Study of Efficacy and Safety of AIN457/Secukinumab in Patients With Rotator Cuff Tendinopathy (UnchAIN)
Primary Purpose
Tendinopathy
Status
Recruiting
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
secukinumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Tendinopathy focused on measuring shoulder, rotator cuff, IL-17A-Ab, AIN457X, Impingement syndrome
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent must be obtained prior to participation in the study.
- Males and non-pregnant, non-nursing females between 18 and 65 years of age
- Rotator cuff tendinopathy (unilateral) with positive "Painful Arc Test" on examination
- Symptoms present for at least 6 weeks but not more than 6 months at Baseline
Moderate to severe rotator cuff tendinopathy demonstrated by all of the following criteria:
- WORC score β€ 40 at Baseline
- NRS pain score β₯ 5 at Baseline and at least 3 days of the past 7 days prior to Baseline
- Nocturnal pain at least 4 out of past 7 days in the week prior to Baseline
- Failure to 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
Exclusion Criteria:
- Greater than 50% partial thickness tear as established by MRI or ultrasound during assessment in Run-in phase
- Patients who are 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 positive at Screening
- History of adhesive capsulitis/frozen shoulder or calcification in the tendon (in affected or contralateral shoulder) confirmed clinically or by medical imaging
- Symptomatic osteoarthritis of the shoulder (glenohumeral, acromioclavicular) in affected or contralateral shoulder confirmed by medical imaging
- Patients with traumatic rupture that would be 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 may explain the patient's symptoms
- Any intra-articular/subacromial glucocorticoid treatment within 12 weeks prior to Baseline or more than 2 injections for the current tendinopathy.
- Any oral, intramuscular or i.v. glucocorticoid treatment 12 weeks prior to Baseline or during the current tendinopathy, whichever takes longer
- Previous platelet rich plasma (PRP) injections or fluoroquinolone/quinolone antibiotics within 12 weeks prior to Baseline or during the current tendinopathy, whichever takes longer
- Neuromuscular or primary/secondary muscular deficiency which limits the ability to perform functional measurement (e.g., shoulder strength test)
- Previous hyaluronic injections within 12 weeks prior to Baseline or during the current tendinopathy, whichever takes longer
Sites / Locations
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
secukinumab
Placebo
Arm Description
AIN457 300 mg subcutaneously (s.c.) for 12 weeks
Placebo subcutaneously for 12 weeks
Outcomes
Primary Outcome Measures
The Western Ontario Rotator Cuff (WORC) Patient Reported Outcome (PRO) Score at Week 14 in All Patients
WORC PRO score at week 24. The WORC Index consists 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). The total scores and sub scores used were the percentages of the normal scores with 0 being worst and 100 being best.
Secondary Outcome Measures
The Western Ontario Rotator Cuff (WORC) Patient Reported Outcome (PRO) Score in each subdomain
WORC PRO score at week 24. The WORC Index consists 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). The total scores and sub scores used were the percentages of the normal scores with 0 being worst and 100 being best.
Patient Global Assessment (PaGA) Score
The patient's global assessment of disease activity is performed using a 100 mm Visual Analog Scale (VAS) ranging from "no activity" to "most active" in the last 24 hours.
The scale range for PGA score is 0-100, 0 being the best possible outcome (no disease activity) and 100 being the worst possible outcome (maximal disease activity).
Disease activity and quality of life for the Short Form 36 (SF-36v2) score
To assess the effect of secukinumab compared to placebo measured by disease activity and quality of life measures at Week 52 for Short form 36v2
Score range is from 0 to 100. Higher scores indicate better health status.
Disability of Arm, Shoulder and Hand Questionnaire Score (QuickDASH) Over Time
Patient Reported Outcome: Disability of Arm, Shoulder and Hand (QuickDASH) This questionnaire asks about symptoms as well participant's ability to do certain activities - ranging from 1 (No difficulty) to 5 (Unable).
The scale range for QuickDASH total score is 0-100, 0 being the best possible outcome and 100 being the worst possible outcome
Pain Score Using a Numeric Rating Scale (NRS)
Pain intensity is assessed by a Numeric Rating Scale (NRS) which is measured in a scale of 11 points.
The scale range for pain score is 0-10, 0 being the best possible outcome (no pain) and 10 being the worst possible outcome (worst pain).
EQ-5D-5L Index Score
Patient Reported Outcome: Statistical analysis results of EQ-5D-5L Index score, which contains 5 items to assess Health Status (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression). Overall scores range from 0 to 1 with lower scores representing a higher level of dysfunction.
Number of participants with Adverse Events
Safety and tolerability assessments over time: incidence and severity of AEs and SAEs; routine safety laboratory parameters
To evaluate safety and tolerability of secukinumab 300 mg s.c. in participants with moderate to severe rotator cuff tendinopathy.
Full Information
NCT ID
NCT05569174
First Posted
October 4, 2022
Last Updated
October 23, 2023
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT05569174
Brief Title
Study of Efficacy and Safety of AIN457/Secukinumab in Patients With Rotator Cuff Tendinopathy
Acronym
UnchAIN
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2022 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the efficacy and safety of AIN457 (secukinumab s.c.) compared to placebo in adult patients with moderate to severe rotator cuff tendinopathy and failure to conventional therapy.
The study duration will be 24 weeks.
The treatment duration will 12 weeks with 12 weeks follow-up.
The visit frequency will be weekly until visit 7 and 4-weekly until end of treatment and 4 follow-up visits.
Detailed Description
This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, Phase IIIb, 24-week study to investigate the superior efficacy of AIN457/secukinumab and safety in participants with rotator cuff tendinopathy.
Secukinumab 300 mg s.c. will be compared to placebo (both arms in combination with patient individualized conventional therapy) in relieving clinical symptoms at week 24. Approximately 430 participants (215 per treatment group) will be included with a diagnosis of moderate to severe rotator cuff tendinopathy with no tear or partial tear, who are experiencing active disease for at least 6 weeks and no more than 6 months at Baseline and who have failed to respond to conventional therapy.
The study consists 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 period will be blinded. The Screening period will assess eligibility. Participants who meet the eligibility criteria at Screening will continue to Run-in period and will be randomized. In the Run-in period participants should perform 2 weeks of home-based standardized physiotherapy. The Run-in period is initiated by a telephone visit 14 days prior to Randomization. The study comprises a total of 13 visits.
Eligible participants will be randomized 1:1 to either receive secukinumab 300 mg s.c. or placebo s.c. at Baseline, week 1, 2, 3, 4, 8 and 12 (7 injections in total).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy
Keywords
shoulder, rotator cuff, IL-17A-Ab, AIN457X, Impingement syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
430 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
secukinumab
Arm Type
Experimental
Arm Description
AIN457 300 mg subcutaneously (s.c.) for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo subcutaneously for 12 weeks
Intervention Type
Drug
Intervention Name(s)
secukinumab
Other Intervention Name(s)
AIN457
Intervention Description
AIN457 300 mg subcutaneously for 12 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo to match AIN457 subcutaneously for 12 weeks
Primary Outcome Measure Information:
Title
The Western Ontario Rotator Cuff (WORC) Patient Reported Outcome (PRO) Score at Week 14 in All Patients
Description
WORC PRO score at week 24. The WORC Index consists 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). The total scores and sub scores used were the percentages of the normal scores with 0 being worst and 100 being best.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
The Western Ontario Rotator Cuff (WORC) Patient Reported Outcome (PRO) Score in each subdomain
Description
WORC PRO score at week 24. The WORC Index consists 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). The total scores and sub scores used were the percentages of the normal scores with 0 being worst and 100 being best.
Time Frame
Week 24
Title
Patient Global Assessment (PaGA) Score
Description
The patient's global assessment of disease activity is performed using a 100 mm Visual Analog Scale (VAS) ranging from "no activity" to "most active" in the last 24 hours.
The scale range for PGA score is 0-100, 0 being the best possible outcome (no disease activity) and 100 being the worst possible outcome (maximal disease activity).
Time Frame
Week 24
Title
Disease activity and quality of life for the Short Form 36 (SF-36v2) score
Description
To assess the effect of secukinumab compared to placebo measured by disease activity and quality of life measures at Week 52 for Short form 36v2
Score range is from 0 to 100. Higher scores indicate better health status.
Time Frame
Week 24
Title
Disability of Arm, Shoulder and Hand Questionnaire Score (QuickDASH) Over Time
Description
Patient Reported Outcome: Disability of Arm, Shoulder and Hand (QuickDASH) This questionnaire asks about symptoms as well participant's ability to do certain activities - ranging from 1 (No difficulty) to 5 (Unable).
The scale range for QuickDASH total score is 0-100, 0 being the best possible outcome and 100 being the worst possible outcome
Time Frame
Week 24
Title
Pain Score Using a Numeric Rating Scale (NRS)
Description
Pain intensity is assessed by a Numeric Rating Scale (NRS) which is measured in a scale of 11 points.
The scale range for pain score is 0-10, 0 being the best possible outcome (no pain) and 10 being the worst possible outcome (worst pain).
Time Frame
Week 24
Title
EQ-5D-5L Index Score
Description
Patient Reported Outcome: Statistical analysis results of EQ-5D-5L Index score, which contains 5 items to assess Health Status (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression). Overall scores range from 0 to 1 with lower scores representing a higher level of dysfunction.
Time Frame
Week 24
Title
Number of participants with Adverse Events
Description
Safety and tolerability assessments over time: incidence and severity of AEs and SAEs; routine safety laboratory parameters
To evaluate safety and tolerability of secukinumab 300 mg s.c. in participants with moderate to severe rotator cuff tendinopathy.
Time Frame
Baseline up to Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Signed informed consent must be obtained prior to participation in the study.
Males and non-pregnant, non-nursing females between 18 and 65 years of age
Rotator cuff tendinopathy (unilateral) with positive "Painful Arc Test" on examination
Symptoms present for at least 6 weeks but not more than 6 months at Baseline
Moderate to severe rotator cuff tendinopathy demonstrated by all of the following criteria:
WORC score β€ 40 at Baseline
NRS pain score β₯ 5 at Baseline and at least 3 days of the past 7 days prior to Baseline
Nocturnal pain at least 4 out of past 7 days in the week prior to Baseline
Failure to 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
Exclusion Criteria:
Greater than 50% partial thickness tear as established by MRI or ultrasound during assessment in Run-in phase
Patients who are 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 positive at Screening
History of adhesive capsulitis/frozen shoulder or calcification in the tendon (in affected or contralateral shoulder) confirmed clinically or by medical imaging
Symptomatic osteoarthritis of the shoulder (glenohumeral, acromioclavicular) in affected or contralateral shoulder confirmed by medical imaging
Patients with traumatic rupture that would be 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 may explain the patient's symptoms
Any intra-articular/subacromial glucocorticoid treatment within 12 weeks prior to Baseline or more than 2 injections for the current tendinopathy.
Any oral, intramuscular or i.v. glucocorticoid treatment 12 weeks prior to Baseline or during the current tendinopathy, whichever takes longer
Previous platelet rich plasma (PRP) injections or fluoroquinolone/quinolone antibiotics within 12 weeks prior to Baseline or during the current tendinopathy, whichever takes longer
Neuromuscular or primary/secondary muscular deficiency which limits the ability to perform functional measurement (e.g., shoulder strength test)
Previous hyaluronic injections within 12 weeks prior to Baseline or during the current tendinopathy, whichever takes longer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Muenchen
State/Province
Bavaria
ZIP/Postal Code
80809
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bad Doberan
State/Province
Mecklenburg Vorpommern
ZIP/Postal Code
18209
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Leipzig
State/Province
Saxonia
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Cottbus
ZIP/Postal Code
03042
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
EichstΓ€tt
ZIP/Postal Code
85072
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Gommern
ZIP/Postal Code
39245
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Halle Saale
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
22415
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Heinsberg
ZIP/Postal Code
52525
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Herne
ZIP/Postal Code
44649
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Magdeburg
ZIP/Postal Code
39110
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Muenchen
ZIP/Postal Code
80331
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Wertheim
ZIP/Postal Code
97877
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Wuerzburg
ZIP/Postal Code
97074
Country
Germany
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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
Learn more about this trial
Study of Efficacy and Safety of AIN457/Secukinumab in Patients With Rotator Cuff Tendinopathy
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