Back to results

Safety, Tolerability and PK of SHR1314 in axSpA

Primary Purpose

Axial Spondyloarthritis

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

SHR-1314

About this trial

This is an interventional treatment trial for Axial Spondyloarthritis focused on measuring SHR1314

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of axial spondyloarthritis (axSpA) and fulfilling the 2009 ASAS classification criteria.
Have a history of back pain ≥3 months with age at onset <45 years.
Have active axSpA defined as BASDAI ≥4 at screening and baseline.
Have objective signs of inflammation by presence of elevated ESR and/or presence of elevated CRP.
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.
If taking NSAIDS be on stable dose for at least 2 weeks prior to randomization.

Exclusion Criteria:

History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection.
Previous exposure to other biologic drug directly targeting Interleukin (IL)-17 or Interleukin (IL)-17 receptor.
Total ankylosis of the spine.
Have recently received biologics, tumor necrosis factor inhibitors or other immunomodulatory agents within 12 weeks.
Have either a current diagnosis or a recent history of malignant disease.
Are pregnant or breastfeeding.

Sites / Locations

Jianwen Chen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Arm Description

Multiple subcutaneous injections of SHR-1314 dose 1

Multiple subcutaneous injections of SHR-1314 dose 2

Multiple subcutaneous injections of SHR-1314 dose 3

Multiple subcutaneous injections of SHR-1314 dose 4

Multiple subcutaneous injections of SHR-1314 dose 5

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Maximum observed serum concentration (Cmax) of SHR-1314

maximum concentration (Cmax)

Time to maximum observed serum concentration (tmax) of SHR-1314

Time to maximum concentration (Tmax)

Time to elimination half-life (t1/2) of SHR-1314

t1/2

Assessment of development of Anti-drug Antibodies (ADAs)

Incidence of development of Anti-drug Antibodies (ADAs)

Proportion of Participants Achieving an ASAS20 Response

ASAS20 Response

Full Information

NCT ID

NCT03704428

First Posted

September 24, 2018

Last Updated

January 11, 2021

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03704428

Brief Title

Safety, Tolerability and PK of SHR1314 in axSpA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

April 19, 2018 (Actual)

Primary Completion Date

January 14, 2020 (Actual)

Study Completion Date

January 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Axial Spondyloarthritis

Keywords

SHR1314

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Description

Multiple subcutaneous injections of SHR-1314 dose 1

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

Multiple subcutaneous injections of SHR-1314 dose 2

Arm Title

Cohort 3

Arm Type

Experimental

Arm Description

Multiple subcutaneous injections of SHR-1314 dose 3

Arm Title

Cohort 4

Arm Type

Experimental

Arm Description

Multiple subcutaneous injections of SHR-1314 dose 4

Arm Title

Cohort 5

Arm Type

Experimental

Arm Description

Multiple subcutaneous injections of SHR-1314 dose 5

Intervention Type

Drug

Intervention Name(s)

SHR-1314

Other Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Description

Time Frame

Baseline to 169 days after dose administration

Secondary Outcome Measure Information:

Title

Maximum observed serum concentration (Cmax) of SHR-1314

Description

maximum concentration (Cmax)

Time Frame

Baseline to 169 days after dose administration

Title

Time to maximum observed serum concentration (tmax) of SHR-1314

Description

Time to maximum concentration (Tmax)

Time Frame

Baseline to 169 days after dose administration

Title

Time to elimination half-life (t1/2) of SHR-1314

Description

t1/2

Time Frame

Baseline to 169 days after dose administration

Title

Assessment of development of Anti-drug Antibodies (ADAs)

Description

Incidence of development of Anti-drug Antibodies (ADAs)

Time Frame

Baseline to 169 days after dose administration

Title

Proportion of Participants Achieving an ASAS20 Response

Description

ASAS20 Response

Time Frame

Week2, 4, 6, 8, 12,16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of axial spondyloarthritis (axSpA) and fulfilling the 2009 ASAS classification criteria. Have a history of back pain ≥3 months with age at onset <45 years. Have active axSpA defined as BASDAI ≥4 at screening and baseline. Have objective signs of inflammation by presence of elevated ESR and/or presence of elevated CRP. 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. If taking NSAIDS be on stable dose for at least 2 weeks prior to randomization. Exclusion Criteria: History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection. Previous exposure to other biologic drug directly targeting Interleukin (IL)-17 or Interleukin (IL)-17 receptor. Total ankylosis of the spine. Have recently received biologics, tumor necrosis factor inhibitors or other immunomodulatory agents within 12 weeks. Have either a current diagnosis or a recent history of malignant disease. Are pregnant or breastfeeding.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fei Sun, MD

Organizational Affiliation

People's Liberation Army General Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Xin Chang, MD

Organizational Affiliation

The First Affiliated Hospital of Soochow University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jianwen Chen

City

Shanghai

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Safety, Tolerability and PK of SHR1314 in axSpA

We'll reach out to this number within 24 hrs