A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Ankylosing Spondylitis

NCT04481139 | Completed Phase 2 DMC

• 1 other identifier: SHR0302-302
• Study Type: interventional
• Target: 504
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the efficacy and safety of different doses of JAK1 inhibitor SHR0302 in subjects with active ankylosing spondylitis.

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 12.

  ASAS20 is defined as a \>= 20% improvement and an absolute improvement of \>= 1 units (on a scale of 0 to 10) from Baseline in at least 3 of the 4 domains (patient's global assessment, back pain, function and inflammation) with no deterioration in the remaining domain (where deterioration is defined as a worsening of \>= 20% and a net worsening of \>= 1 unit \[on a scale of 0 to 10\])

  Week 12

Secondary Outcomes (8)

• Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 24.

  Week 24

• Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 40 response at Week 12 and Week 24.

  Week 12 and Week 24

• Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 5/6 response at Week 12 and Week 24.

  Week 12 and Week 24

• Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  Week 12 and Week 24

• Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12 and Week 24.

  Week 12 and Week 24

Study Arms (4)

SHR0302 dose1

EXPERIMENTAL

SHR0302 dose1 for 24 weeks

Drug: SHR0302

SHR0302 dose2

EXPERIMENTAL

SHR0302 dose2 for 24 weeks

Drug: SHR0302

SHR0302 dose3

EXPERIMENTAL

SHR0302 dose3 for 24 weeks

Drug: SHR0302

Placebo

PLACEBO COMPARATOR

Placebo for 12 weeks

Drug: SHR0302 placebo

Interventions

SHR0302 DRUG

SHR0302, oral, once daily

SHR0302 dose1; SHR0302 dose2; SHR0302 dose3

SHR0302 placebo DRUG

SHR0302 placebo, oral, once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide signed informed consent.
• AS diagnosis consistent with the Modified New York Criteria for AS (1984);
• 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 subjects are taking permitted csDMARDs or low-dose corticosteroid orally at baseline , the stable doses should have lasted for more than 4 weeks already.
• BMI ≥18 kg/m2

You may not qualify if:

• Pregnant women or refuse to receive contraception during the study.
• Lab abnormality within 4 weeks of randomization as follows: WBC count \<3.0×10\^9/L；neutrophil count\<1.5×10\^9/L;hemoglobin level\<90.0 g/L ; platelet count \<100×10\^9/L; AST or ALT levels greater than the upper limit of normal; HBsAg or HCV or HIV antibody positivity.
• History of other autoimmune diseases ; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases.
• Previous treatment with JAK inhibitor or cytotoxic drugs; bDMARDs within 6 months of randomization; other strong immunosuppressants within 6 months of randomization.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Zhanguo Li

Beijing, Beijing Municipality, 100044, China

Location

Related Publications (1)

• Xu X, Wei H, Liu L, Yang R, Shi Q, Pang D. Ivarmacitinib improves patient-reported outcomes across multiple domains in patients with active ankylosing spondylitis: a post hoc analysis of a phase II/III trial. Front Pharmacol. 2025 Nov 20;16:1710434. doi: 10.3389/fphar.2025.1710434. eCollection 2025.

  PMID: 41357869 DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

ivarmacitinib

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 22, 2020
• Study Start: October 14, 2020
• Primary Completion: November 15, 2022
• Study Completion: May 12, 2023
• Last Updated: July 27, 2023

Record last verified: 2022-07

Locations

CN (1)