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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

Study Summary

This trial assesses if secukinumab can help improve signs, symptoms and physical function of people with moderate to severe rotator cuff tendinopathy.

Who is the study for?
This trial is for people with moderate to severe rotator cuff tendinopathy who've had symptoms for 6 weeks to 6 months and haven't improved after NSAIDs and physiotherapy. They must have a specific level of pain, no major tears in the tendon as confirmed by MRI, and agree to stick with their current treatment regimen throughout the study.Check my eligibility
What is being tested?
The trial is testing Secukinumab against a placebo in participants with rotator cuff tendinopathy. Both groups will also receive standard care treatments. The goal is to see if Secukinumab can better improve symptoms, physical function, and overall shoulder health compared to a placebo.See study design
What are the potential side effects?
Secukinumab may cause side effects such as infections due to lowered immunity, allergic reactions at the injection site like redness or pain, headache, diarrhea, upper respiratory tract infection symptoms (like sore throat), and possibly others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had shoulder tendon pain for 6 weeks to 6 months.
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I have had shoulder pain at night for at least 3 nights last week or a positive painful arc test.
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My average pain level was 5 or higher last week.
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I have tried NSAIDs and physiotherapy for 8 weeks without improvement.
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My MRI shows a shoulder tendon issue without a full tear.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from BSL in in the Western Ontario Rotator Cuff Index (WORC) Physical Symptom Domain (PSD) score
Secondary outcome measures
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
Number of participants with adverse events
+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%
Aphthous ulcer
4%
Sinus congestion
4%
Gastroenteritis viral
4%
Diarrhoea
4%
Conjunctivitis
4%
Fatigue
4%
Pharyngitis streptococcal
4%
Fall
4%
Influenza
4%
Muscle strain
4%
Urinary tract infection
4%
Postoperative wound infection
4%
Anxiety
4%
Rhinorrhoea
2%
Sneezing
2%
Rash
2%
Actinic keratosis
2%
Palpitations
2%
Abdominal distension
2%
Cyst
2%
Dermatitis
2%
Pruritus
2%
Ear pain
2%
Anaemia
2%
Lacrimation increased
2%
Suicidal ideation
2%
Toothache
2%
Peripheral swelling
2%
Pyrexia
2%
Ear discomfort
2%
Influenza like illness
2%
Nausea
2%
Cellulitis
2%
Glossodynia
2%
Otitis media
2%
Cystitis
2%
Intertrigo
2%
Ligament sprain
2%
Tooth abscess
2%
Road traffic accident
2%
Hordeolum
2%
Post procedural contusion
2%
Pruritus generalised
2%
Otitis externa candida
2%
Dehydration
2%
Tonsillitis
2%
Sinusitis
2%
Ligament rupture
2%
Tinea pedis
2%
Blood pressure increased
2%
Decreased appetite
2%
Hypoglycaemia
2%
Seborrhoeic dermatitis
2%
Wound dehiscence
2%
Insomnia
2%
Muscle spasms
2%
Myalgia
2%
Productive cough
2%
Squamous cell carcinoma
2%
Oropharyngeal pain
2%
Irritability
2%
Nasal congestion
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

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,860 Previous Clinical Trials
4,198,075 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial have any age restrictions, particularly for those over 20?

"This medical experiment requires that prospective patients are post-adolescent but below the age of retirement."

Answered by AI

How prevalent is this trial in North America?

"Seventeen cities are participating in this clinical trial, spanning from Tuscaloosa to Upland. To reduce travel obligations during the study, it is prudent to select a site close by for enrollment."

Answered by AI

Can any more participants join this research initiative?

"Affirmative. The information hosted on clinicaltrials.gov affirms that this medical study, which was initially announced on August 2nd 2023, is presently recruiting patients. A total of 234 participants need to be recruited from 17 different health care facilities."

Answered by AI

Can Secukinumab be used without causing undue harm to individuals?

"Our experts at Power assign a score of 3 to secukinumab's safety as this is Phase 3 trial, which reveals that there are multiple clinical trials supporting its efficacy and security."

Answered by AI

Am I eligible to register for this clinical trial?

"This medical trial seeks 234 participants aged 18-65 with rotator cuff tendinopathy that meet specific criteria. Patients should have nocturnal pain in their shoulder 3/7 nights prior to baseline or a positive painful arc test, and must be refractory to standard of care including NSAIDs (if not intolerant) and 8 weeks of physiotherapy. Additionally, the affected shoulder will need to show evidence of tendinopathy on MRI scan without any tears or partial tears exceeding 50% tendon thickness or 10mm AP length."

Answered by AI

What is the current capacity of this experiment?

"Affirmative. The details available on clinicaltrials.gov show that recruitment for this trial has been ongoing since August 2nd, 2023 and is still active today. In total, 234 participants are needed across 17 locations."

Answered by AI

Who else is applying?

What site did they apply to?
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Study of Efficacy and Safety of Secukinumab in Participants With Moderate-severe Rotator Cuff Tendinopathy
2023. "Study of Efficacy and Safety of Secukinumab in Participants With Moderate-severe Rotator Cuff Tendinopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05758415.
~102 spots leftby Dec 2024
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