A Study of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative Proctosigmoiditis

NCT ID: NCT03521232

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-15
• Study Completion Date: 2022-10-04

Brief Summary

This will be a phase I/IIa, open-label, three-stage, single center study aimed at investigating the safety, the efficacy (clinical and endoscopic effects) and the pharmacokinetics of Niclosamide enema 150 mg/60 ml and 450 mg/60 ml in subjects with mild-to-moderate UP and UPS, defined as a Modified Mayo Score (MMS) ≥ 4 and < 8, with a stool frequency subscore (SFS) ≥ 1, a rectal bleeding sub-score (RBS) = 1 or 2, and an endoscopic subscore (mucosal appearance) = 1 or 2. At the endoscopic sub-score any degree of friability will be classified as having a sub-scale score of 2.

Conditions

Ulcerative Colitis; Ulcerative Proctitis; Ulcerative Proctosigmoiditis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

150 mg/60 ml

Niclosamide enemas 150 mg/60 ml given twice daily for 6 weeks

Group Type: EXPERIMENTAL

Niclosamide

Intervention Type: DRUG

enema given twice daily for 6 weeks

450 mg/60 ml

Niclosamide enemas 450 mg/60 ml given twice daily for 6 weeks

Group Type: EXPERIMENTAL

Niclosamide

Intervention Type: DRUG

enema given twice daily for 6 weeks

Interventions

Niclosamide

enema given twice daily for 6 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female subjects aged ≥ 18 years at the time of signing the informed consent;

2. Must understand and voluntarily sign an informed consent from (ICF) prior to any study-related assessments/procedures being conducted.

3. Must be able to adhere to the study visit schedule and other protocol requirements;

4. Diagnosis of UP or UPS with a duration of at least 3 months prior to the Screening Visit

5. MMS score ≥4 to < 8 (range: 0-9) prior to enrolment in the study.

6. Availability to perform an endoscopy (colonoscopy or flexible rectosigmoidoscopy);

Exclusion Criteria

1. Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis, or diverticular disease-associated colitis;

2. UC extended more than 40 cm from the anal verge;

3. Subjects who have had surgery as a treatment for UC or who, in the opinion of the Investigator, are likely to require surgery for UC during the study;

4. History of any clinically significant neurological, renal, hepatic, gastrointestinal, pulmonary, metabolic, psychiatric, endocrine, hematological disorder or disease or any other medical condition that, in the Investigator's opinion, would preclude participation in the study;

5. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she was to participate in the study or confounds the ability to interpret data from the study;

6. Pregnant or breast feeding females;

7. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections (including but not limited to tuberculosis, atypical mycobacterial disease, and herpes zoster), human immunodeficiency virus (HIV), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) or oral antibiotics within 4 weeks of screening;

8. Subjects who have received any investigational drug or device in the last 3 months;

9. History of alcohol, drug, or chemical abuse within the last 6 months;

10. Known hypersensitivity to niclosamide or any excipients in the formulation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Entero Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Pennington, M.D.

Role: STUDY_DIRECTOR

First Wave BioPharma

Locations

Tor Vegata

Rome, , Italy

Countries

Italy

Other Identifiers

FW-UC-2017

Identifier Type: -

Identifier Source: org_study_id