A randomized, parallel-group, 24 week, double-blind, placebo-controlled, multicenter Phase 3 study to assess the efficacy and safety of secukinumab compared to placebo in adult patients with active rotator cuff tendinopathy

Conditions

Moderate to severe rotator cuff tendinopathy

Brief summary

Change from Baseline (BSL) in the Western Ontario Rotator Cuff Index (WORC) Physical Symptom Domain (PSD) score at Week 16

Detailed description

Proportion of participants who achieve an improvement (increase) of at least 40 points from BSL in WORC PSD at Week 16, Proportion of participants receiving AIN457 compared to placebo who achieve an increase of 50 points in WORC Total score at Week 16, Change from BSL in Patient-Reported Outcomes Measurement Information System (PROMIS) - Short Form (SF) Upper Extremity score at Week 16, Proportion of participants who achieve an improvement (increase) of at least 40 points from BSL in WORC PSD at Week 24 Change from BSL in WORC PSD at Week 24, Secukinumab serum concentrations on Day 1 and Weeks 4 and 16, Safety and tolerability demonstrated by assessing: AEs and SAEs (incidence, severity, and relationship with study drug) Incidence of clinically significant changes in laboratory parameters and vital signs Incidence of binding and neutralizing anti-drug antibodies (ADAs) at Day 1 and Week 16

Related papers

No related papers found yet.

Interventions

DRUG-

DRUGPlacebo to AIN457 150mg/1mL Solution for injection in pre-filled syringe

DRUGSECUKINUMAB

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Change from Baseline (BSL) in the Western Ontario Rotator Cuff Index (WORC) Physical Symptom Domain (PSD) score at Week 16	—

Secondary

Measure	Time frame
Proportion of participants who achieve an improvement (increase) of at least 40 points from BSL in WORC PSD at Week 16, Proportion of participants receiving AIN457 compared to placebo who achieve an increase of 50 points in WORC Total score at Week 16, Change from BSL in Patient-Reported Outcomes Measurement Information System (PROMIS) - Short Form (SF) Upper Extremity score at Week 16, Proportion of participants who achieve an improvement (increase) of at least 40 points from BSL in WORC PSD at Week 24 Change from BSL in WORC PSD at Week 24, Secukinumab serum concentrations on Day 1 and Weeks 4 and 16, Safety and tolerability demonstrated by assessing: AEs and SAEs (incidence, severity, and relationship with study drug) Incidence of clinically significant changes in laboratory parameters and vital signs Incidence of binding and neutralizing anti-drug antibodies (ADAs) at Day 1 and Week 16	—

Measure

Time frame

Proportion of participants who achieve an improvement (increase) of at least 40 points from BSL in WORC PSD at Week 16, Proportion of participants receiving AIN457 compared to placebo who achieve an increase of 50 points in WORC Total score at Week 16, Change from BSL in Patient-Reported Outcomes Measurement Information System (PROMIS) - Short Form (SF) Upper Extremity score at Week 16, Proportion of participants who achieve an improvement (increase) of at least 40 points from BSL in WORC PSD at Week 24 Change from BSL in WORC PSD at Week 24, Secukinumab serum concentrations on Day 1 and Weeks 4 and 16, Safety and tolerability demonstrated by assessing: AEs and SAEs (incidence, severity, and relationship with study drug) Incidence of clinically significant changes in laboratory parameters and vital signs Incidence of binding and neutralizing anti-drug antibodies (ADAs) at Day 1 and Week 16

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Countries

Bulgaria, Czechia, Denmark, France, Portugal, Slovakia

Outcome results

None listed