Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03521232
Recruitment Status : Recruiting
First Posted : May 11, 2018
Last Update Posted : May 26, 2020
Sponsor:
Information provided by (Responsible Party):
First Wave Bio, Inc.

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Ulcerative Proctitis Ulcerative Proctosigmoiditis Drug: Niclosamide Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase I/IIA, Open-Label, Three-Stage Study to Investigate the Safety, the Efficacy and the Pharmacokinetics of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative Procto-Sigmoiditis
Actual Study Start Date : May 15, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 150 mg/60 ml
Niclosamide enemas 150 mg/60 ml given twice daily for 6 weeks
Drug: Niclosamide
enema given twice daily for 6 weeks

Experimental: 450 mg/60 ml
Niclosamide enemas 450 mg/60 ml given twice daily for 6 weeks
Drug: Niclosamide
enema given twice daily for 6 weeks




Primary Outcome Measures :
  1. Safety and tolerability of Niclosamide enemas 150 mg/60 ml and 450 mg/60 ml graded according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0. [ Time Frame: baseline to 6 weeks ]
    1. Number of subjects with serious adverse reactions (i.e. treatment-related) during 6 weeks of treatment with Niclosamide enemas;
    2. Number of subjects with grade ≥ 3 adverse reactions during 6 weeks of treatment with Niclosamide enemas;
    3. Number of subjects with grade ≥ 2 adverse reactions during 6 weeks of treatment with Niclosamide enemas.


Secondary Outcome Measures :
  1. Number of subjects with clinical remission defined as MMS* ≤ 2 with no individual subscore >1 after 6 weeks of treatment [ Time Frame: baseline to 6 weeks ]

Other Outcome Measures:
  1. Change in signs and symptoms (rectal bleeding and stool frequency) from baseline to 2, 4 and 6 weeks of treatment [ Time Frame: from baseline to 2, 4 and 6 weeks ]
  2. Change in sigmoidoscopic score (mucosal appearance) from baseline to 6 weeks of treatment [ Time Frame: baseline to 6 weeks ]
  3. Change in hs-CRP and fecal calprotectin from baseline to 2, 4 and 6 weeks of treatment [ Time Frame: baseline to 2, 4 and 6 weeks ]
  4. Change in histology (Geboes index) from baseline to 6 weeks of treatment [ Time Frame: baseline to 6 weeks ]
  5. Change in safety laboratory tests from baseline to 6 weeks of treatment [ Time Frame: baseline to 6 weeks ]
    the number of subjects with values low, normal, and high compared to the normal ranges pretreatment versus post-treatment will be provided

  6. Change in 12-lead ECG parameters from baseline to 2, 4 and 6 weeks of treatment [ Time Frame: baseline to 2, 4 and 6 weeks of treatment ]
    1. PR interval 2. RR interval 3. QRS interval 4 QT interval 5. HR interval 6. QtcF interval. All intervals summarized descriptively by visit

  7. Change in heart rate from baseline to 2, 4 and 6 weeks of treatment [ Time Frame: baseline to 2, 4 and 6 weeks ]
    summarized descriptively by visit and presented as shift tables

  8. Change in quality of life (12-item Short-Form) from baseline to 6 weeks of treatment [ Time Frame: baseline to 6 weeks ]
  9. Plasma levels of niclosamide measured before and after dosing [ Time Frame: baseline to 6 weeks ]
  10. Change in sitting systolic and diastolic blood pressure from baseline to 2, 4 and 6 weeks of treatment [ Time Frame: baseline to 2, 4 and 6 weeks ]
    summarized descriptively by visit and presented as shift tables

  11. Change in body temperature from baseline to 2, 4 and 6 weeks of treatment [ Time Frame: baseline to 2, 4 and 6 weeks ]
    summarized descriptively by visit and presented as shift tables



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03521232


Contacts
Layout table for location contacts
Contact: Giovanni MONTELEONE, M.D. 39 0620900969 gi.monteleone@med.uniroma2.it

Locations
Layout table for location information
Italy
Fondazione IRCCS Policlinico San Matteo - Phase I Clinical Trial Unit And Experimental Therapy Recruiting
Pavia, Italy
Contact: Antonio Disabatino         
U.O.C. Gastroenterologia ed Endoscopia Digestiva - Azienda Ospedaliera Universitaria PTV - Policlinico Suspended
Roma, Italy
Centro Ricerche Cliniche di Verona Recruiting
Verona, Italy
Contact: Rachele Ciccocioppo, M.D.         
Sponsors and Collaborators
First Wave Bio, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Giovanni MONTELEONE U.O.C. Gastroenterologia ed Endoscopia Digestiva - Azienda Ospedaliera Universitaria PTV - Policlinico
Layout table for additonal information
Responsible Party: First Wave Bio, Inc.
ClinicalTrials.gov Identifier: NCT03521232    
Other Study ID Numbers: FW-UC-2017
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: May 26, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Colitis, Ulcerative
Proctitis
Proctocolitis
Ulcer
Colitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Rectal Diseases
Sigmoid Diseases
Niclosamide
Anticestodal Agents
Antiplatyhelmintic Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Antinematodal Agents