Back to resultsA Study of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative Proctosigmoiditis
Primary Purpose
Ulcerative Colitis, Ulcerative Proctitis, Ulcerative Proctosigmoiditis
Status
Terminated
Phase
Phase 1
Locations
Italy
Study Type
Interventional
Intervention
Niclosamide
Sponsored by
About this trial
This is an interventional other trial for Ulcerative Colitis
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects aged ≥ 18 years at the time of signing the informed consent;
- Must understand and voluntarily sign an informed consent from (ICF) prior to any study-related assessments/procedures being conducted.
- Must be able to adhere to the study visit schedule and other protocol requirements;
- Diagnosis of UP or UPS with a duration of at least 3 months prior to the Screening Visit
- MMS score ≥4 to < 8 (range: 0-9) prior to enrolment in the study.
- Availability to perform an endoscopy (colonoscopy or flexible rectosigmoidoscopy);
Exclusion Criteria:
- Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis, or diverticular disease-associated colitis;
- UC extended more than 40 cm from the anal verge;
- 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;
- 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;
- 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;
- Pregnant or breast feeding females;
- 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;
- Subjects who have received any investigational drug or device in the last 3 months;
- History of alcohol, drug, or chemical abuse within the last 6 months;
- Known hypersensitivity to niclosamide or any excipients in the formulation.
Sites / Locations
- Tor Vegata
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
150 mg/60 ml
450 mg/60 ml
Arm Description
Niclosamide enemas 150 mg/60 ml given twice daily for 6 weeks
Niclosamide enemas 450 mg/60 ml given twice daily for 6 weeks
Outcomes
Primary Outcome Measures
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.
Number of subjects with serious adverse reactions (i.e. treatment-related) during 6 weeks of treatment with Niclosamide enemas;
Number of subjects with grade ≥ 3 adverse reactions during 6 weeks of treatment with Niclosamide enemas;
Number of subjects with grade ≥ 2 adverse reactions during 6 weeks of treatment with Niclosamide enemas.
Secondary Outcome Measures
Number of subjects with clinical remission defined as MMS* ≤ 2 with no individual subscore >1 after 6 weeks of treatment
Full Information
NCT ID
NCT03521232
First Posted
April 17, 2018
Last Updated
November 28, 2022
Sponsor
First Wave BioPharma, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03521232
Brief Title
A Study of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative Proctosigmoiditis
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Covid-19
Study Start Date
May 15, 2018 (Actual)
Primary Completion Date
September 19, 2022 (Actual)
Study Completion Date
October 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Wave BioPharma, Inc.
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Ulcerative Proctitis, Ulcerative Proctosigmoiditis
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
150 mg/60 ml
Arm Type
Experimental
Arm Description
Niclosamide enemas 150 mg/60 ml given twice daily for 6 weeks
Arm Title
450 mg/60 ml
Arm Type
Experimental
Arm Description
Niclosamide enemas 450 mg/60 ml given twice daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Niclosamide
Intervention Description
enema given twice daily for 6 weeks
Primary Outcome Measure Information:
Title
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.
Description
Number of subjects with serious adverse reactions (i.e. treatment-related) during 6 weeks of treatment with Niclosamide enemas;
Number of subjects with grade ≥ 3 adverse reactions during 6 weeks of treatment with Niclosamide enemas;
Number of subjects with grade ≥ 2 adverse reactions during 6 weeks of treatment with Niclosamide enemas.
Time Frame
baseline to 6 weeks
Secondary Outcome Measure Information:
Title
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 Pre-specified Outcome Measures:
Title
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
Title
Change in sigmoidoscopic score (mucosal appearance) from baseline to 6 weeks of treatment
Time Frame
baseline to 6 weeks
Title
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
Title
Change in histology (Geboes index) from baseline to 6 weeks of treatment
Time Frame
baseline to 6 weeks
Title
Change in safety laboratory tests from baseline to 6 weeks of treatment
Description
the number of subjects with values low, normal, and high compared to the normal ranges pretreatment versus post-treatment will be provided
Time Frame
baseline to 6 weeks
Title
Change in 12-lead ECG parameters from baseline to 2, 4 and 6 weeks of treatment
Description
1. PR interval 2. RR interval 3. QRS interval 4 QT interval 5. HR interval 6. QtcF interval. All intervals summarized descriptively by visit
Time Frame
baseline to 2, 4 and 6 weeks of treatment
Title
Change in heart rate from baseline to 2, 4 and 6 weeks of treatment
Description
summarized descriptively by visit and presented as shift tables
Time Frame
baseline to 2, 4 and 6 weeks
Title
Change in quality of life (12-item Short-Form) from baseline to 6 weeks of treatment
Time Frame
baseline to 6 weeks
Title
Plasma levels of niclosamide measured before and after dosing
Time Frame
baseline to 6 weeks
Title
Change in sitting systolic and diastolic blood pressure from baseline to 2, 4 and 6 weeks of treatment
Description
summarized descriptively by visit and presented as shift tables
Time Frame
baseline to 2, 4 and 6 weeks
Title
Change in body temperature from baseline to 2, 4 and 6 weeks of treatment
Description
summarized descriptively by visit and presented as shift tables
Time Frame
baseline to 2, 4 and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subjects aged ≥ 18 years at the time of signing the informed consent;
Must understand and voluntarily sign an informed consent from (ICF) prior to any study-related assessments/procedures being conducted.
Must be able to adhere to the study visit schedule and other protocol requirements;
Diagnosis of UP or UPS with a duration of at least 3 months prior to the Screening Visit
MMS score ≥4 to < 8 (range: 0-9) prior to enrolment in the study.
Availability to perform an endoscopy (colonoscopy or flexible rectosigmoidoscopy);
Exclusion Criteria:
Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis, or diverticular disease-associated colitis;
UC extended more than 40 cm from the anal verge;
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;
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;
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;
Pregnant or breast feeding females;
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;
Subjects who have received any investigational drug or device in the last 3 months;
History of alcohol, drug, or chemical abuse within the last 6 months;
Known hypersensitivity to niclosamide or any excipients in the formulation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Pennington, M.D.
Organizational Affiliation
First Wave BioPharma
Official's Role
Study Director
Facility Information:
Facility Name
Tor Vegata
City
Rome
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative Proctosigmoiditis
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