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 : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
First Wave Bio, Inc.

Tracking Information
First Submitted Date  ICMJE April 17, 2018
First Posted Date  ICMJE May 11, 2018
Last Update Posted Date September 7, 2020
Actual Study Start Date  ICMJE May 15, 2018
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2018)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 9, 2018)
  • 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 ]
  • Change in sigmoidoscopic score (mucosal appearance) from baseline to 6 weeks of treatment [ Time Frame: baseline to 6 weeks ]
  • 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 ]
  • Change in histology (Geboes index) from baseline to 6 weeks of treatment [ Time Frame: baseline to 6 weeks ]
  • 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
  • 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
  • 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
  • Change in quality of life (12-item Short-Form) from baseline to 6 weeks of treatment [ Time Frame: baseline to 6 weeks ]
  • Plasma levels of niclosamide measured before and after dosing [ Time Frame: baseline to 6 weeks ]
  • 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
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: May 9, 2018)
  • 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 ]
  • Change in sigmoidoscopic score (mucosal appearance) from baseline to 6 weeks of treatment [ Time Frame: baseline to 6 weeks ]
  • 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 ]
  • Change in histology (Geboes index) from baseline to 6 weeks of treatment [ Time Frame: baseline to 6 weeks ]
  • 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
  • Change in 12-lead ECG from baseline to 2, 4 and 6 weeks of treatment [ Time Frame: baseline to 2, 4 and 6 weeks of treatment ]
  • 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
  • Change in quality of life (12-item Short-Form) from baseline to 6 weeks of treatment [ Time Frame: baseline to 6 weeks ]
  • Plasma levels of niclosamide measured before and after dosing [ Time Frame: baseline to 6 weeks ]
  • Change in 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
  • 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
 
Descriptive Information
Brief Title  ICMJE A Study of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative Proctosigmoiditis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Ulcerative Colitis
  • Ulcerative Proctitis
  • Ulcerative Proctosigmoiditis
Intervention  ICMJE Drug: Niclosamide
enema given twice daily for 6 weeks
Study Arms  ICMJE
  • Experimental: 150 mg/60 ml
    Niclosamide enemas 150 mg/60 ml given twice daily for 6 weeks
    Intervention: Drug: Niclosamide
  • Experimental: 450 mg/60 ml
    Niclosamide enemas 450 mg/60 ml given twice daily for 6 weeks
    Intervention: Drug: Niclosamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 9, 2018)
51
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Giovanni MONTELEONE, M.D. 39 0620900969 gi.monteleone@med.uniroma2.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03521232
Other Study ID Numbers  ICMJE FW-UC-2017
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party First Wave Bio, Inc.
Study Sponsor  ICMJE First Wave Bio, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Giovanni MONTELEONE U.O.C. Gastroenterologia ed Endoscopia Digestiva - Azienda Ospedaliera Universitaria PTV - Policlinico
PRS Account First Wave Bio, Inc.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP