Study on the Effectiveness and Safety of Secukinumab for Adults with Moderate to Severe Rotator Cuff Tendinopathy

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What is this study about?

This clinical trial is focused on studying the effects of a medication called secukinumab on individuals with moderate to severe rotator cuff tendinopathy. Rotator cuff tendinopathy is a condition that affects the shoulder, causing pain and difficulty in movement. The study aims to determine if secukinumab, given as an injection under the skin, is more effective than a placebo in improving shoulder symptoms over a period of 16 weeks.

Participants in the study will receive either secukinumab or a placebo. Secukinumab is a solution for injection that is administered using a pre-filled syringe. The study will last for 24 weeks, during which participants will be monitored for changes in their shoulder symptoms. The main goal is to see if secukinumab can significantly improve physical symptoms compared to the placebo. The study will also assess the safety and tolerability of secukinumab by monitoring any side effects or changes in health indicators.

Throughout the study, participants will have regular check-ups to track their progress and any changes in their condition. The study will also involve the use of MRI scans to confirm the presence of tendinopathy in the shoulder. The results will help determine the effectiveness of secukinumab in treating moderate to severe rotator cuff tendinopathy and provide valuable information on its safety for patients.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, such as having moderate to severe rotator cuff tendinopathy for a duration between 6 weeks and 6 months.

Participants must have experienced shoulder pain at night on at least 3 out of 7 nights before the baseline visit or have a positive painful arc test.

An MRI is conducted to confirm the presence of tendinopathy without significant tears.

2 baseline assessment

A baseline assessment is conducted to evaluate the initial condition using the Western Ontario Rotator Cuff Index (WORC) and other measures.

Participants are required to maintain a stable regimen of NSAIDs and physiotherapy from this point until the end of the study.

3 treatment phase

Participants receive either secukinumab or a placebo. Secukinumab is administered as a 300 mg subcutaneous injection.

The treatment is given at specified intervals, with serum concentrations measured on Day 1 and Weeks 4 and 16.

4 mid-study evaluation

At Week 16, the primary endpoint is assessed by measuring changes in the WORC Physical Symptom Domain score.

Secondary endpoints include improvements in other scores and the safety and tolerability of the treatment.

5 end of study evaluation

At Week 24, further assessments are conducted to evaluate long-term improvements in shoulder symptoms.

The study concludes with a final evaluation of safety, including any adverse effects and changes in laboratory parameters.

Who Can Join the Study?

Have moderate to severe rotator cuff tendinopathy in one shoulder, with symptoms lasting between 6 weeks and 6 months.
Experience nighttime shoulder pain on at least 3 out of 7 nights in the week before the study starts, or have a positive painful arc test during a physical exam. A painful arc test is a way to check for shoulder pain when lifting the arm.
Have a WORC percentage score of 40 or less at the screening and start of the study. WORC is a questionnaire that measures shoulder problems.
Have an average pain score of 5 or more over the past 7 days before the study starts, based on a scale where you rate your pain each day.
Have tried standard treatments like NSAIDs (non-steroidal anti-inflammatory drugs) and physiotherapy for 8 weeks, but still have symptoms. NSAIDs are common pain relievers.
Agree to keep the same dose of NSAIDs and continue physiotherapy from the start of the study until the end, unless you can’t tolerate them or they are not recommended for you. You can reduce the NSAID dose but not increase it.
Have tendinopathy in the affected shoulder confirmed by an MRI (Magnetic Resonance Imaging) scan, with no tear or only a partial tear of the tendon. A partial tear means the tendon is damaged but not completely torn, with a maximum of 50% thickness affected and a length of up to 10 mm.
Be within the age range specified for the study.
Both male and female participants are eligible.
Participants from vulnerable populations can also join the study.

Who Cannot Join the Study?

Participants with any other shoulder condition that could interfere with the study results.
Individuals who have had recent shoulder surgery or plan to have shoulder surgery during the study period.
People with a history of allergic reactions to the study medication or similar medications.
Participants who are currently using other treatments that could affect the study outcomes.
Individuals with severe health conditions that could make participation unsafe.
Pregnant or breastfeeding women.
Participants who are unable to follow the study procedures or attend study visits.
Individuals with a history of drug or alcohol abuse that could interfere with the study.
People who have participated in another clinical trial recently.
Participants with certain infections or immune system disorders.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Kat Attica General Hospital	Kifissia	Greece
InterHem Poradnie Specjalistyczne	Bialystok	Poland
Indywidualna Praktyka Lekarska Lekarz Paweł Bazela	Elblag	Poland

Other Sites

Site Name	City	Country
Revita Kft.	Budapest	Hungary
Sanos A/S	Gandrup	Denmark
Athens Medical Center S.A.	Athens	Greece
Irmed Klimkiewicz Rudziewicz-Kowalska sp. j.	Piotrkow Trybunalski	Poland
Mypvelxvc Ijaikqwajh Crzazbak Snguamse Skw z opxz	Warsaw	Poland
Gylvike Uoslpirrhg Hdvsdipf On Lzbtfgi	Larissa	Greece
Ulctzjridp Ob Dmdojyoy	Debrecen	Hungary
Hveriblt Uhyngmddxqwgn dw A Czagqk	A Coruna Galicia	Spain
Hwxwznba Ukyrkcwehmuhv Fvwwstgwx Jugdtmj Duvf	Madrid	Spain
Uxmbrsrttmhrqfdzw Pvktydednht Dpubl Mzeimv	Ancona	Italy
Awwghyr Shtinzplt Ugdgtfzhfnsbe Fbswqp Cswggnhx	Udine	Italy
Gkegxq Nbbiwyijbk Tbbnzfmjtmiuj Gakvto Prpavdnwuvwk	Thessaloniki	Greece
Pwcr Tcbhx Hivudkvn Ubzurhahexop	Sabadell	Spain
Cmgiuye Gazrf Sqazdbfk	Santiago De Compostela	Spain
Eey Nssvtesodyuw Sdp z oolf	Warsaw	Poland
Ufspwcsrcc Ov Lcnbdqercnylst	L'aquila	Italy
Cadpzjq Mjfbrfhr Sjwjuv Fkimum	Cracow	Poland
Dly Kddy	Szekesfehervar	Hungary
Auhhxgm Obfqixqllkq Usfhoogpoxswv Svjces	Siena	Italy
Hxcuiuji Uzbrashffodwf Quxotrmfgnt Mevpca	Pozuelo De Alarcon	Spain
Atxqufy Onzbujhxgff Scit Apxd E Sjl Swztfaleyn Di Chnacoo	Caserta	Italy
Acpykrx Soquujyea Lsazix 2 Lzqwfttd Vkbbs Cjhluv	Chieti	Italy
Iwkspxct Oprdpgfnlr Rqomcqy	Bologna	Italy
Fbdtmamt Db Ropvkwf Czpiaj Bupzdlunhjbtytjcec Dsukboieztjrtjil Blocexapwcz Aopclb Pf I Sghqmd	Barcelona	Spain
Ojimchzf Gpujsgmw Sqjsdj	Milan	Italy
Defkqr Mteazy Kzpmxgkp sprll	Swidnica	Poland
Aelsaej Srlnjsuujrnkup 3	Genoa	Italy
Hpkjjale Hl Ruvaczhs Hi Lt Erleinskm	Santiago De Compostela	Spain

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	15.09.2023
Greece	Not recruiting	15.09.2023
Hungary	Not recruiting	15.09.2023
Italy	Not recruiting	15.09.2023
Poland	Not recruiting	15.09.2023
Spain	Not recruiting	15.09.2023

Trial locations

Investigated Drugs:

Secukinumab is a medication used in this clinical trial to treat patients with active rotator cuff tendinopathy. It is designed to help reduce inflammation and improve physical shoulder symptoms in individuals with moderate to severe conditions. The trial aims to demonstrate that secukinumab is more effective than a placebo in improving these symptoms over a period of 16 weeks.

Rotator Cuff Tendinopathy – This condition involves inflammation or irritation of the tendons in the shoulder’s rotator cuff. It typically results from repetitive overhead activities or acute injury, leading to pain and weakness in the shoulder. As the condition progresses, individuals may experience increased discomfort during shoulder movements, especially when lifting the arm. Over time, the tendons may become more damaged, potentially leading to partial or complete tears. The severity of symptoms can vary, with some people experiencing mild discomfort and others facing significant pain and limited shoulder function. Regular activities such as reaching, lifting, or sleeping on the affected side may become challenging.

Trial ID:

2022-502080-38-00

Protocol code:

CAIN457O12302

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Secukinumab for Adults with Moderate to Severe Rotator Cuff Tendinopathy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?