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New treatment option for Partial Thickness Rotator Cuff Tear
Official title A Phase 2b/3 Study of TPX-115 on Partial-thickness Rotator Cuff Tear
ClinicalTrials.gov ID: NCT06414005
What this study is testing
What is TPX-115?
TPX-115 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for partial thickness rotator cuff tear.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Be 19 years of age or older.
- Have partial-thickness rotator cuff tear, ≤50% of tendon thickness or of Ellman grade II assessed by MRI.
- Have unilateral shoulder pain, muscle weakness and limited active range of motion lasting more than 3 months despite conservative treatment
- VAS pain score ≥4 at screening.
- Understand fully the study and voluntarily sign the informed consent for participation in the study.
You likely can't join if
- Regardless of partial-thickness rotator cuff tear, have full-thickness rotator cuff tear confirmed by MRI.
- 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.
See the full eligibility criteria
- Be 19 years of age or older.
- Have partial-thickness rotator cuff tear, ≤50% of tendon thickness or of Ellman grade II assessed by MRI.
- Have unilateral shoulder pain, muscle weakness and limited active range of motion lasting more than 3 months despite conservative treatment
- VAS pain score ≥4 at screening.
- Understand fully the study and voluntarily sign the informed consent for participation in the study.
- Regardless of partial-thickness rotator cuff tear, have full-thickness rotator cuff tear confirmed by MRI.
- 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.
- 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
- Have allergies to bovine proteins or gentamicin.
- Be pregnant, breastfeeding, planning pregnancy or unwilling to use of contraceptive suggested in this study.
- Have participated in other clinical trials and received investigational agents within 4 weeks of this study.
- Be deemed inadequate for the study by investigators.
The study team makes the final eligibility decision.
Where it's taking place
- Seongnam-si, Gyeonggi-do, South Korea
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seongnam-si, Gyeonggi-do, South Korea; Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.