Safety, Tolerability and PK of SHR1314 in axSpA

January 11, 2021 updated by: Jiangsu HengRui Medicine Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Jianwen Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 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
Baseline to 169 days after dose administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum observed serum concentration (Cmax) of SHR-1314
Time Frame: Baseline to 169 days after dose administration
maximum concentration (Cmax)
Baseline to 169 days after dose administration
Time to maximum observed serum concentration (tmax) of SHR-1314
Time Frame: Baseline to 169 days after dose administration
Time to maximum concentration (Tmax)
Baseline to 169 days after dose administration
Time to elimination half-life (t1/2) of SHR-1314
Time Frame: Baseline to 169 days after dose administration
t1/2
Baseline to 169 days after dose administration
Assessment of development of Anti-drug Antibodies (ADAs)
Time Frame: Baseline to 169 days after dose administration
Incidence of development of Anti-drug Antibodies (ADAs)
Baseline to 169 days after dose administration
Proportion of Participants Achieving an ASAS20 Response
Time Frame: Week2, 4, 6, 8, 12,16
ASAS20 Response
Week2, 4, 6, 8, 12,16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu HengRui Medicine Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 19, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 14, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 14, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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