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Monoclonal Antibodies

Secukinumab for Rotator Cuff Tendinopathy

Verified Trial
Phase 3
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unilateral rotator cuff tendinopathy with ≥ 6 weeks to ≤ 6 months symptom duration at BSL.
Nocturnal pain in shoulder on at least 3 out of 7 nights in the week prior to Baseline or "positive painful arc test" on examination.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and weeks 4 and 16
Awards & highlights

Summary

This trial tests whether secukinumab injections can help people with severe shoulder tendon issues who haven't improved with usual treatments. The medication aims to reduce inflammation and pain, improving shoulder function. Participants will receive the medication along with their regular care to see if the new treatment works better.

Who is the study for?
This trial is for people with moderate to severe rotator cuff tendinopathy lasting between 6 weeks and 6 months. Participants must have tried NSAIDs, physiotherapy, and show specific MRI findings without a full tear in the tendon. They can't join if they've used corticosteroids recently, have other inflammatory diseases like rheumatoid arthritis or lupus, or can't undergo an MRI.
What is being tested?
The study tests Secukinumab against a placebo in improving symptoms and physical function in those with rotator cuff tendinopathy. It's randomized and double-blind to ensure fairness and eliminate bias; both treatments are given alongside standard care.
What are the potential side effects?
Secukinumab may cause side effects such as infections due to weakened immune response, allergic reactions at the injection site, headache, upper respiratory tract infections, runny nose or sore throat (nasopharyngitis), diarrhea, sinusitis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and weeks 4 and 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and weeks 4 and 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from BSL in in the Western Ontario Rotator Cuff Index (WORC) Physical Symptom Domain (PSD) score
Secondary study objectives
Change from BSL in the Patient-Reported Outcomes Measurement Information System (PROMIS) - Short Form (SF) Upper Extremity score
Incidence of binding and neutralizing Anti-drug antibodies
Proportion of participants who achieve an improvement (increase) of at least 40 points from BSL in the WORC PSD
+4 more

Side effects data

From 2019 Phase 4 trial • 102 Patients • NCT03055494
19%
Nasopharyngitis
13%
Upper respiratory tract infection
7%
Cough
7%
Back pain
6%
Headache
4%
Urinary tract infection
4%
Muscle strain
4%
Anxiety
4%
Rhinorrhoea
4%
Sinus congestion
4%
Postoperative wound infection
4%
Conjunctivitis
4%
Pharyngitis streptococcal
4%
Gastroenteritis viral
4%
Diarrhoea
4%
Fatigue
4%
Aphthous ulcer
4%
Influenza
4%
Fall
2%
Insomnia
2%
Hypoglycaemia
2%
Actinic keratosis
2%
Tooth abscess
2%
Post procedural contusion
2%
Road traffic accident
2%
Ligament sprain
2%
Blood pressure increased
2%
Wound dehiscence
2%
Tinea pedis
2%
Tonsillitis
2%
Ligament rupture
2%
Oropharyngeal pain
2%
Productive cough
2%
Dermatitis
2%
Pruritus
2%
Dehydration
2%
Squamous cell carcinoma
2%
Irritability
2%
Sneezing
2%
Intertrigo
2%
Pruritus generalised
2%
Decreased appetite
2%
Nasal congestion
2%
Sinusitis
2%
Palpitations
2%
Glossodynia
2%
Cyst
2%
Cystitis
2%
Otitis externa candida
2%
Peripheral swelling
2%
Hordeolum
2%
Otitis media
2%
Ear pain
2%
Anaemia
2%
Cellulitis
2%
Suicidal ideation
2%
Lacrimation increased
2%
Muscle spasms
2%
Ear discomfort
2%
Pyrexia
2%
Abdominal distension
2%
Nausea
2%
Toothache
2%
Myalgia
2%
Influenza like illness
2%
Rash
2%
Seborrhoeic dermatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Secukinumab 300 mg
Placebo/Secukinumab 300 mg

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SecukinumabExperimental Treatment1 Intervention
Name and Strength: 2 X Secukinumab 150 mg / 1 mL Pharmaceutical Dosage Form: Solution for subcutaneous (s.c.) injection Randomized in a 1:1 ratio
Group II: PlaceboPlacebo Group1 Intervention
Name and Strength: 2 X Placebo / 1 mL Pharmaceutical Dosage Form: Solution for subcutaneous (s.c.) injection Randomized in a 1:1 ratio
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Secukinumab
2015
Completed Phase 4
~22170

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Rotator Cuff Tendinopathy is often treated by targeting inflammation and modulating the immune response. Secukinumab, an IL-17A inhibitor, works by blocking the activity of interleukin-17A, a cytokine involved in inflammatory processes. This inhibition reduces inflammation and can alleviate pain and improve physical function in patients. Other common treatments include corticosteroids, which reduce inflammation by suppressing the immune system, and physical therapy, which aims to strengthen the muscles around the shoulder to reduce strain on the tendons. Understanding these mechanisms is crucial for patients as it helps them comprehend how these treatments can reduce symptoms and improve their quality of life.

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Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,889 Previous Clinical Trials
4,201,770 Total Patients Enrolled
~31 spots leftby Nov 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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