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Study Estimating the Clinical Difference Between 300 mg and 150 mg of Secukinumab Following Dose Escalation to 300 mg in Patients With Ankylosing Spondylitis

NCT03350815 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 322

Last updated 2022-04-29

Study results available
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Summary

This was a study estimating the clinical difference between 300 mg and 150 mg of secukinumab following dose escalation to 300 mg in patients with ankylosing spondylitis

Conditions

Interventions

DRUG

150 mg open-label secukinumab

All patients in Treatment Period 1 received 150 mg s.c. injection open-label secukinumab.

DRUG

150 mg double-blinded secukinumab

Treatment Period 2 Patients who achieved responder status entered Treatment Period 2 and continued to receive 150 mg s.c. (1 s.c. injection of secukinumab 150 mg)

DRUG

300 mg double-blinded secukinumab

Treatment Period 2 300 mg (2 s.c. injections of the 150 mg dose)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-13
Primary Completion
2021-03-11
Completion
2021-05-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT03350815 on ClinicalTrials.gov