## [Clinical Trial Rotator cuff tendinopathy](/us-en/clinicaltrials/immunology/RCT/NCT05722522-NCT05758415 "Clinical Trial Rotator cuff tendinopathy") We're conducting a clinical trial to see if an investigational drug may help reduce pain and improve physical shoulder symptoms in people with rotator cuff tendinopathy Rotator cuff tendinopathy, or ‘RCT', can have a profound impact on daily life. Individuals are often expected to just live with the pain, but symptoms can have a serious effect on sleep and ability to do day-to-day tasks such as housework or even eating a meal.1 Current standard of care treatments, including nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or aspirin, only address the symptoms rather than treating the condition. That’s why we’re running a clinical trial to see if an investigational drug can help improve physical shoulder function and reduce pain in people with RCT. [See if you're eligible](https://antidote.me/prescreener/s/en-US/rotator_cuff_tendinopathy-207/questions/1 "See if you're eligible") ## About RCT - RCT is a common condition marked by activity-related shoulder pain and weakness, as well as impairments in function and range of motion.2 - RCT often occurs due to wear and tear, as well as overuse over time. Common causes can be sports with repetitive overhead movement (such as swimming, golf or volleyball), or certain professions (such as painters, warehouse workers, hairdressers and carpenters). - The main symptom is pain in the shoulder and outer upper arm, worsening when raising hands above the head. This pain can cause difficulty with performing daily activities and sleeping. ## What will this trial involve? This is a **phase 3 clinical trial** and will last for approximately 32 weeks, as outlined below: Screening period (approximately 8 weeks) We’ll carry out some tests to see if potential participants are eligible for the trial. Treatment period (approximately 16 weeks) Participants will be randomly assigned to receive either: - The investigational drug (1 in 2 chance) Or - A placebo (1 in 2 chance) *One subcutaneous (under the skin) injection will be administered every week for the first month, then every 4 weeks.\** Follow-up period (approximately 8 weeks) We’ll continue to monitor participants’ health and condition. \*Please note that the trial drug assigned to you can be administered at home on two of the first four weeks, if this is more convenient. That said, participants can also receive their injection at the study site if preferred; if this is the case, please speak to a member of the study team and they can arrange that for you. [See if you're eligible](https://antidote.me/prescreener/s/en-US/rotator_cuff_tendinopathy-207/questions/1 "See if you're eligible") ## How is the investigational drug thought to work? - In the early stages of tendinopathy, levels of a protein called IL-17A increase in the affected tissue. - IL-17A has a role in the immune system in fighting off infection, but it also plays a role in inflammation that can contribute to the development of RCT. - The investigational drug is an IL-17A inhibitor, which means it aims to reduce levels of IL-17A in the body. - We’re assessing the investigational drug’s impact on shoulder symptoms for people with rotator cuff tendinopathy. ## Who can take part? ![Trial eligibility Yes checkbox in blue square icon](/us-en/sites/novartis_us/files/styles/crop_freeform/public/2022-08/check-icon.jpg.webp?itok=ep3Eoqnr "Trial eligibility Yes checkbox in blue square icon") **To take part in this clinical trial, in addition to other criteria, potential participants must:** - Be between 18 and 65 years old - Have experienced symptoms of RCT in the past 6 months - Undergo a magnetic resonance imaging (MRI) scan to confirm RCT ![Trial Eligibility No cross mark in blue square icon](/us-en/sites/novartis_us/files/styles/crop_freeform/public/2022-08/cross-icon.jpg.webp?itok=1oLY8yo_ "Trial Eligibility No cross mark in blue square icon") **potential participants must not:** - Be pregnant or breast feeding (or trying to become pregnant) - Have had surgery on the affected shoulder - Have been diagnosed with any of the following conditions: fibromyalgia, gout, psoriasis, rheumatoid arthritis, or tuberculosis For full eligibility criteria of each trial, please visit: - **Trial 1:** Study of Efficacy and Safety of Secukinumab in Participants With Moderate-severe Rotator Cuff Tendinopathy - Full Text View - [ClinicalTrials.gov](https://classic.clinicaltrials.gov/ct2/show/NCT05722522?term=secukinumab&cond=cuff&draw=2&rank=1) - **Trial 2:** Study of Efficacy and Safety of Secukinumab in Participants With Moderate-severe Rotator Cuff Tendinopathy - Full Text View - [ClinicalTrials.gov](https://classic.clinicaltrials.gov/ct2/show/NCT05758415?term=secukinumab&cond=cuff&draw=2&rank=2) Participation in this clinical trial is completely voluntary. [See if you're eligible](https://antidote.me/prescreener/s/en-US/rotator_cuff_tendinopathy-207/questions/1 "See if you're eligible") ## How will each participant’s health be monitored? During this trial, participants will visit a clinic **approximately 10 to 12 times**. This is so that we can monitor their general health through health checks, such as: ![Stethoscope Icon](/us-en/sites/novartis_us/files/styles/cards_1_3/public/2022-08/stethoscope-icon.jpg.webp?itok=cyoNg6Sz "Stethoscope Icon") ### Physical examinations ![Blood tests, blue syringe icon](/us-en/sites/novartis_us/files/styles/cards_1_3/public/2022-08/syringe-icon.jpg.webp?itok=hR2cSGsi "Blood tests, blue syringe icon") ### Blood tests ![Skin prick testing, blue microscope icon](/us-en/sites/novartis_us/files/styles/cards_1_3/public/2022-08/microscope-icon.jpg.webp?itok=SBFRo44p "Skin prick testing, blue microscope icon") ### RCT assessments ![Questionnaires, blue writing on sheet icon](/us-en/sites/novartis_us/files/styles/cards_1_3/public/2022-08/paper-icon.jpg.webp?itok=psbxkulx "Questionnaires, blue writing on sheet icon") ### Questionnaires ![Vital signs, blue heart icon](/us-en/sites/novartis_us/files/styles/cards_1_3/public/2022-08/heart-icon.jpg.webp?itok=djqXaHSN "Vital signs, blue heart icon") ### Vital signs [See if you're eligible](https://antidote.me/prescreener/s/en-US/rotator_cuff_tendinopathy-207/questions/1 "See if you're eligible") ## About Clinical Trials ![Smiling female doctor reassuring a smiling male clinical trial participant by patting him on the shoulder in a supportive manner.](/us-en/sites/novartis_us/files/styles/cta_image/public/2022-08/smiling-female-doctor-smiling-patient.jpg.webp?itok=y0jAiS6Q "Smiling female doctor reassuring a smiling male clinical trial participant by patting him on the shoulder in a supportive manner.") ## What is a clinical trial? Every year, hundreds of thousands of people take part in clinical trials (also known as clinical studies). These are carefully controlled scientific investigations that help us improve medicine all around the world. They help us discover: - Alternative ways to diagnose conditions - Alternative ways to treat conditions - Alternative ways to track the progress of conditions Clinical trials must be approved by regulatory boards before they can begin. These boards work to protect the safety and rights of trial participants. They do this by reviewing and approving the trial’s protocol – a plan that explains the need for the trials, what participants will need to do and how their health will be monitored throughout. ### Different types of clinical trials Clinical trials help us answer scientific questions, but different types of trials help us do this in different ways. For example: ![Woman and clinical trial doctor reviewing different types of clinical trial notes](/us-en/sites/novartis_us/files/styles/cta_image/public/2022-08/woman-and-clinical-trial-doctor.jpg.webp?itok=kOXqCZsf "Woman and clinical trial doctor reviewing different types of clinical trial notes") ## Interventional trials Participants are asked to change their care somehow. For example, they may be asked to take an investigational drug or change their diet. ![Clinical trial nurse and clinical trial participant reviewing body weight on weighing scales](/us-en/sites/novartis_us/files/styles/cta_image/public/2022-08/clinical-trial-nurse-and-participant.jpg.webp?itok=t5rcAO-b "Clinical trial nurse and clinical trial participant reviewing body weight on weighing scales") ## Observational trials Participants are asked to continue their usual healthcare regimen while healthcare professionals monitor their condition. For example, the level of a certain substance (e.g. an antibody) in the blood could be monitored. ## Different phases of clinical trials An investigational drug must pass through several stages of clinical trials before it can be submitted for approval for general use by the public. Each stage helps us answer different questions. Only once an investigational therapy has been shown to be safe in one phase may it progress to the next. Phase 1 Investigators study the effects of an investigational drug in about 20 - 80 people. This phase is important for ensuring that an investigational drug is safe and helps us learn which doses may have a therapeutic effect. Phase 2 These trials are conducted in a slightly larger group of about 100 - 300 people. The investigational drug may be compared with a **placebo** (a ‘dummy drug’) to help us learn whether it is an effective treatment and learn more about any potential side effects. Phase 3 These usually involve up to 3,000 people to help us understand more about the safety and efficacy of an investigational drug, as well as how well it compares to existing treatments for a particular condition. ### Medication approved for general use Phase 4 These trials help us learn how the treatment affects people in the long-term. They only take place once a drug has been approved for general use. ## Frequently Asked Questions We’ve compiled answers to some of the most common questions about clinical trials, as well as any specific questions related to this particular trial. If you have any other questions, please contact the trial team, who will be more than happy to assist you. ## About our RCT trial What are the benefits and potential risks of taking part? Benefits to taking part in this clinical trial include frequent health assessments. Risks to taking part in this clinical trial include: - The investigational drug may have unknown side effects - The investigational drug may not work for you Your RCT may stay the same or get worse. But even though taking part may not benefit you directly, your participation may help us learn new things that may help treat people with RCT in the future. How will my data be protected? Your clinical trial data and samples will be labeled with a participant identification, or ID, number that is unique to you and not related to or derived from information that identifies you. This means that people who have access to the clinical trial data will not be able to identify you. What happens if I can’t make a clinic visit or miss one? It’s really important that you stick to the visit schedule so that we can closely monitor your health and give you your trial treatment. However, we do understand that plans can suddenly change. Therefore, if you can’t make a visit, or you miss one, please contact the trial team as soon as possible. They can then reschedule your appointment. [Find out if you can take part](https://antidote.me/prescreener/s/en-US/rotator_cuff_tendinopathy-207/questions/1 "Find out if you can take part") ## About Clinical Trials What is a placebo and why is it used? A placebo looks just like the investigational drug and is given in the same way. However, it contains no active ingredients. Placebos are used to be sure that any treatment effects seen are due to the investigational drug and not some other factor, such as increased visits with the trial doctors. What will happen if I change my mind part-way through the trial and decide to leave? Participation in clinical trials is voluntary. This means that you are under no obligation to take part and you are free to leave at any time without affecting your usual healthcare. However, we would encourage all potential participants to stay in a trial for its duration, if possible. Do I need medical insurance to take part? No. You do not need medical insurance to take part in clinical trials. Are clinical trials safe? Every clinical trial must be approved by regulatory boards (such as the US Food and Drug Administration) before it can begin. It is the job of these boards to protect the safety and rights of a trial’s participants. They do this by reviewing the trial’s protocol. A protocol is a plan that explains the need for the trial, what participants will need to do, and how their health will be monitored. Before a person can be enrolled into a clinical trial, they must meet eligibility criteria specific to that trial. Will I have to pay for anything? There is no cost to participate in a trial and insurance is also not required. Study-related medications and tests are provided at no cost. Many trials may pay for travel and accommodation-related expenses too. How many times will I have to visit the trial site? This will depend on the trial. You will be provided with a detailed visit schedule before you enroll. Will I need to take time off work to take part in the trial? You may well have to take time off work to make appointments at the trial’s site. Before you enroll, you will be given a detailed visit schedule so you can consider this commitment before you decide to volunteer. Why won’t I know which group I’ll be in? Many clinical trials are ‘randomized’ and ‘double-blind’. Randomized means you will be allocated to a treatment group by chance, like the flip of a coin. Double-blind means that neither the participant nor the trial team will know which group the participant is in until after the trial is complete. This is to ensure that any effects seen are due to the investigational drug alone. References: 1. [https://www.physiotherapyjournal.com/article/S0031-9406(13)00059-X/full…](https://www.physiotherapyjournal.com/article/S0031-9406(13)00059-X/fulltext#secsect0060) 2. [https://journals.lww.com/jaaos/Fulltext/2020/03010/Management\_of\_Rotato…](https://journals.lww.com/jaaos/Fulltext/2020/03010/Management_of_Rotator_Cuff_Injuries.4.aspx)