TendinopathyPhase 3UnchAINNCT05569174
Study of Efficacy and Safety of AIN457/Secukinumab in Patients With Rotator Cuff Tendinopathy
A Phase 3 study testing Secukinumab in people with Tendinopathy, run by Novartis Pharmaceuticals at 19 sites in Germany.
Trial summary
The purpose of this study was to investigate the efficacy and safety of secukinumab subcutaneously (s.c.) compared to placebo in adult patients with moderate to severe rotator cuff tendinopathy and failure to conventional therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tendinopathy
- What is being tested?
- Secukinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 19 sitesGermany
- Study dates
- 2 Dec 2022to 18 Dec 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent had to be obtained prior to participation in the study.
- Males and non-pregnant, non-nursing females were between 18 and 65 years of age.
- Rotator cuff tendinopathy (unilateral) was present with a positive "Painful Arc Test" on examination.
- Symptoms had been present for at least 6 weeks but not more than 6 months at Baseline.
- Moderate to severe rotator cuff tendinopathy was demonstrated by all of the following criteria:
- WORC score was ≤ 40 at Baseline.
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- NRS pain score was ≥ 5 at Baseline and for at least 3 days of the 7 days prior to Baseline.
- Nocturnal pain occurred at least 4 out of the 7 days in the week prior to Baseline.
- Patients had failed at least 8 weeks of conventional therapy prior to Baseline: inadequate response to NSAIDs and/or paracetamol and physiotherapy; or intolerance to NSAIDs and/or paracetamol.
Who cannot join
- Greater than 50% partial thickness tear had been established by MRI or ultrasound during assessment in the Run-in phase.
- Patients were expected to require glucocorticoid treatment throughout the trial duration at Baseline (e.g., systemic, intramuscular, local injections in shoulder).
- Previous surgery, or plans for surgery, during the study period, in the affected shoulder.
- Rheumatologic and chronic inflammatory diseases, including but not limited to inflammatory bowel disease, polymyalgia rheumatica (PMR), PsA, axSpA and rheumatoid arthritis (RA), fibromyalgia or - severe pain disorder unrelated to the target shoulder.
- Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodies were positive at Screening.
- History of adhesive capsulitis/frozen shoulder or calcification in the tendon (in affected or contralateral shoulder) had been confirmed clinically or by medical imaging.
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- Symptomatic osteoarthritis of the shoulder (glenohumeral, acromioclavicular) in affected or contralateral shoulder had been confirmed by medical imaging.
- Patients had traumatic rupture that would have been considered eligible for surgery for repair of cuff tear.
- Neurological conditions including but not limited to cervical radiculopathy, which in the opinion of the investigator could have explained the patient's symptoms.
- Any intra-articular/subacromial glucocorticoid treatment had occurred within 12 weeks prior to Baseline or more than 2 injections for the current tendinopathy.
- Any oral, intramuscular or i.v. glucocorticoid treatment had occurred 12 weeks prior to Baseline or during the current tendinopathy, whichever was longer.
- Previous platelet rich plasma (PRP) injections or fluoroquinolone/quinolone antibiotics had occurred within 12 weeks prior to Baseline or during the current tendinopathy, whichever was longer.
- Neuromuscular or primary/secondary muscular deficiency had limited the ability to perform functional measurement (e.g., shoulder strength test).
- Previous hyaluronic injections had occurred within 12 weeks prior to Baseline or during the current tendinopathy, whichever was longer.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Germany19 sites
Novartis Investigative Site
Bad Doberan, 18209
Novartis Investigative Site
Berlin, 10787
Novartis Investigative Site
Berlin, 12627
Novartis Investigative Site
Cottbus, 03042
Novartis Investigative Site
Dresden, 01069
Novartis Investigative Site
Erlangen, 91054
Novartis Investigative Site
Frankfurt am Main, 60313
Novartis Investigative Site
Gladbeck, 45968
Novartis Investigative Site
Halle, Saxony-Anhalt, 06120
Novartis Investigative Site
Hamburg, 20095
Novartis Investigative Site
Hamburg, 20149
Novartis Investigative Site
Hamburg, 22415
Novartis Investigative Site
Hanover, Lower Saxony, 30159
Novartis Investigative Site
Heinsberg, 52525
Novartis Investigative Site
Herne, 44649
Novartis Investigative Site
Karlsruhe, Baden-Wurttemberg, 76133
Novartis Investigative Site
Mainz, 55131
Novartis Investigative Site
Munich, Bavaria, 80809
Novartis Investigative Site
Schönebeck, 39218
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, 24-week Study Investigating the Efficacy and Safety of Secukinumab Compared to Placebo in Adult Patients With Moderate to Severe Rotator Cuff Tendinopathy and Failure to Conventional Therapy
The purpose of this study was to investigate the efficacy and safety of secukinumab subcutaneously (s.c.) compared to placebo in adult patients with moderate to severe rotator cuff tendinopathy and failure to conventional therapy.
Read the detailed description
This was a randomized, double-blind, placebo-controlled, parallel-group, multicenter, Phase IIIb, 24-week study to investigate the superior efficacy of secukinumab and safety in participants with rotator cuff tendinopathy.
Secukinumab 300 mg s.c. was compared to placebo (both arms in combination with patient individualized conventional therapy) in relieving clinical symptoms at Week 24.
The study consisted of a screening period up to 6 weeks, a 2-week run-in period, a 12-week treatment period and a 12-week follow-up period. Treatment and follow-up periods were blinded. Participants who met the eligibility criteria at screening continued to the run-in period and were randomized. In the run-in period, participants performed 2 weeks of home-based standardized physiotherapy.
- Conditions
- Tendinopathy
- Being tested
- Secukinumab, Placebo
- Keywords
- shoulder, rotator cuff, IL-17A-Ab, AIN457X, Impingement syndrome
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecukinumabDrug
Also called AIN457
Secukinumab 300 mg s.c for 12 weeks in a pre-filled syringe (PFS)
PlaceboOther
Placebo to match secukinumab s.c. for 12 weeks in a PFS
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab | Experimental | Participants received 300 mg of secukinumab s.c. for 12 weeks Receives: Drug: Secukinumab |
| Placebo | Placebo comparator | Participants received placebo s.c. for 12 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Western Ontario Rotator Cuff (WORC) Patient Reported Outcome (PRO) Percentage Score at Week 24
The WORC Index consisted of 21 items divided into 5 Domains: Physical Symptoms (6 items), Sport/Recreation (4 items), Work Function (4 items), Lifestyle Function (4 items) and Emotional Function (3 items). Each of the 21 items in the WORC was rated using a visual analogue scale (VAS) ranging from 0 (no impact on quality of life) to 100 (worst possible impact). Thus, the total score ranged from 0 to 2100 points. The score was reported as a percentage of normal by subtracting the total score from 2100, dividing by 2100, and multiplying by 100. Total final WORC percentage scores ranged from 0%, the lowest functional status level, to 100%, the highest functional status level.
Change from baseline in the WORC percentage total score was assessed at Week 24. A positive change from baseline indicated an improvement.
Measured: Baseline, Week 24
Secondary outcomes (7)
Change From Baseline in the WORC Percentage Sub-scores at Week 24
The WORC Index consisted of 21 items divided into 5 Domains: Physical Symptoms (6 items), Sport/Recreation (4 items), Work Function (4 items), Lifestyle Function (4 items) and Emotional Function (3 items). Each of the 21 items in the WORC was rated using a VAS ranging from 0 (no impact on quality of life) to 100 (worst possible impact).
Each subdomain score was calculated as a percentage of normal function, ranging from 0% (worst condition) to 100% (best condition).
Change from baseline in the WORC Index percentage sub-domain score was assessed at Week 24. A positive change from baseline indicated an improvement
Measured: Baseline, Week 24
Change From Baseline in Participant's Global Assessment of Disease Activity Score at Week 24
The participant's global assessment of disease activity was performed using 100 mm VAS ranging from 0="no activity" to 100= "most active", after the question " Please indicate with a vertical mark ( | ) through the horizontal line the global activity of your disease in the last 24 hours".
Change from baseline in the participant's global assessment of disease activity score was assessed at Week 24. A negative change from baseline indicated improvement
Measured: Baseline, Week 24
Change From Baseline in Short Form 36 (SF-36v2) Score at Week 24
The SF-36 Health Survey was a validated questionnaire assessing health-related quality of life. Participants completed the survey throughout the study, reflecting their health status over the previous 4 weeks. It consisted of eight subscales that were scored individually; and two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Component summary scores (PCS and MCS) were derived from weighted combinations of the eight subscales. Each domain and component summary score ranged from 0 to 100, with higher scores indicating better quality of life.
Change from baseline to Week 24 in all subscale and summary scores was assessed, where a positive change indicated improvement.
Measured: Baseline, Week 24
Change From Baseline in Quick Disability of the Arm, Shoulder and Hand (DASH) Questionnaire Score at Week 24
The QuickDASH was an abbreviated form of the DASH. The QuickDASH Index was self-administered and used 11 items to measure physical function and symptoms in participants with any or multiple musculoskeletal disorders of the upper limb. It had a recall period of 1 week. Each item of the QuickDASH had five response options. The raw score was calculated as the sum of responses, converted to an average, and rescaled to a total score ranging from 0 (no disability) to 100 (most severe disability) Change from baseline to Week 24 was assessed. A negative change from baseline indicated improvement.
Measured: Baseline, Week 24
Change From Baseline in the Numeric Rating Scale (NRS) Pain Score at Week 24
The score for pain was assessed by using an 11-point NRS ranging from 0 "no pain at all" to 10 "worst possible pain", after the question "On a numeric scale of 0-10 where would you rate your pain at this time".
Change from baseline to Wek 24 was assessed. A negative change from baseline indicated improvement
Measured: Baseline, Week 24
Change From Baseline in EuroQol 5 Dimensions- 5 Levels (EQ-5D-5L) at Week 24- Total Score
The EQ-5D-5L was a standardized instrument used to evaluate patients' overall health-related quality of life (QoL). It consisted of two components: the descriptive system and the EQ visual analogue scale (EQ VAS).
The descriptive system assessed five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension was rated on five levels, from 1 (no problems) to 5 (extreme problems). These ratings were combined to generate a composite health index, which could be converted into a single summary health utility score using published value sets. Total scores ranged from 0 to 1, with lower scores indicating greater health impairment.
Changes in total scores from baseline to Week 24 were analyzed, with positive changes indicating improvement in health-related quality of life.
Measured: Baseline, Week 24
Change From Baseline in EuroQol 5 Dimensions- 5 Levels (EQ-5D-5L) at Week 24- EQ VAS
The EQ-5D-5L was a standardized instrument used to evaluate patients' overall health-related quality of life (QoL). It consisted of two components: the descriptive system and the EQ visual analogue scale (EQ VAS).
The EQ VAS captured the respondent's self-rated health on a vertical scale ranging from 0 (worst imaginable health) to 100 (best imaginable health).
Changes in EQ VAS scores from baseline to Week 24 were analyzed, with positive changes indicating improvement in health-related quality of life.
Measured: Baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start2 Dec 2022
- Primary completion18 Dec 2024
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569174
- Sponsor's protocol ID
- CAIN457FDE05
- Other IDs
- 2022-001516-26
- Acronym
- UnchAIN
- Status last verified
- Jan 2026
- First submitted
- 4 Oct 2022
- Last updated
- 23 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, 24-week Study Investigating the Efficacy and Safety of Secukinumab Compared to Placebo in Adult Patients With Moderate to Severe Rotator Cuff Tendinopathy and Failure to Conventional Therapy
- ClinicalTrials.gov ID
- NCT05569174
- Acronym / sponsor ID
- UnchAIN / CAIN457FDE05
- Conditions
- Tendinopathy
- Keywords
- shoulder, rotator cuff, IL-17A-Ab, AIN457X, Impingement syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 6 Oct 2022 (actual)
- Results
- Posted 2 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to investigate the efficacy and safety of secukinumab subcutaneously (s.c.) compared to placebo in adult patients with moderate to severe rotator cuff tendinopathy and failure to conventional therapy.
Detailed description
This was a randomized, double-blind, placebo-controlled, parallel-group, multicenter, Phase IIIb, 24-week study to investigate the superior efficacy of secukinumab and safety in participants with rotator cuff tendinopathy.
Secukinumab 300 mg s.c. was compared to placebo (both arms in combination with patient individualized conventional therapy) in relieving clinical symptoms at Week 24.
The study consisted of a screening period up to 6 weeks, a 2-week run-in period, a 12-week treatment period and a 12-week follow-up period. Treatment and follow-up periods were blinded. Participants who met the eligibility criteria at screening continued to the run-in period and were randomized. In the run-in period, participants performed 2 weeks of home-based standardized physiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Secukinumab | Experimental | Drug: SecukinumabParticipants received 300 mg of secukinumab s.c. for 12 weeks |
| Placebo | Placebo comparator | Other: PlaceboParticipants received placebo s.c. for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed informed consent had to be obtained prior to participation in the study.
- Males and non-pregnant, non-nursing females were between 18 and 65 years of age.
- Rotator cuff tendinopathy (unilateral) was present with a positive "Painful Arc Test" on examination.
- Symptoms had been present for at least 6 weeks but not more than 6 months at Baseline.
- Moderate to severe rotator cuff tendinopathy was demonstrated by all of the following criteria:
Key exclusion criteria (14 listed)
- Greater than 50% partial thickness tear had been established by MRI or ultrasound during assessment in the Run-in phase.
- Patients were expected to require glucocorticoid treatment throughout the trial duration at Baseline (e.g., systemic, intramuscular, local injections in shoulder).
- Previous surgery, or plans for surgery, during the study period, in the affected shoulder.
- Rheumatologic and chronic inflammatory diseases, including but not limited to inflammatory bowel disease, polymyalgia rheumatica (PMR), PsA, axSpA and rheumatoid arthritis (RA), fibromyalgia or - severe pain disorder unrelated to the target shoulder.
- Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodies were positive at Screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SecukinumabAlso: AIN457Secukinumab 300 mg s.c for 12 weeks in a pre-filled syringe (PFS) | Drug | Secukinumab |
| PlaceboPlacebo to match secukinumab s.c. for 12 weeks in a PFS | Other | Placebo |
Primary outcome
Change From Baseline in the Western Ontario Rotator Cuff (WORC) Patient Reported Outcome (PRO) Percentage Score at Week 24
Time frame: Baseline, Week 24
The WORC Index consisted of 21 items divided into 5 Domains: Physical Symptoms (6 items), Sport/Recreation (4 items), Work Function (4 items), Lifestyle Function (4 items) and Emotional Function (3 items). Each of the 21 items in the WORC was rated using a visual analogue scale (VAS) ranging from 0 (no impact on quality of life) to 100 (worst possible impact). Thus, the total score ranged from 0 to 2100 points. The score was reported as a percentage of normal by subtracting the total score from 2100, dividing by 2100, and multiplying by 100. Total final WORC percentage scores ranged from 0%, the lowest functional status level, to 100%, the highest functional status level. Change from baseline in the WORC percentage total score was assessed at Week 24. A positive change from baseline indicated an improvement.
7 secondary outcomes
Change From Baseline in the WORC Percentage Sub-scores at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Participant's Global Assessment of Disease Activity Score at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Short Form 36 (SF-36v2) Score at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Quick Disability of the Arm, Shoulder and Hand (DASH) Questionnaire Score at Week 24
Time frame: Baseline, Week 24
Change From Baseline in the Numeric Rating Scale (NRS) Pain Score at Week 24
Time frame: Baseline, Week 24
Change From Baseline in EuroQol 5 Dimensions- 5 Levels (EQ-5D-5L) at Week 24- Total Score
Time frame: Baseline, Week 24
Change From Baseline in EuroQol 5 Dimensions- 5 Levels (EQ-5D-5L) at Week 24- EQ VAS
Time frame: Baseline, Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Secukinumab in people with Tendinopathy, run by Novartis Pharmaceuticals at 19 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Western Ontario Rotator Cuff (WORC) Patient Reported Outcome (PRO) Percentage Score at Week 24 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.