Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
Conditions
Interventions
Product Code: VTX002
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: not yet available
Current Sponsor code: VTX002
Other descriptive name: VTX002 is not biologic
Concentration unit: mg m
Sponsors
Oppilan Pharma Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women, 18 to 80 years of age, inclusive, at the time of consent. 2. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form. 3. 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 the source documents; however, if not available, the Screening endoscopy and histology may serve as such. 4. Active UC confirmed by endoscopy with = 10 cm rectal involvement. Subjects with proctitis only at baseline who meet the other eligibility criteria for inclusion, including the endoscopic and rectal bleeding criteria for moderate to severe disease, will be capped at 10% of the total subjects enrolled. 5. Moderately to severely active UC, defined as an MMS of 4 to 9, including an endoscopic subscore (ES) = 2 and a rectal bleeding (RB) subscore = 1. 6. Surveillance colonoscopy (performed according to local standard) within 12 months before baseline to rule out dysplasia in subjects with pancolitis > 8 years duration or subjects with left sided colitis > 12 years duration. Subjects without a surveillance colonoscopy within the prior 12 months will have a colonoscopy at Screening (ie, in place of Screening proctosigmoidoscopy). Any adenomatous polyps must be removed per local standard of care prior to the first dose of study drug. 7. Demonstrated inadequate response to, loss of response to, or intolerance to at least 1 of the following therapies: a. Conventional therapy: i. Oral 5-aminosalicylic acid (5 ASA) compounds ii. Corticosteroids iii. Thiopurines (eg, azathioprine or 6 mercaptopurine) b. Biologic therapy or JAK inhibitor therapy: i. Anti-tumor necrosis factor alpha (TNFa) antibodies (eg, infliximab, adalimumab, or golimumab) ii. Anti interleukin (anti-IL)12/23 (eg, ustekinumab) iii. Anti integrin antibodies (eg, vedolizumab) iv. JAK inhibitors (eg, tofacitinib) Inclusion criteria No.: 8 - 11 can be found in study protocol. 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 167 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 13
Exclusion criteria
Exclusion criteria: 1. Severe extensive colitis as evidenced by: a. Physician judgment that the subject is likely to require surgery (surgical intervention of any kind for UC [eg, colectomy]) within 12 weeks of baseline. b. Current evidence of fulminant colitis or toxic megacolon, or recent history (within last 6 months) of toxic megacolon or bowel perforation. c. Previous total or partial colectomy. 2. Diagnosis of Crohn’s disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn’s disease. 3. Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis. 4. Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridium difficile toxin at Screening. Note: If C. difficile test is positive, the subject may be treated for C. difficile and retested = 4 weeks after completing C. difficile treatment. 5. Pregnancy, lactation, or a positive serum ß hCG measured during Screening. 6. Clinically relevant hematologic, hepatic, neurological, pulmonary, ophthalmological, endocrine, metabolic (including, but not limited to, hypo- and hyperkalemia), psychiatric, or other major systemic disease that will make implementation of the protocol or interpretation of the study difficult or will put the subject at risk. 7. Forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) 200 msec or Fridericia’s corrected QT interval = 450 msec in men or = 470 msec in women d. History of any of the following unless treated with an implanted pacemaker or an implanted cardioverter defibrillator with pacing: i. History or presence of recurrent symptomatic bradycardia ii. Second or third degree atrioventricular block iii. Periods of asystole > 3 seconds iv. History of sick sinus syndrome or recurrent cardiogenic syncope e. Start, stop, or change in dosage of any Class I-IV anti-arrhythmic drugs = 1 week prior to dose titration starting at randomization and up to 1 week after titration to the assigned dose. This criterion also applies to the OLE Treatment Period titration: 1 week prior to and 1 week after the dose titration period. 9. Uncontrolled diabetes as determined by hemoglobin A1c > 9%, or subjects with diabetes with significant comorbid conditions, such as retinopathy. 10. History or presence of macular edema or retinopathy. 11. History of cancer within the last 5 years, including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved) or precancerous conditions such as colonic mucosal dysplasia, cervical dysplasia, and cervical intraepithelial neoplasia. 12. History of lymphoproliferative disorder, lymphoma, leukemia, myeloproli
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the efficacy of VTX002 when administered for 13 weeks on clinical remission.;Secondary Objective: • Assess the efficacy of VTX002 when administered for 13 weeks on endoscopic changes, symptomatic response and remission, histology, and mucosal healing • Assess the safety of VTX002 after daily doses for 13 weeks • Assess the pharmacokinetics (PK) of VTX002 Open-Label Extension Objectives: • Assess the efficacy of VTX002 through the OLE Treatment Period on endoscopic changes, symptomatic response and remission, histology, and mucosal healing • Assess the safety of VTX002 through the OLE Treatment Period;Primary end point(s): The proportion of subjects with clinical remission at Week 13 using modified Mayo score (MMS).;Timepoint(s) of evaluation of this end point: Week 13 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The proportion of subjects with endoscopic improvement at Week 13. The proportion of subjects with symptomatic remission at Week 13. The proportion of subjects with histologic remission at Week 13. The proportion of subjects with mucosal healing at Week 13. ;Timepoint(s) of evaluation of this end point: Week 13 | — |
Countries
Belarus, Belgium, Bulgaria, Czechia, Czech Republic, France, Georgia, Germany, Hungary, Israel, Italy, Lithuania, Poland, Russian Federation, Slovakia, Ukraine, United States
Contacts
Public ContactClinical Trial Information
Oppilan Pharma Ltd.
Outcome results
None listed