Safety, Tolerability and PK of SHR1314 in axSpA

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, MAD Study to Evaluation of Safety, Tolerability and PK of SHR1314 With Axial Spondyloarthritis

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

Study Overview

• Status: Completed
• Conditions: Axial Spondyloarthritis
• Intervention / Treatment: Drug: SHR-1314

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Jianwen Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Multiple subcutaneous injections of SHR-1314 dose 1	Drug: SHR-1314; Pharmaceutical form: Injection solution. Route of administration: subcutaneous injection.; Other Names: Placebo
Experimental: Cohort 2; Multiple subcutaneous injections of SHR-1314 dose 2	Drug: SHR-1314; Pharmaceutical form: Injection solution. Route of administration: subcutaneous injection.; Other Names: Placebo
Experimental: Cohort 3; Multiple subcutaneous injections of SHR-1314 dose 3	Drug: SHR-1314; Pharmaceutical form: Injection solution. Route of administration: subcutaneous injection.; Other Names: Placebo
Experimental: Cohort 4; Multiple subcutaneous injections of SHR-1314 dose 4	Drug: SHR-1314; Pharmaceutical form: Injection solution. Route of administration: subcutaneous injection.; Other Names: Placebo
Experimental: Cohort 5; Multiple subcutaneous injections of SHR-1314 dose 5	Drug: SHR-1314; Pharmaceutical form: Injection solution. Route of administration: subcutaneous injection.; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Safety and tolerability of multiple subcutaneous injections of SHR1314 assessed by adverse events and serious adverse events.; Incidence of Treatment-Emergent Adverse Events; Incidence of Injection site reaction	Baseline to 169 days after dose administration

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Principal Investigator: Fei Sun, MD, People's Liberation Army General Hospital; Principal Investigator: Xin Chang, MD, the First Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2018
• Primary Completion (Actual): January 14, 2020
• Study Completion (Actual): January 14, 2020

Study Registration Dates

• First Submitted: September 24, 2018
• First Submitted That Met QC Criteria: October 10, 2018
• First Posted (Actual): October 12, 2018

Study Record Updates

• Last Update Posted (Actual): January 13, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: SHR1314
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Spondylitis; Spondylarthritis
• Other Study ID Numbers: SHR-1314-AS-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No