Efficacy and Safety of IBI303 in Adult Patients With Active Ankylosing Spondylitis

NCT02893254 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 438

Last updated 2018-06-04

No results posted yet for this study

Summary

Study of the efficacy and safety of IBI303 compared with adalimumab in adult patients with ankylosing spondylitis (AS) who have had an inadequate response to or who are intolerant to one or more nonsteroidal anti-inflammatory drugs (NSAIDs)

Conditions

  • AS

Interventions

DRUG

IBI303

12 cycles. IBI303: 40 mg, iH

DRUG

Adalimumab

12 cycles. Adalimumab: 40mg, iH

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Huji Xu · Shanghai Changzheng Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-22
Primary Completion
2018-01-22
Completion
2018-03-16

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02893254 on ClinicalTrials.gov