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Study of Efficacy, Safety and Tolerability of AIN457 in Patients With Active Overuse Tendinopathy

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ClinicalTrials.gov Identifier: NCT03344640
Recruitment Status : Active, not recruiting
First Posted : November 17, 2017
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This is a randomized, double-blind, placebo-controlled, multi-center, Phase II study of s.c. secukinumab 300 mg in approximately 100 randomized patients with overuse rotator-cuff tendinopathy without systemic inflammatory disease

Condition or disease Intervention/treatment Phase
Tendinopathy Drug: AIN457 Other: Placebo Phase 2

Detailed Description:

This is a randomized, double-blind, placebo-controlled, multi-center, Phase II study of s.c. secukinumab 300 mg in approximately 100 randomized patients with overuse rotator-cuff tendinopathy without systemic inflammatory disease.

The study consists of a 4-week screening period, a 2-week run-in period, a 12-week treatment period and a 12-week follow-up period after last treatment The population will consist of patients with unilateral overuse (non-systemic inflammatory) shoulder tendinopathy, 18 - 65 years of age.

Safety assessments will include physical examinations, ECGs, vital signs, standard clinical laboratory evaluations (hematology, blood chemistry, and urinalysis), adverse event and serious adverse event monitoring.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The patient and investigator will be blinded throughout the study, while the sponsor will be blinded until after the analysis of the primary endpoint.
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase II, 24-week Study Investigating the Efficacy, Safety and Tolerability of AIN457 in Patients With Active Overuse Tendinopathy Refractory to Oral NSAIDs/Acetaminophen, Physiotherapy or Corticosteroid Injections
Actual Study Start Date : December 18, 2017
Actual Primary Completion Date : August 2, 2019
Estimated Study Completion Date : October 11, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis

Arm Intervention/treatment
Experimental: AIN457
AIN457 subcutaneously for 12 weeks
Drug: AIN457
AIN457 subcutaneously for 12 weeks
Other Name: secukinumab

Placebo Comparator: Placebo
Placebo subcutaneously for 12 weeks
Other: Placebo
Placebo to match AIN457 subcutaneously for 12 weeks




Primary Outcome Measures :
  1. The Western Ontario Rotator Cuff (WORC) patient reported outcome (PRO) score at week 14 [ Time Frame: Week 14 ]
    Patient Reported Outcome: The Western Ontario Rotator Cuff (WORC) patient reported outcome (PRO) score at week 14


Secondary Outcome Measures :
  1. The Western Ontario Rotator Cuff (WORC) patient reported outcome (PRO) score at week 2, 4, 8, 12, 18 and 24 [ Time Frame: Weeks 2, 4, 8, 12, 18 and 24 ]
    Patient Reported Outcome:The Western Ontario Rotator Cuff (WORC) score at Week 2, 4, 8, 12, 18 and 24

  2. Disability of Arm, Shoulder and Hand Questionnaire [ Time Frame: Weeks 2, 4, 8, 12, 14, 18 and 24 ]
    Patient Reported Outcome: Disability of Arm, Shoulder and Hand Questionnaire (QuickDASH) score This questionnaire asks about symptoms as well participant's ability to do certain activities range from 1 No difficulty to 5 Unable

  3. American Shoulder and Elbow Surgeons (ASES) [ Time Frame: Weeks 2, 4, 8, 12, 14, 18 and 24 ]
    Patient Reported Outcome: American Shoulder and Elbow Surgeons Shoulder Evaluation Form (ASES) score contains a physician-rated and patient-rated section; however, only the pain visual analog scale (VAS) and 10 functional questions are typically used to tabulate the reported ASES score. The total score - 100 maximum points - is weighted 50% for pain and 50% for function

  4. EuroQol-5D (EQ5D-5L) score at Weeks 2, 4, 8, 12, 14, 18 and 24 [ Time Frame: Weeks 2, 4, 8, 12, 14, 18 and 24 ]
    Patient Reported Outcome: EuroQol-5D (EQ5D-5L) score at Weeks 2, 4, 8, 12, 14, 18 and 24 Health questionnaire the scale is numbered 0 (worst health) to 100 (best health)

  5. Pain score using a Visual analog scale (VAS) scale at Weeks 2, 4, 8, 12, 14, 18 and 24 [ Time Frame: Weeks 2, 4, 8, 12, 14, 18 and 24 ]
    Patient Reported Outcome: Pain score using a VAS scale (considering the last 24 hours) at Weeks 2, 4, 8, 12, 14, 18 and 24 VAS scale is a range of scores from 0-100. A higher score indicates greater pain intensity

  6. Patient global assessment PGA) score using a VAS scale at Weeks 2, 4, 8, 12, 14, 18 and 24 [ Time Frame: Weeks 2, 4, 8, 12, 14, 18 and 24 ]
    Patient Reported Outcome: Patient global assessment (PGA) score using a VAS scale (considering the last 24 hours) at Weeks 2, 4, 8, 12, 14, 18 and 24 VAS is a range of scores from 0-100. A higher score indicates greater pain intensity

  7. Physician global assessment (PhGA) score using a VAS scale at Weeks 2, 4, 8, 12, 14, 18 and 24 [ Time Frame: Weeks 2, 4, 8, 12, 14, 18 and 24 ]
    Physician global assessment (PhGA) score using a VAS scale (considering the last 24 hours) at Weeks 2, 4, 8, 12, 14, 18 and 24 PhGA is a 5- or 6-point scoring system used to assess disease severity. score of 0 = clear and 5 = very severe

  8. structural changes in the rotator cuff tendinopathy-MRI Sein Assessment at Weeks 8, 14 and 24 [ Time Frame: Weeks 8, 14 and 24 ]
    structural changes in the rotator cuff tendinopathy-MRI Sein Assessment at Weeks 8, 14 and 24

  9. Pharmacokinetics -Cmin [ Time Frame: Day 1, Weeks 4, 12, 24 ]
    Cmin

  10. Immunogenicity assessment [ Time Frame: Day 1, Weeks 4, 12, 24 ]
    Anti-secukinumab antibodies assessment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or non-pregnant, non-lactating female patients 18 to 65 years of age at randomization
  2. Presence of unilateral rotator cuff tendinopathy with:

    1. Symptoms present ≥6 weeks, but <12 months prior to randomization
    2. Tendinopathy with no more than a 50% tear as established by ultrasound at screening (historic data acceptable if not older than 3 months) and MRI at baseline: Sein MRI tendinopathy scoring system grade I-III; with no tear or partial tear [maximum 50% tendon thickness (Bauer tendon thickness score maximum 2); AP length maximum 10 mm (Bauer tendon length score max 2)]. Maximum 50% of patients with partial tear
    3. Pain in the affected shoulder (at rest or on movement) on at least 3 days out of 7 days in the past week prior to baseline and a score of ≥4 out of 10 on a VAS pain scale
    4. Positive "Painful Arc Test" on examination and/or nightly pain in the affected shoulder on at least 4 out of 7 days in the past week prior to baseline
  3. The rotator-cuff tendinopathy must have been refractory to standard treatment, including NSAIDs and physiotherapy -

Exclusion Criteria:

1. Rheumatologic, inflammatory diseases, including but not limited to: PsA, AS and RA 2. Previous shoulder surgery in affected shoulder 3. History of adhesive capsulitis/frozen shoulder or calcification in the tendon (in affected or contralateral shoulder) confirmed by X-Ray, historic X-Rays can be used if performed within 3 months of baseline 4. Symptomatic osteoarthritis of the shoulder (gleno-humeral, acromioclavicular) (in affected or contralateral shoulder confirmed by X-Ray, historic X-Rays can be used if performed within 3 months of baseline 5. Neck conditions, including but not limited to cervical spine syndrome, which in the opinion of the investigator, may explain the patient's symptoms 6. Previous platelet rich plasma injections within the last 12 months prior to randomization 7. Previous treatment with any cell-depleting therapies including but not limited to anti- CD20, investigational agents (e.g. Campath, anti-CD4, anti-CD5, anti-CD3, anti-CD19) 8. Previous exposure to any biologic immunomodulating agents, including but not limited to TNFalpha inhibitors (including, but not limited to adalimumab, infliximab), or biologics targeting IL-17 (including, but not limited to secukinumab, ixekizumab or brodalumab) or the IL-17 receptor within the last 12 months prior to baseline 9. Any intraarticular/subacromial corticosteroid treatment within 8 weeks prior to randomization and more than 3 injections for the current tendinopathy. Oral, intramuscular or i.v. corticosteroid treatment within the last 12 months prior to randomization

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03344640


Locations
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United States, Arizona
Novartis Investigative Site
Phoenix, Arizona, United States, 85053
Novartis Investigative Site
Tucson, Arizona, United States, 85712
United States, California
Novartis Investigative Site
La Mesa, California, United States, 91942
United States, Florida
Novartis Investigative Site
Clearwater, Florida, United States, 33765
Novartis Investigative Site
Miami Lakes, Florida, United States, 33014
Novartis Investigative Site
Tampa, Florida, United States, 33603
United States, Illinois
Novartis Investigative Site
Chicago, Illinois, United States, 60612
Czechia
Novartis Investigative Site
Brno, Czech Republic, Czechia, 66250
Novartis Investigative Site
Kolin, Czech Republic, Czechia, 280 02
Novartis Investigative Site
Praha, Czechia
Germany
Novartis Investigative Site
Berlin, Germany, 10117
Novartis Investigative Site
Hamburg, Germany, 22415
Netherlands
Novartis Investigative Site
Leiden, Netherlands, 2333 CL
United Kingdom
Novartis Investigative Site
Glasgow, United Kingdom, G51 4TF
Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03344640     History of Changes
Other Study ID Numbers: CAIN457X2201
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Overuse tendinopathy
shoulder
rotator cuff
IL-17A-Ab
AIN457X
Additional relevant MeSH terms:
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Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs