Safety, Tolerability and PK of SHR1314 in axSpA

Phase 1

Completed

• Conditions: Axial Spondyloarthritis
• Interventions: Drug: SHR-1314

• Registration Number: NCT03704428
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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).

Study Timeline

• Status Verified: 2018-01
• Study Start: 2018-04-19
• Study First Submitted: 2018-09-24
• Study First Submitted QC: 2018-10-10
• Study First Posted: 2018-10-12
• Primary Completion: 2020-01-14
• Study Completion: 2020-01-14
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 1	SHR-1314	Multiple subcutaneous injections of SHR-1314 dose 1
Cohort 4	SHR-1314	Multiple subcutaneous injections of SHR-1314 dose 4
Cohort 2	SHR-1314	Multiple subcutaneous injections of SHR-1314 dose 2
Cohort 3	SHR-1314	Multiple subcutaneous injections of SHR-1314 dose 3
Cohort 5	SHR-1314	Multiple subcutaneous injections of SHR-1314 dose 5

Primary Outcome Measures

Name	Time	Method
The safety and tolerability of multiple subcutaneous injections of SHR1314 in adult patients with axial spondyloarthritis 1.Incidence of Treatment-Emergent Adverse Events 2.Incidence of Injection site reaction	Baseline to 169 days after dose administration	Safety and tolerability of multiple subcutaneous injections of SHR1314 assessed by adverse events and serious adverse events.; 1. Incidence of Treatment-Emergent Adverse Events; 2. Incidence of Injection site reaction

Secondary Outcome Measures

Name	Time	Method
Time to elimination half-life (t1/2) of SHR-1314	Baseline to 169 days after dose administration	t1/2
Proportion of Participants Achieving an ASAS20 Response	Week2, 4, 6, 8, 12,16	ASAS20 Response
Time to maximum observed serum concentration (tmax) of SHR-1314	Baseline to 169 days after dose administration	Time to maximum concentration (Tmax)
Maximum observed serum concentration (Cmax) of SHR-1314	Baseline to 169 days after dose administration	maximum concentration (Cmax)
Assessment of development of Anti-drug Antibodies (ADAs)	Baseline to 169 days after dose administration	Incidence of development of Anti-drug Antibodies (ADAs)

Trial Locations

Locations (1)

Jianwen Chen; 🇨🇳 Shanghai, China