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

Last updated: July 15, 2025
Sponsor: EG 427
Overall Status: Active - Recruiting

Phase

1/2

Condition

Spinal Cord Injuries

Treatment

EG110A

Clinical Study ID

NCT06596291
EG110A-001-01
HT94252510505_CDMRP
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Main Inclusion Criteria:

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

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

  3. Participant has:

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

  5. had an inadequate response to BoNT/A treatment in the opinion of theinvestigator and participant, i.e., at least 8 UI episodes in a week, and thelast BoNT/A treatment for their NDO was at least 6 months prior to screening.Treatment with BoNT/A was not started more than 7 years ago, and their nextstep would be surgical intervention.

Exclusion

Main Exclusion Criteria:

  1. Participant has previous or current tumor or malignancy affecting the spinal columnor spinal cord, or any other nonstable cause of SCI.

  2. Participant with active oral or genital herpes lesion. If the participant has anactive 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 weeksafter the lesion has healed).

  3. Participant had cancer therapy or radiotherapy ≤ 4 weeks prior to Screening and hastoxicities/AEs attributable to previously administered cancer therapies that havenot resolved or stabilized.

Study Design

Total Participants: 16
Treatment Group(s): 1
Primary Treatment: EG110A
Phase: 1/2
Study Start date:
January 08, 2025
Estimated Completion Date:
April 30, 2027

Study 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.

Connect with a study center

  • Rancho Los Amigos National Rehabilitation Center

    Downey, California 90242
    United States

    Active - Recruiting

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Sidney Kimmel Medical College

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • TIRR Memorial Hermann

    Houston, Texas 77030
    United States

    Site Not Available

  • UTHealth Houston / TIRR Memorial Hermann

    Houston, Texas 77030
    United States

    Active - Recruiting

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