Dose Escalation Study of EG110A, Administered by Intradetrusor Injections to Adults With Neurogenic Detrusor Overactivity-related Incontinence Following Spinal Cord Injury Who Regularly Perform Clean Intermittent Catheterization

Phase 1

Recruiting

• Conditions: Neurogenic Detrusor Overactivity; Spinal Cord Injuries
• Interventions: Drug: EG110A

• Registration Number: NCT06596291
• Lead Sponsor: EG 427

Brief Summary

This is a first-in-human, Phase 1b/2a, open-label, dose-escalation study of a single treatment course consisting of multiple intradetrusor injections of EG110A in male and female adult participants with Neurogenic Detrusor Overactivity (NDO)-related incontinence following Spinal Cord Injury (SCI), who have persistent incontinence after standard of care therapy and who perform Clear Intermittent Catheterization (CIC) on a regular basis.

Detailed Description

This first-in-human clinical study, performed in SCI participants with Urinary Incontinence (UI) due to NDO and an inadequate response to current therapy, will evaluate the safety and tolerability of EG110A, and explore the potential doses for further clinical development. The present clinical study will also investigate the efficacy of EG110A via data collected in a bladder diary and via urodynamic assessments.

Study Timeline

• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-09-17
• Study First Posted: 2024-09-19
• Status Verified: 2024-11
• Study Start: 2025-01-08
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. Participant has stable supra-sacral traumatic SCI with American Spinal Injury Association (ASIA) Impairment Scale grade A, B, C, D or E which occurred at least 12 months before Screening.

2. Participant has UI due to urodynamically-confirmed NDO for at least 3 months prior to Screening.

3. Participant has:

   1. been treated for NDO for at least 3 months prior to Screening with an adequate course of oral pharmacotherapy(ies) and/or has had intolerable side-effects and/or exhibited an inadequate response in the opinion of the investigator and participant, i.e., at least 8 UI episodes in a week despite consistent use of the therapy. Participant does not wish to proceed to BoNT/A treatment, and their next step would be surgical intervention.

      OR

   2. had an inadequate response to BoNT/A treatment in the opinion of the investigator and participant, i.e., at least 8 UI episodes in a week, and the last BoNT/A treatment for their NDO was at least 9 months prior to the anticipated date of dosing (Day 1). Treatment with BoNT/A was not started more than 7 years ago, and their next step would be surgical intervention.

Main

Exclusion Criteria

1. Participant has previous or current tumor or malignancy affecting the spinal column or spinal cord, or any other nonstable cause of SCI.
2. Participant with active oral or genital herpes lesion. If the participant has an active oral or genital herpes infection this needs to be treated and healed first. The participant may be rescreened once the lesion has fully healed (at least 4 weeks after the lesion has healed).
3. Participant had cancer therapy or radiotherapy ≤ 4 weeks prior to Screening and has toxicities/AEs attributable to previously administered cancer therapies that have not resolved or stabilized.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EG110A (low dose)	EG110A	Patients who Received EG110A (low dose)
EG110A (Middle Dose)	EG110A	Patients who Received EG110A (middle dose)
EG110A (High Dose)	EG110A	Patients who Received EG110A (high dose)

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events (TEAEs)	1 year	Any participant who has a reported treatment-emergent adverse events (TEAEs)

Secondary Outcome Measures

Name	Time	Method
Urodynamic variables: changes at Weeks 12 and 52 compared to baseline	1 year	Changes in urodynamic variables will be assessed at Weeks 12 and 52.
Bladder Diary measures: changes in 7 days' mean daily episodes at Weeks 12 and 52 compared to baseline	1 year	7 day bladder diary with recording of urinary incontinence episodes, daily catheterization rates, and volume per catheterization.

Trial Locations

Locations (4)

Rancho Los Amigos National Rehabilitation Center; 🇺🇸 Downey, California, United States

University of Michigan Rogel Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States

Sidney Kimmel Medical College; 🇺🇸 Philadelphia, Pennsylvania, United States

UTHealth Houston / TIRR Memorial Hermann; 🇺🇸 Houston, Texas, United States