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Safety, Tolerability, and Pharmacokinetics of Single Dose TenoMiR as a Treatment for Tennis Elbow

Primary Purpose

Tennis Elbow

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

TenoMiR (Low Dose)

TenoMiR (Medium Dose)

TenoMiR (High Dose)

Placebo

About this trial

This is an interventional treatment trial for Tennis Elbow

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject has a clinical diagnosis of lateral epicondylitis.
Aside from lateral epicondylitis, the subject is otherwise healthy as determined by a responsible physician, based on medical history, physical examinations, concomitant medication, vital signs, 12-lead ECGs and clinical laboratory evaluations. Laboratory values may be re-tested once at the discretion of the Investigator.
Subject's symptoms can be reproduced with resisted supination or wrist dorsiflexion (as confirmed by tenderness at lateral epicondyle and positive pick up back of chair sign).
Subject's symptoms have persisted for at least 6 weeks to 6 months, despite conservative treatment that includes 1 or combinations of:
1. Physical therapy
2. Splinting
3. NSAIDs

Exclusion Criteria:

Subjects with any of the following will be excluded from study participation:

Subject has undergone previous corticosteroid injection therapy to the affected elbow in less than 6 months prior to enrolment.
Subjects unwilling or unable to discontinue use of pain medication (opiate or NSAID) from at least 1 week prior to Investigational Medicinal Product (IMP) administration.
Subject has received previous Platelet-Rich Plasma (PRP) injection to the affected elbow.
Subject uses or has recent use of medications known to affect the skeleton (e.g., glucocorticoid usage >5 mg/day, fluoroquinolone antibiotics).
Subject has undergone surgical intervention to the affected elbow for the treatment of lateral epicondylitis.

Sites / Locations

MAC Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment

Placebo

Arm Description

TenoMiR intralesional injection

0.9% saline intralesional injection

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of clinical laboratory abnormalities between TenoMiR versus placebo.

Comparison of clinical laboratory abnormalities between TenoMiR versus placebo as measured by blood chemistry, haematology, coagulation, serology and urinalysis.

Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of changes in vital signs between TenoMiR versus placebo.

Comparison of changes in vital signs between TenoMiR versus placebo as measured by supine vital signs including pulse rate, blood pressure, respiration rate and oral temperature.

Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of changes in 12 lead ECG parameters between TenoMiR versus placebo.

Comparison of changes in 12 lead ECG parameters as measured by Heart Rate and PR, RR, QRS, QT and QT intervals.

Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of physical examination between TenoMiR versus placebo.

Comparison of changes in physical examination between TenoMiR versus placebo as measured by height, BMI, and body weight, and assessments of the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular system, abdomen (liver and spleen), lymph nodes and extremities.

Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of skin score assessment between TenoMiR versus placebo.

Comparison of changes in skin score assessment of injection site between TenoMiR versus placebo as measured by for erythema, pain, tenderness and swelling.

Secondary Outcome Measures

Single dose pharmacokinetics (PK) of TenoMiR administration in subjects with lateral epicondylitis (Cmax).

Plasma PK by maximum drug plasma concentration (Cmax).

Single dose pharmacokinetics (PK) of TenoMiR administration in subjects with lateral epicondylitis (tmax).

Plasma PK by time to reach Cmax (tmax).

Single dose pharmacokinetics (PK) of TenoMiR administration in subjects with lateral epicondylitis (AUC).

Plasma PK by area under the plasma vs. concentration time curve (AUC).

Visual Analogue Score (VAS) pain score

Changes in pain score per group

Disabilities of the Arm, Shoulder, and Hand (Quick DASH) score

Changes in Quick DASH per group

American Shoulder and Elbow Surgeons Elbow (ASES-E) score

Changes in ASES-E per group

Patient Rated Tennis Elbow Evaluation (PRTEE) score

Changes in PRTEE per group

Ultrasound assessment

Change in analysis of focal hypoechoic areas within the tendon per group

Full Information

NCT ID

NCT04670289

First Posted

November 26, 2020

Last Updated

September 16, 2021

Sponsor

Causeway Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT04670289

Brief Title

Safety, Tolerability, and Pharmacokinetics of Single Dose TenoMiR as a Treatment for Tennis Elbow

Official Title

A Phase 1, Single-Centre, Randomised, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of TenoMiR Injections in Subjects With Lateral Epicondylitis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

August 14, 2020 (Actual)

Primary Completion Date

May 19, 2021 (Actual)

Study Completion Date

August 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Causeway Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This study is testing a drug called TenoMiR that is being developed for the treatment of tennis elbow (lateral epicondylitis). The study drug is a new compound that works by improving the quality of the collagen which helps repair damage to the elbow. The study drug is being developed in the hope of providing a more reliable treatment than those currently available and can be given at the time of first diagnosis, so that recovery can begin as soon as possible.

Detailed Description

TenoMiR a chemically synthesised mimic of microRNA-29a (miR29a) which has improved stability, activity and cellular uptake while being non-immunogenic, has been created to restore miR29a levels back to pre-injury levels. TenoMiR is unique in directly targeting the key changes in collagen production associated with tendinopathy. Unlike other therapies, TenoMiR has a well-defined mode-of-action that is supported by a wealth of scientific data. Moreover, treatment with TenoMiR does not require invasive biopsies and can be delivered at the point of initial diagnosis initiating recovery at the very earliest time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tennis Elbow

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Prospective, Controlled, Randomised, Double Blind, Single Centre Trial

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

TenoMiR intralesional injection

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

0.9% saline intralesional injection

Intervention Type

Drug

Intervention Name(s)

TenoMiR (Low Dose)

Other Intervention Name(s)

CWT-001

Intervention Description

Mimic of miR29a

Intervention Type

Drug

Intervention Name(s)

TenoMiR (Medium Dose)

Other Intervention Name(s)

CWT-001

Intervention Description

Mimic of miR29a

Intervention Type

Drug

Intervention Name(s)

TenoMiR (High Dose)

Other Intervention Name(s)

CWT-001

Intervention Description

Mimic of miR29a

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

0.9% saline

Primary Outcome Measure Information:

Title

Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of clinical laboratory abnormalities between TenoMiR versus placebo.

Description

Comparison of clinical laboratory abnormalities between TenoMiR versus placebo as measured by blood chemistry, haematology, coagulation, serology and urinalysis.

Time Frame

14 days

Title

Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of changes in vital signs between TenoMiR versus placebo.

Description

Comparison of changes in vital signs between TenoMiR versus placebo as measured by supine vital signs including pulse rate, blood pressure, respiration rate and oral temperature.

Time Frame

14 days

Title

Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of changes in 12 lead ECG parameters between TenoMiR versus placebo.

Description

Comparison of changes in 12 lead ECG parameters as measured by Heart Rate and PR, RR, QRS, QT and QT intervals.

Time Frame

14 days

Title

Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of physical examination between TenoMiR versus placebo.

Description

Time Frame

14 days

Title

Incidence of Treatment-Emergent Adverse Events (AEs) as assessed by comparison of skin score assessment between TenoMiR versus placebo.

Description

Comparison of changes in skin score assessment of injection site between TenoMiR versus placebo as measured by for erythema, pain, tenderness and swelling.

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Single dose pharmacokinetics (PK) of TenoMiR administration in subjects with lateral epicondylitis (Cmax).

Description

Plasma PK by maximum drug plasma concentration (Cmax).

Time Frame

90 days

Title

Single dose pharmacokinetics (PK) of TenoMiR administration in subjects with lateral epicondylitis (tmax).

Description

Plasma PK by time to reach Cmax (tmax).

Time Frame

90 days

Title

Single dose pharmacokinetics (PK) of TenoMiR administration in subjects with lateral epicondylitis (AUC).

Description

Plasma PK by area under the plasma vs. concentration time curve (AUC).

Time Frame

90 days

Title

Visual Analogue Score (VAS) pain score

Description

Changes in pain score per group

Time Frame

90 days

Title

Disabilities of the Arm, Shoulder, and Hand (Quick DASH) score

Description

Changes in Quick DASH per group

Time Frame

90 days

Title

American Shoulder and Elbow Surgeons Elbow (ASES-E) score

Description

Changes in ASES-E per group

Time Frame

90 days

Title

Patient Rated Tennis Elbow Evaluation (PRTEE) score

Description

Changes in PRTEE per group

Time Frame

90 days

Title

Ultrasound assessment

Description

Change in analysis of focal hypoechoic areas within the tendon per group

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject has a clinical diagnosis of lateral epicondylitis. Aside from lateral epicondylitis, the subject is otherwise healthy as determined by a responsible physician, based on medical history, physical examinations, concomitant medication, vital signs, 12-lead ECGs and clinical laboratory evaluations. Laboratory values may be re-tested once at the discretion of the Investigator. Subject's symptoms can be reproduced with resisted supination or wrist dorsiflexion (as confirmed by tenderness at lateral epicondyle and positive pick up back of chair sign). Subject's symptoms have persisted for at least 6 weeks to 6 months, despite conservative treatment that includes 1 or combinations of: Physical therapy Splinting NSAIDs Exclusion Criteria: Subjects with any of the following will be excluded from study participation: Subject has undergone previous corticosteroid injection therapy to the affected elbow in less than 6 months prior to enrolment. Subjects unwilling or unable to discontinue use of pain medication (opiate or NSAID) from at least 1 week prior to Investigational Medicinal Product (IMP) administration. Subject has received previous Platelet-Rich Plasma (PRP) injection to the affected elbow. Subject uses or has recent use of medications known to affect the skeleton (e.g., glucocorticoid usage >5 mg/day, fluoroquinolone antibiotics). Subject has undergone surgical intervention to the affected elbow for the treatment of lateral epicondylitis.

Facility Information:

Facility Name

MAC Clinical Research

City

Manchester

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Safety, Tolerability, and Pharmacokinetics of Single Dose TenoMiR as a Treatment for Tennis Elbow

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