NCT03344640

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

A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase II, 24-week Study Investigating the Efficacy, Safety and Tolerability of AIN457 in Patients With Active Overuse Tendinopathy Refractory to Oral NSAIDs/Acetaminophen, Physiotherapy or Corticosteroid Injections

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 and refractory to NSAIDs/acetaminophen, physiotherapy or corticosteroids. The study consisted of a 4-week screening period, a 2-week run-in period, a 12-week treatment period and a 12-week follow-up period after last treatment. The population consisted of patients with unilateral overuse (non-systemic inflammatory) shoulder tendinopathy, 18 - 65 years of age. Safety assessments included physical examinations, ECGs, vital signs, standard clinical laboratory evaluations (hematology, blood chemistry, and urinalysis), adverse event and serious adverse event monitoring.

Conditions

• Tendinopathy

Interventions

Type	Name	Description
DRUG	secukinumab	AIN457 300 mg subcutaneously for 12 weeks
OTHER	Placebo	Placebo to match AIN457 subcutaneously for 12 weeks

Timeline

• Start date: 2017-12-15
• Primary completion: 2019-08-02
• Completion: 2019-10-17
• First posted: 2017-11-17
• Last updated: 2021-10-08
• Results posted: 2020-12-09

Locations

12 sites across 5 countries: United States, Czechia, Germany, Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study