Study of Efficacy, Safety and Tolerability of AIN457 in Patients With Active Overuse Tendinopathy

NCT03344640 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2021-10-08

Study results available
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Summary

This was a randomized, double-blind, placebo-controlled, multi-center, Phase II study of s.c. secukinumab 300 mg in 98 randomized patients with overuse rotator-cuff tendinopathy without systemic inflammatory disease.

Conditions

  • Tendinopathy

Interventions

DRUG

secukinumab

AIN457 300 mg subcutaneously for 12 weeks

OTHER

Placebo

Placebo to match AIN457 subcutaneously for 12 weeks

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-12-15
Primary Completion
2019-08-02
Completion
2019-10-17
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Germany
  • Netherlands
  • United Kingdom

Study Locations

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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 NCT03344640 on ClinicalTrials.gov