What side effects are associated with this type of intervention?

Common treatments for Rotator Cuff Tendinopathy include nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections, physical therapy, and biologic therapies such as IL-17A inhibitors like Secukinumab. The known side effects of Secukinumab and similar IL-17A inhibitors can include mild to moderate injection site reactions (e.g., erythema, pain, or bruising), upper respiratory tract infections, headache, and fatigue. Serious adverse effects are rare but can include hypersensitivity reactions such as rash, pruritus, and urticaria. Overall, these treatments are generally well-tolerated, but patients should be monitored for any adverse reactions.

What prior FDA approvals exist?

There is no specific mention of prior FDA approvals for the treatment of Rotator Cuff Tendinopathy using IL-17A inhibitors like Secukinumab. Generally, treatments for Rotator Cuff Tendinopathy have included physical therapy, corticosteroid injections, and surgical interventions. Biologic agents, including IL-17A inhibitors, are being explored in clinical trials, but their use for this specific condition has not yet been established through FDA approval.

What other types of research exist?

Promising novel alternatives to Secukinumab for Rotator Cuff Tendinopathy patients in 2024 include: 1) Ustekinumab (IL-12/23 Inhibition), which has shown efficacy in ankylosing spondylitis and psoriatic arthritis. 2) Risankizumab (IL-23 Inhibition), which has demonstrated positive results in ankylosing spondylitis. 3) Tofacitinib (JAK Inhibition), which has been effective in psoriatic arthritis and other inflammatory conditions. These alternatives target similar inflammatory pathways and have shown promising results in related conditions.

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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

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 and weeks 4 and 16

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

Back pain

Cough

Headache

Urinary tract infection

Anxiety

Rhinorrhoea

Muscle strain

Postoperative wound infection

Sinus congestion

Conjunctivitis

Pharyngitis streptococcal

Gastroenteritis viral

Diarrhoea

Fatigue

Aphthous ulcer

Influenza

Fall

Ligament sprain

Insomnia

Oropharyngeal pain

Hypoglycaemia

Nasal congestion

Tinea pedis

Tooth abscess

Actinic keratosis

Irritability

Sneezing

Blood pressure increased

Wound dehiscence

Post procedural contusion

Road traffic accident

Pruritus

Pruritus generalised

Dermatitis

Dehydration

Tonsillitis

Ligament rupture

Squamous cell carcinoma

Productive cough

Decreased appetite

Intertrigo

Sinusitis

Palpitations

Glossodynia

Cyst

Cystitis

Otitis externa candida

Peripheral swelling

Hordeolum

Otitis media

Ear pain

Anaemia

Cellulitis

Suicidal ideation

Lacrimation increased

Muscle spasms

Ear discomfort

Pyrexia

Abdominal distension

Nausea

Toothache

Myalgia

Influenza like illness

Rash

Seborrhoeic dermatitis

100%

80%

60%

40%

20%

Study treatment Arm

Secukinumab 300 mg

Placebo/Secukinumab 300 mg

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~22760

0 / 7Eligibility criteria met

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.