Safety, Tolerability and PK of SHR1314 in axSpA

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Axial Spondyloarthritis

Treatments: Drug: SHR-1314

Study type: Interventional

Funder types: Industry

Identifiers

NCT03704428

SHR-1314-AS-102

Details and patient eligibility

About

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

Full description

This was a phase I, multicenter, double-blind, randomized, placebo-controlled study. The study originally planned to enroll 5 cohorts of 8 subjects each (N=40).

Enrollment: 45 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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45 participants in 5 patient groups

Cohort 1

Experimental group

Description:

Multiple subcutaneous injections of SHR-1314 dose 1

Treatment:

Drug: SHR-1314

Cohort 2

Experimental group

Description:

Multiple subcutaneous injections of SHR-1314 dose 2

Treatment:

Drug: SHR-1314

Cohort 3

Experimental group

Description:

Multiple subcutaneous injections of SHR-1314 dose 3

Treatment:

Drug: SHR-1314

Cohort 4

Experimental group

Description:

Multiple subcutaneous injections of SHR-1314 dose 4

Treatment:

Drug: SHR-1314

Cohort 5

Experimental group

Description:

Multiple subcutaneous injections of SHR-1314 dose 5

Treatment:

Drug: SHR-1314