NCT04840485

Brief Summary

The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SHR-1314 in patients with active ankylosing spondylitis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
548

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2021

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

First Submitted

Initial submission to the registry

April 7, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 12, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 9, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

May 22, 2024

Status Verified

May 1, 2024

Enrollment Period

2.4 years

First QC Date

April 7, 2021

Last Update Submit

May 21, 2024

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Responded for Assessment of SpondyloArthritis international Society 20 Criteria (ASAS20) at 16 Weeks

    16 Weeks

Secondary Outcomes (5)

  • Percentage of Participants Responded for ASAS 20 Response at 32 Weeks

    32 Weeks

  • Percentage of Participants Responded for ASAS 40 Response at 16 and 32 Weeks

    16 and 32 Weeks

  • Percentage of Participants Responded for ASAS 5/6 Response at 16 and 32 Weeks

    16 and 32 Weeks

  • Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 16 and 32 Weeks

    16 and 32 Weeks

  • Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at 16 and 32 Weeks

    16 and 32 Weeks

Study Arms (3)

Treatment group A

EXPERIMENTAL
Drug: SHR-1314

Treatment group B

EXPERIMENTAL
Drug: SHR-1314

Treatment group C

PLACEBO COMPARATOR
Drug: Placebo

Interventions

SHR-1314DRUG

SHR-1314 high dose

Treatment group A
PlaceboDRUG

Placebo

Treatment group C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Active Ankylosing Spondylitis, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response, contraindications or intolerance to NSAIDs

You may not qualify if:

  • \- pregnancy or lactation, serious infectious, malignancy, previous exposure to any biological agent excluding TNF antagonists

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2021

First Posted

April 12, 2021

Study Start

June 9, 2021

Primary Completion

November 3, 2023

Study Completion

February 28, 2024

Last Updated

May 22, 2024

Record last verified: 2024-05

Locations

CN(1)