Study to Evaluate the Clinical Activity and Safety of Oral NX-13 in Participants with Moderate to Severe Ulcerative Colitis
- Conditions
- lcerative ColitisMedDRA version: 20.1Level: LLTClassification code: 10045365Term: Ulcerative colitis Class: 10017947Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- CTIS2022-503005-38-00
- Lead Sponsor
- andos Biopharma Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 97
18 to 75 years of age at time of informed consent, Women of childbearing potential (WOCBP) must: • Agree to use birth control methods that are considered highly effective: o Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal oProgestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable o Intrauterine device (IUD) o Intrauterine hormone-releasing system (IUS) o Bilateral tubal occlusion oVasectomized partner o Sexual abstinence Note: Contraceptive measures such as Plan B (used after unprotected sex) are not considered highly effective methods of contraception for this study • Agree not to participate in a conception process (i.e., active attempt to become pregnant, egg donation, in vitro fertilization) for at least 30 days after the last dose of investigational product, Able to give informed consent, attend, and comply with study visits and e-diaries, Diagnosed with UC = 3 months prior to screening. The diagnosis of UC must be confirmed by endoscopic and histologic evidence. The endoscopy and histology report should be present in source documents; however, if not available, the screening endoscopy and histology report may serve as such., Received a surveillance colonoscopy (performed according to local standard) within 12 months prior to the planned randomization date to rule out dysplasia in individuals with pancolitis > 8 years duration or individuals with left sided colitis > 12 years duration. Individuals without a surveillance colonoscopy within the prior 12 months will have a colonoscopy at screening (i.e., in place of the screening proctosigmoidoscopy). Any adenomatous polyps must be removed according to routine practice prior to the study participant’s first dose of investigational product., Moderate to severe disease activity, characterized by all of the following (see Section 7.3.1 for details): •MMS = 5 defined as follows: •ES = 2 within 14 days prior to randomization •RBS = 1, An inadequate response to, loss of response to, or intolerance of at least 1 of the following therapies, as defined below (see Section 12.9 for details): Conventional therapy classes: •Oral 5-ASA compounds plus systemic glucocorticosteroids/glucocorticoids •Systemic glucocorticosteroids/glucocorticoids •Thiopurines Biologic therapy classes: •Anti-TNF monoclonal antibodies or biosimilars •Anti-integrin monoclonal antibodies •Anti-IL-12/23 monoclonal antibodies Advanced therapy classes: •JAK inhibitors •S1P receptor modulators, Eligible male participants must either: • Be surgically sterile (i.e., vasectomy) for = 3 months (= 90 days) before screening; or • Agree to the following, from the time of randomization until at least 30 days after last dose of investigational product: o Agree to use a condom with spermicide when sexually active with a female partner who was not using a highly effective method of birth control o Agree not to participate in a conception process (i.e., active attempt to impregnate, sperm donation, or in vitro fertilization), Eligible female participants must be: • Nonpregnant, evidenced by a urine dipstick pregnancy test within 24 hours prior to randomization, and • Nonlactating, Eligible female participants of non-childbearing potential must be surgically sterile or postmenopausal (defined as = 1 year without menses). • Women must be surgically sterile for at least
Severe extensive colitis as evidenced by: • Physician judgment that the participant is likely to require hospitalization for medical care or surgical intervention of any kind for UC (e.g., colectomy) within the 12 weeks after randomization • Current evidence of fulminant colitis, toxic megacolon or recent history (within 6 months prior to screening) of toxic megacolon, or bowel perforation, Hospitalization for exacerbation of UC requiring IV steroids (i.e., UC flare) within 12 weeks prior to screening (a single dose of IV steroids is acceptable), Treatment with cyclosporine, tacrolimus, sirolimus, methotrexate, or mycophenolate mofetil within 4 weeks prior to screening., Thiopurine washout is required to be completed within 6 weeks prior to screening., Treatment with a biologic agent (e.g., infliximab, vedolizumab) within 6 weeks or 5 elimination half-lives (whichever is less) prior to screening. For anti-IL-12/23 (p19 or p40 subunits) (e.g., ustekinumab) a total of 12 weeks (6 weeks prior to screening and 6 weeks of screening) or 5 elimination half-lives (whichever is less) of washout., Treatment with an advanced oral UC therapy (e.g., JAK inhibitor, S1P modulator) within 4 weeks prior to screening, Treatment with IV glucocorticosteroids/glucocorticoids, rectal glucocorticosteroids/ glucocorticoids, rectal or topical 5-ASA, or enema within 2 weeks prior to screening, Treatment with oral prednisone at a daily dose of > 20 mg (or equivalent) or active oral glucocorticosteroids/ glucocorticoids , e.g., budesonide at a daily dose of > 9 mg or equivalent, within 30 days prior to screening. If receiving systemically active oral glucocorticosteroids/ glucocorticoids , must be on a stable dose for at least 14 days prior to screening., Confirmed or suspected infection of the intestinal tract, including positive Clostridioides difficile stool test at screening, Have acute or chronic hepatitis B infection or test positive for hepatitis B virus (HBV) at screening, Have current hepatitis C infection or test positive for hepatitis C virus (HCV) at screening, Diagnosis of Crohn’s disease (CD) or indeterminate colitis, or the presence or history of a fistula consistent with CD, Have known infection with human immunodeficiency virus as confirmed by medical history, Live virus vaccination within 4 weeks prior to randomization (Note: no currently available vaccine for SARS-CoV-2 is a live virus vaccine), Fecal microbial transplantation within 30 days prior to screening, Known primary or secondary immunodeficiency, Previously received stem cell transplantation, Has been a previous recipient of an organ transplant, which requires continued immunosuppression, Any surgical procedure requiring general anesthesia within 4 weeks prior to randomization, or planned elective surgery during the study, History of malignant neoplasms or carcinoma within 5 years prior to screening (except basal cell and in situ squamous cell carcinomas of the skin that have been fully excised and resolved), Requirement for regular dosing of strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin) or inducers (e.g., rifampin, phenytoin, carbamazepine) or CYP2C19 inhibitors (e.g., fluconazole, fluoxetine, fluvoxamine, ticlopidine) or inducers (e.g., rifampin)., Current or recent history of alcohol dependence or recreational drug use that, in the opinion of the investigator, may interfere with the individual’s ability to comply with the study procedures, Inadequate res
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method