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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 tests how well secukinumab helps improve signs, symptoms and physical function in people with rotator cuff tendinopathy.

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.Check my eligibility
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.See study design
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

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
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%
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
2,859 Previous Clinical Trials
4,198,010 Total Patients Enrolled

Frequently Asked Questions

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

Has Secukinumab been given sanction by the Food and Drug Administration?

"We rate secukinumab's safety at a 3 due to its Phase 3 clinical trial status, which implies significant evidence backing both the treatment's effectiveness and security."

Answered by AI

Is enrollment for this clinical trial open to individuals below the age of fourty?

"Eligibility for this clinical trial mandates that applicants are between 18 to 65 years old. Alternatively, there is a separate set of 3 trials available for those under the age of consent and 57 studies open to seniors aged over 65."

Answered by AI

Are there many venues in the U.S. that are executing this trial?

"Currently, this medical trial is being conducted at 13 distinct locations. These sites are located in Tucson, El Cajon and Bradenton as well as other cities around the country. To keep travel to a minimum for participants, it is recommended that they select the closest available site."

Answered by AI

How many participants can take part in this experiment?

"Indeed, the information displayed on clinicaltrials.gov states that this medical study is actively recruiting patients. It was initially posted in August 10th of 2023 and its most recent update took place on September 19th, 2023. The aim is to enroll 234 people across thirteen different sites."

Answered by AI

Are there any available positions for individuals to participate in this research?

"Clinicaltrials.gov denotes that this study is currently recruiting participants. The trial was posted on August 10th 2023 and has since received an update during September 19th of the same year."

Answered by AI

What is the requisite for enrolling in this research project?

"This clinical trial is enlisting 234 people, aged 18-65, that have been diagnosed with rotator cuff tendinopathy. Those interested must additionally satisfy the following criteria: Unilateral shoulder condition of 6 weeks to 6 months' duration at Baseline; Nocturnal pain in their shoulder on 3 or more nights during the week prior to initial visit; Total WORC score not exceeding 40 points as measured at Screening and Baseline visits; An average weekly numerical rating scale (NRS) sore higher than 5 over preceding 7 days before Baseline assessment; Resistant to standard therapy methodologies such as NSAIDs and physical therapy for 8 weeks without"

Answered by AI

Who else is applying?

What site did they apply to?
Novartis Investigative Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met 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/NCT05722522.
~109 spots leftby Nov 2024
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