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A Study of Brodalumab in Subjects With Axial Spondyloarthritis (axSpA)

NCT02985983 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2024-07-16

No results posted yet for this study

Summary

To evaluate the efficacy of Brodalumab in axSpA (ankylosing spondylitis \[AS\] and non-radiographic axial spondyloarthritis \[nr-axSpA\]) subjects compared to placebo, as measured by the proportion of axSpA subjects achieving an Assessment of SpondyloArthritis international Society (ASAS) 40 response at week 16.

Conditions

  • Axial Spondyloarthritis

Interventions

DRUG

Brodalumab

Administered Brodalumab by subcutaneous (SC) injection until week 66.

DRUG

Placebo

Administered Placebo by subcutaneous (SC) injection until week 16. Administered Brodalumab by SC injection from week 17 until week 66.

Sponsors & Collaborators

  • Kyowa Kirin Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-07
Primary Completion
2019-09-23
Completion
2019-09-23

Countries

  • Japan
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

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 NCT02985983 on ClinicalTrials.gov