NCT03704428

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 12, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2020

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2018

Enrollment Period

1.7 years

First QC Date

September 24, 2018

Last Update Submit

January 11, 2021

Conditions

Axial Spondyloarthritis

Keywords

SHR1314

Outcome Measures

Primary Outcomes (1)

  • 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. 1. Incidence of Treatment-Emergent Adverse Events 2. Incidence of Injection site reaction

    Baseline to 169 days after dose administration

Secondary Outcomes (5)

  • Maximum observed serum concentration (Cmax) of SHR-1314

    Baseline to 169 days after dose administration

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

    Baseline to 169 days after dose administration

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

    Baseline to 169 days after dose administration

  • Assessment of development of Anti-drug Antibodies (ADAs)

    Baseline to 169 days after dose administration

  • Proportion of Participants Achieving an ASAS20 Response

    Week2, 4, 6, 8, 12,16

Study Arms (5)

Cohort 1

EXPERIMENTAL

Multiple subcutaneous injections of SHR-1314 dose 1

Drug: SHR-1314

Cohort 2

EXPERIMENTAL

Multiple subcutaneous injections of SHR-1314 dose 2

Drug: SHR-1314

Cohort 3

EXPERIMENTAL

Multiple subcutaneous injections of SHR-1314 dose 3

Drug: SHR-1314

Cohort 4

EXPERIMENTAL

Multiple subcutaneous injections of SHR-1314 dose 4

Drug: SHR-1314

Cohort 5

EXPERIMENTAL

Multiple subcutaneous injections of SHR-1314 dose 5

Drug: SHR-1314

Interventions

SHR-1314DRUG

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

Also known as: Placebo
Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jianwen Chen

Shanghai, China

Location

MeSH Terms

Conditions

Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Study Officials

  • Fei Sun, MD

    People's Liberation Army General Hospital

    PRINCIPAL INVESTIGATOR

  • Xin Chang, MD

    The First Affiliated Hospital of Soochow University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2018

First Posted

October 12, 2018

Study Start

April 19, 2018

Primary Completion

January 14, 2020

Study Completion

January 14, 2020

Last Updated

January 13, 2021

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)