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

NCT03344640 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CAIN457X22012017-003099-30
• Study Type: interventional
• Target: 96
• Locations: 5 countries
• Sites: 12

Brief Summary

This was a randomized, double-blind, placebo-controlled, multi-center, Phase II study of s.c. secukinumab 300 mg in 98 randomized patients with overuse rotator-cuff tendinopathy without systemic inflammatory disease.

Conditions

Tendinopathy

Keywords

Overuse tendinopathy; shoulder; rotator cuff; IL-17A-Ab; AIN457X

Outcome Measures

Primary Outcomes (1)

• The Western Ontario Rotator Cuff (WORC) Patient Reported Outcome (PRO) Score at Week 14 in All Patients - Statistical Analysis Results of Total WORC Scores at Week 14

  WORC PRO score at week 14. 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. All Patients - Statistical analysis results of WORC scores at Week 14

  Week 14 (Day 99)

Secondary Outcomes (11)

• The Western Ontario Rotator Cuff (WORC) Patient Reported Outcome (PRO) Scores Over Time in All Patients

  Days 15, 29, 57, 85, 127, and End of Study

• Disability of Arm, Shoulder and Hand Questionnaire Score (QuickDASH) Over Time

  Days 15, 29, 57, 85, 99, 127, and End of Study

• American Shoulder and Elbow Surgeons (ASES) Score Over Time

  Days 15, 29, 57, 85, 99, 127, and End of Study

• Your Health Today Score Over Time

  Days 15, 29, 57, 85, 99, 127, and End of Study

• EQ-5D-5L Index Score Over Time

  Days 15, 29, 57, 85, 99, 127 and End of Study

Study Arms (2)

secukinumab

EXPERIMENTAL

AIN457 300 mg subcutaneously (s.c.) for 12 weeks

Drug: secukinumab

Placebo

PLACEBO COMPARATOR

Placebo subcutaneously for 12 weeks

Other: Placebo

Interventions

secukinumab DRUG

AIN457 300 mg subcutaneously for 12 weeks

Also known as: AIN457

secukinumab

Placebo OTHER

Placebo to match AIN457 subcutaneously for 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant, non-lactating female patients 18 to 65 years of age at randomization
• Presence of unilateral rotator cuff tendinopathy with:
• Symptoms present ≥6 weeks, but \<12 months prior to randomization
• 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
• 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
• 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
• The rotator-cuff tendinopathy must have been refractory to standard treatment, including NSAIDs and physiotherapy

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (12)

Novartis Investigative Site

Phoenix, Arizona, 85053, United States

Location

Novartis Investigative Site

La Mesa, California, 91942, United States

Location

Novartis Investigative Site

Clearwater, Florida, 33765, United States

Location

Novartis Investigative Site

Miami Lakes, Florida, 33014, United States

Location

Novartis Investigative Site

Tampa, Florida, 33603, United States

Location

Novartis Investigative Site

Brno, Czech Republic, 66250, Czechia

Location

Novartis Investigative Site

Kolín, Czech Republic, 280 02, Czechia

Location

Novartis Investigative Site

Prague, Czechia

Location

Novartis Investigative Site

Berlin, 10117, Germany

Location

Novartis Investigative Site

Hamburg, 22415, Germany

Location

Novartis Investigative Site

Leiden, 2333 CL, Netherlands

Location

Novartis Investigative Site

Glasgow, G51 4TF, United Kingdom

Location

Related Links

• A Plain Language Trial Summary is available on novartisclinicaltrials.com

MeSH Terms

Conditions

Tendinopathy

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Limitations and Caveats

In general "End of Study" is Day 169 (week 24). But in the study it was handled in a way, that whenever a subject discontinued the last visit was the EoS visit.

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

+1 (862) 778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients and investigators were blinded until EOS. Sponsor was blinded until after the analysis of the primary endpoint at week 14.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: November 17, 2017
• Study Start: December 15, 2017
• Primary Completion: August 2, 2019
• Study Completion: October 17, 2019
• Last Updated: October 8, 2021
• Results First Posted: December 9, 2020

Record last verified: 2021-10

Locations

GB (1); US (5); CZ (3); DE (2); NL (1)