Active ulcerative proctitis or ulcerative procto-sigmoiditis MedDRA version: 20.0 Level: PT Classification code 10036783 Term: Proctitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0 Level: LLT Classification code 10036789 Term: Proctosigmoiditis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1 Level: LLT Classification code 10045362 Term: Ulcerative (chronic) proctosigmoiditis System Organ Class: 10017947 - Gastrointes
Conditions
Interventions
Product Name: Niclosamide enema 150 mg/60 ml
Product Code: [Niclosamide enema 150 mg/60 ml]
Pharmaceutical Form: Rectal suspension
INN or Proposed INN: NICLOSAMIDE
CAS Number: 50-65-7
Current Sponsor
Sponsors
FIRST WAVE BIOPHARMA INCORPORATION
Eligibility
Sex/Gender
All
Inclusion 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 UC (subcategories UP and/or UPS) with a duration of at least 3 months prior to the Screening Visit, extending at least 5 cm, but no further 40 cm from the anal verge; 5. MMS score =4 to 2 ¿ ULN, one repeated test is allowed during the screening period; • Total bilirubin =2 mg/dL (= 34 ¿mol/L) or albumin > lower than limit of normal (LLN). If initial test result is >2 g/dL, one repeated test is allowed during the screening period; • Hemoglobin = 9 g/dL (=5.6 mmol/L); 9. Females of childbearing potential (FCBP) must have a negative pregnancy test at screening and the Baseline Visit. While receiving the investigational medicinal product (IMP) and for at least 28 days after taking the last dose of IMP, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below: • Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner’s vasectomy; OR • Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide; 10. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or non-latex condom NOT made out of natural [animal] membrane [for example, polyurethane]) while receiving the IMP and for at least 28 days after taking the last dose of IMP Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
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. Evidence of pathogenic enteric infection; 5. History of colorectal cancer or colorectal dysplasia; 6. Prior use of any tumor necrosis factor (TNF) inhibitors (or any biologic agent); 7. Prior use of mycophenolic acid, tacrolimus, sirolimus, cyclosporine, or thalidomide; 8. Subjects who in the opinion of the Investigator may require treatment with chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) and / or aspirin during the study; 9. Use of budesonide-multimatrix (MMx) within the last 8 weeks; 10. Use of oral and/or IV corticosteroids within the last 2 weeks; 11. Use of immunosuppressants (azathioprene [AZA], 6-mercaptopurine [6-MP] or methotrexate [MTX]) within the last 8 weeks; 12. Use of coumadin, unfractionated or low molecular weight heparins or anticoagulant medications other than aspirin due to bleeding risk; 13. 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; 14. History of any of the following cardiac conditions within 6 months of screening: myocardial infarction, acute coronary syndrome, unstable angina, new onset atrial fibrillation, new onset atrial flutter, second- or third-degree atrioventricular block, ventricular fibrillation, ventricular tachycardia, heart failure, cardiac surgery, interventional cardiac catheterization (with or without a stent placement), interventional electrophysiology procedure, or presence of implanted defibrillator; 15. History of suicide attempt at any time in the subject’s lifetime prior to study start or major psychiatric illness requiring hospitalization within 3 years before study start; 16. 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; 17. Pregnant or breast feeding females; 18. 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; 19. Subjects with active hepatitis B, C and HIV infections; 20. History of congenital or acquired immunodeficiency (eg, Common Variable Immunodeficiency Disease); 21. History of malignancy, except for: • Treated (i.e., cured) basal cell or squamous cell in situ skin carcinomas; • Treated (i.e., cured) carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years; 22. Subjects who have received any investigational drug or device in the last 3 months; 23. History of alcohol, drug, or chemical abuse within the last 6 months; 24. Known hypersensitivity to niclosamide or any excipients in the formulation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of Niclosamide enemas 150 mg/60 ml and 450 mg/60 ml.;Secondary Objective: To evaluate the clinical efficacy of Niclosamide enemas 150 mg/60 ml and 450 mg/60 ml.;Primary end point(s): Primary Endpoints •Serious adverse reactions (i.e. treatment-related) during 6 weeks of treatment with Niclosamide enemas; •Grade = 3 adverse reactions during 6 weeks of treatment with Niclosamide enemas; •Grade = 2 adverse reactions during 6 weeks of treatment with Niclosamide enemas. Key secondary endpoint •Clinical remission defined as MMS = 2 with no individual subscore >1 after 6 weeks of treatment.;Timepoint(s) of evaluation of this end point: 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ND;Timepoint(s) of evaluation of this end point: ND | — |
Countries
Austria, Germany, Italy
Contacts
Public ContactAnita Falezza - Managing Director
Regulatory Pharma Net s.r.l.
Outcome results
None listed