A Phase 2b/3 Study of TPX-115 on Partial-thickness Rotator Cuff Tear

A Multi-center, Randomized, Double Blinded, Placebo-controlled, Phase 2b/3 Clinical Trial to Evaluate the Safety and Efficacy of TPX-115 in Patients With Partial-thickness Rotator Cuff Tear

Rotator cuff tear is one of the most common shoulder diseases and conservative treatment is commonly used for tears involving ≤50% of tendon thickness. Since conventional conservative treatments are not fundamental to repair tendon tissue, there is a growing need of new therapy to improve structural outcome. This study assesses the safety and efficacy of allogeneic fibroblasts on partial-thickness rotator cuff tear. The primary outcome is change in Constant Score (CS) at 24 weeks after TPX-115 injection. Secondary outcomes include changes from baseline in CS, Visual Analogue Score (VAS) pain score, American Shoulder and Elbow Surgeons (ASES) score, Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH), Simple Shoulder Test (SST), and functional evaluations including Range of Motion (ROM) at 4, 12, 24 and 52 weeks after administration and structural evaluation using MRI at 24 and 52 weeks after injection.

Study Overview

• Status: Recruiting
• Conditions: Partial Thickness Rotator Cuff Tear
• Intervention / Treatment: Biological: TPX-115; Other: Placebo (Saline)

• Study Type: Interventional
• Enrollment (Estimated): 166
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Jikhyon Han, Ph.D.; Phone Number: +82-2-818-2900; Email: jhhan@tegoscience.com

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: Joo Han Oh, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Be 19 years of age or older.
2. Have partial-thickness rotator cuff tear, ≤50% of tendon thickness or of Ellman grade II assessed by MRI.
3. Have unilateral shoulder pain, muscle weakness and limited active range of motion lasting more than 3 months despite conservative treatment
4. VAS pain score ≥4 at screening.
5. Understand fully the study and voluntarily sign the informed consent for participation in the study.

Exclusion Criteria:

1. Regardless of partial-thickness rotator cuff tear, have full-thickness rotator cuff tear confirmed by MRI.

2. Have been treated with the following

   • Have had painkiller within 1 week prior to screening visit.
   • Have had received systemic steroid or immunosuppressive agents within 4 weeks prior to screening visit.
   • Have had subacromial or intra-articular injections on the affected shoulder within 3 months prior to screening visit.
   • Have shoulder surgery on the rotator cuff tear or had received drug that included growth factor, within 6 months prior to screening visit.

3. Have been diagnosed with the following diseases.

   • Inflammatory joint diseases
   • Other shoulder diseases which may cause shoulder pain or functional disorder
   • Autoimmune diseases
   • Active hepatitis B or C
   • HIV Ab positive
   • Malignant tumors within the last 5 years
   • Coagulopathy
   • Genetic disorders related to fibroblasts of collagen
   • Other serious diseases deemed to affect the results of the study
4. Have allergies to bovine proteins or gentamicin.
5. Be pregnant, breastfeeding, planning pregnancy or unwilling to use of contraceptive suggested in this study.
6. Have participated in other clinical trials and received investigational agents within 4 weeks of this study.
7. Be deemed inadequate for the study by investigators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TPX-115; Subjects receive ultrasound-guided intratendinous injection of TPX-115	Biological: TPX-115; Ultrasound-guided intratendinous injection of allogeneic fibroblasts (TPX-115)
Placebo Comparator: Placebo (Saline); Subjects receive ultrasound-guided intratendinous placebo injection	Other: Placebo (Saline); Ultrasound-guided intratendinous placebo injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in shoulder score of Constant score (CS)	The CS total score (100) = Pain (15) + Activity of Daily Living (20) + Mobility (40) + Strength(25)	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in shoulder score of Constant score (CS)	The CS total score (100) = Pain (15) + Activity of Daily Living (20) + Mobility (40) + Strength(25).	4, 12, 52 weeks
hange in pain score of Visual Analogue Scale (VAS)	VAS pain score is measured on a scale of 0 (no pain) to 10 (worst pain imaginable).	4, 12, 24, 52 weeks
Change of American Shoulder and Elbow Surgeons (ASES) Shoulder Score	ASES shoulder score is derived from the visual analogue scale score for pain and the activities of daily living score. The total score(100 maximum points) is weighted 50% for pain and 50% for function.	4, 12, 24, 52 weeks
Change of Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH) Outcome Measure	The QuickDASH is a shortened version of the DASH Outcome Measure. Instead of 30 items, the QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.	4, 12, 24, 52 weeks
Change in Simple Shoulder Test (SST) Score	SST assesses functional disability of the shoulder (function related to pain, function/strength and Range of Motion).	4, 12, 24, 52 weeks
Change in Range of Motion (ROM)	Measurement of ROM for forward elevation, external rotation at 90º abduction, external rotation at side and internal rotation at back.	4, 12, 24, 52 weeks
Change in Ellman grade on Magnetic Resonance Image (MRI)	Ellman grade is assessed by an independent evaluator.	24, 52 weeks
Change of tendinosis on MRI	Tendinosis is assessed with tendinosis grading system by an independent evaluator. (0: normal, 1: mild, 2: moderate, 3: marked)	24, 52 weeks

Collaborators and Investigators

• Sponsor: Tego Science, Inc.
• Investigators: Principal Investigator: Joo Han Oh, M.D., Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: May 10, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: TG-TPX-115-22-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No