Safety, Tolerability and PK of SHR1314 in axSpA

• Status: Completed
• Trial end date: 2020-01-14
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to evaluate the safety, Tolerability and Pharmacokinetics (PK) of SHR1314 with axial spondyloarthritis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

Inclusion Criteria:

1. Diagnosis of axial spondyloarthritis (axSpA) and fulfilling the 2009 ASAS classification criteria.

2. Have a history of back pain ≥3 months with age at onset <45 years.

3. Have active axSpA defined as BASDAI ≥4 at screening and baseline.

4. Have objective signs of inflammation by presence of elevated ESR and/or presence of elevated CRP.

5. In the past had an inadequate response to at least 1 or 2 non-steroidal anti-inflammatory drugs (NSAIDS) for duration of 4 weeks or cannot tolerate NSAIDS.

6. If taking NSAIDS be on stable dose for at least 2 weeks prior to randomization.

Exclusion Criteria:

1. History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection.

2. Previous exposure to other biologic drug directly targeting Interleukin (IL)-17 or Interleukin (IL)-17 receptor.

3. Total ankylosis of the spine.

4. Have recently received biologics, tumor necrosis factor inhibitors or other immunomodulatory agents within 12 weeks.

5. Have either a current diagnosis or a recent history of malignant disease.

6. Are pregnant or breastfeeding.