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

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

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An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


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Study Type
Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03521232

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 1/Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
First Wave Bio, Inc.

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Giovanni MONTELEONE
Principal Investigator Affiliation U.O.C. Gastroenterologia ed Endoscopia Digestiva - Azienda Ospedaliera Universitaria PTV - Policlinico

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries Italy

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Ulcerative Colitis, Ulcerative Proctitis, Ulcerative Proctosigmoiditis

Contact a Trial Team

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International Sites

Centro Ricerche Cliniche di Verona, Verona, Italy

Status

Recruiting

Address

Centro Ricerche Cliniche di Verona

Verona, ,

Site Contact

Rachele Ciccocioppo, M.D.

gi.monteleone@med.uniroma2.it

39 0620900969

Roma, Italy

Status

Recruiting

Address

U.O.C. Gastroenterologia ed Endoscopia Digestiva - Azienda Ospedaliera Universitaria PTV - Policlinico

Roma, ,

Site Contact

Giovanni Monteleone, MD

gi.monteleone@med.uniroma2.it

39 0620900969

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