Safety, Tolerability and PK of SHR1314 in axSpA

NCT ID: NCT03704428

Last Updated: 2021-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-19
• Study Completion Date: 2020-01-14

Brief Summary

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

Detailed 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).

Conditions

Axial Spondyloarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1

Multiple subcutaneous injections of SHR-1314 dose 1

Group Type: EXPERIMENTAL

SHR-1314

Intervention Type: DRUG

Pharmaceutical form: Injection solution. Route of administration: subcutaneous injection.

Cohort 2

Multiple subcutaneous injections of SHR-1314 dose 2

Group Type: EXPERIMENTAL

SHR-1314

Intervention Type: DRUG

Pharmaceutical form: Injection solution. Route of administration: subcutaneous injection.

Cohort 3

Multiple subcutaneous injections of SHR-1314 dose 3

Group Type: EXPERIMENTAL

SHR-1314

Intervention Type: DRUG

Pharmaceutical form: Injection solution. Route of administration: subcutaneous injection.

Cohort 4

Multiple subcutaneous injections of SHR-1314 dose 4

Group Type: EXPERIMENTAL

SHR-1314

Intervention Type: DRUG

Pharmaceutical form: Injection solution. Route of administration: subcutaneous injection.

Cohort 5

Multiple subcutaneous injections of SHR-1314 dose 5

Group Type: EXPERIMENTAL

SHR-1314

Intervention Type: DRUG

Pharmaceutical form: Injection solution. Route of administration: subcutaneous injection.

Interventions

SHR-1314

Pharmaceutical form: Injection solution. Route of administration: subcutaneous injection.

Intervention Type: DRUG

Other Intervention Names

Placebo

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fei Sun, MD

Role: PRINCIPAL_INVESTIGATOR

People's Liberation Army General Hospital

Xin Chang, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Soochow University

Locations

Jianwen Chen

Shanghai, , China

Countries

China

Other Identifiers

SHR-1314-AS-102

Identifier Type: -

Identifier Source: org_study_id