Enrollment:
690 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M19-944
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:

- Study 1: Participant has the clinical diagnosis of ankylosing spondylitis (AS) who
meet the modified New York Criteria for AS (Study 1); OR

- Study 2: Participant has the clinical diagnosis of nr-axSpA fulfilling the 2009 ASAS
classification criteria for axSpA but not meeting the radiologic criterion of the
modified New York criteria for AS and have objective signs of active inflammation on
magnetic resonance imaging (MRI) or based on high sensitivity C-reactive protein
(CRP).

- Study 1 and Study 2: Participant must have 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 numerical rating scale at the Screening and Baseline Visits.

- Study 1: Participants must have had an inadequate response to biologic
disease-modifying antirheumatic drug (bDMARD) therapy.

- Study 2: Participant with prior treatment with bDMARD-therapy is allowed.

Exclusion Criteria:

- Participant must not have been exposed to Janus Kinase (JAK) inhibitor.

- Prior bDMARD therapy has to be washed out.

- Participant must not have a history of an allergic reaction or significant sensitivity
to constituents of the study drug.

All the cities where the clinical studies are located

Edmonton - T6G 2B7

Victoria - V8V 3M9

Toronto - M5T 2S8

Montréal - H4A 3T2

Quebec - G1R 3S2

Trois-rivières - G8Z 1Y2

Alberta

British Columbia

Ontario