Health Condition 1: K519- Ulcerative colitis, unspecified
Conditions
Interventions
Intervention1: VTX002- 30mg: VTX002 30 mg, once daily, for the first 13 weeks of double-blind treatment. Followed by 39 weeks long term extension phase.
Intervention2: VTX002- 60mg: VTX002 60 mg, once
Sponsors
Oppilan Pharma Ltd a wholly owned subsidiary of Ventyx Biosciences Inc
Eligibility
Inclusion criteria
Inclusion criteria: (1) Diagnosed with UC >= 3 months prior to Screening. The diagnosis of UC must be confirmed by endoscopic and histologic evidence. (2) Active UC confirmed by endoscopy with >= 10 cm rectal involvement. Moderately to severely active UC, defined as an MMS of 5 to 9, including an ES >= 2 and an RB subscore >= 1 (3) Surveillance colonoscopy within 12 months before baseline or at screening to rule out dysplasia, pancolitis, left-sided colitis. Any adenomatous polyps must be removed prior to the first dose of study drug. (4) Demonstrated inadequate response to, loss of response to, or intolerance to at least 1 of the following therapies: Conventional therapy, Oral 5-ASA compounds, Corticosteroids, Thiopurines, Biologic therapy/ JAK inhibitor therapy, TNFα antibodies, Anti-interleukin (anti-IL)12/23, Anti-integrin antibodies, (5) Adequate hepatic function (6) Adequate renal function, with estimated glomerular filtration rate >= 60 mL/min/1.73 m2 at Screening (7) Patients are permitted to receive the following concomitant medications: a.Oral 5-ASA compounds at a stable dose or discontinued for >= 2 weeks prior to Screening endoscopy b.Oral corticosteroid therapy at a stable dose or discontinued for >= 2 weeks prior to Screening endoscopy c.Probiotics, provided the dose has been stable for >= 2 weeks prior to Screening endoscopy
Exclusion criteria
Exclusion criteria: 1. Severe extensive colitis as evidenced by: a. Physician judgment that the patient is likely to require surgical intervention of any kind for UC within 12 weeks of baseline. b. Current evidence of fulminant colitis or toxic megacolon, or recent history of toxic megacolon or bowel perforation c. Previous total colectomy 2. Diagnosis of Crohnâ??s disease or indeterminate colitis. 3. Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis 4. Positive assay or stool culture for pathogens or positive test for Clostridium difficile toxin at Screening. 5. Pregnancy, lactation, or a positive serum β-hCG measured during Screening 6. Clinically relevant hematologic, hepatic, neurological, pulmonary, ophthalmological, endocrine, metabolic, psychiatric, or other major systemic disease that will make implementation of the protocol or interpretation of the study difficult or will put the patient at risk 7. Forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) 8. Have any of the following conditions or receiving treatments that may affect cardiovascular function: a. Myocardial infarction, unstable angina, stroke/transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III/IV heart failure within to or during the Screening Period. b. Screening or pre-randomization vital signs taken in the sitting position with a HR OR systolic BP c. Screening or pre-randomization ECG with PR interval > 200 msec or Fridericiaâ??s corrected QT interval (QTcF) >= 450 msec in men or >= 470 msec in women d. History of any of the following unless treated with an implanted pacemaker or animplanted cardioverter-defibrillator with pacing: i. History or presence of recurrent symptomatic bradycardia ii. Second- or third-degree AV 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 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 (HbA1c) > 9%, or patients 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 or precancerous conditions such as colonic mucosal dysplasia, cervical dysplasia, and cervical intraepithelial neoplasia 12. History of lymphoproliferative disorder, lymphoma, leukemia, myeloproliferative disorder, or multiple myeloma 13. History of alcohol or drug abuse within 1 year prior to randomization 14 . Active or latent TB infection at Screening. History of untreated or inadequately treated latent TB infection. The following are EXCEPTIONS to this exclusion criterion: a. Patients with latent TB, who have been ruled out for active TB, have completed an <br/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical remission at 13 weeks [ Time Frame: Day 1 of Induction treatment period to week 13 ]Timepoint: The proportion of participants with clinical remission at Week 13 using modified Mayo score (MMS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess the efficacy of VTX002 when administered for 13 weeks on endoscopic changes, symptomatic response and remission, histology, and mucosal healingTimepoint: Endoscopy will be performed at week 13 to complete the assessment;Assess the safety of VTX002 after daily doses for 13 weeksTimepoint: The proportion of participants with symptomatic remission at Week 13 The proportion of participants with histologic remission at Week 13 The proportion of participants with mucosal healing at Week 13;Assess the efficacy of VTX002 through the Long-Term Extension (LTE) and Open-Label Extension (OLE) Treatment Periods on endoscopic changes, symptomatic response and remission, histology, and mucosal healingTimepoint: Proportion of participants with clinical remission after 52 weeks of treatment Proportion of participants with symptomatic remission at Weeks 18, 26, 36, and 52 Proportion of participants with mucosal healing after 52 weeks of treatment Proportion of participants with clinical response after 52 weeks of treatment Proportion of participants with symptomatic response at Weeks 18, 26, 36, and 52;Assess the effect of VTX002 on health-related quality of life (HRQoL) outcomes and biomarkersTimepoint: Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score at Weeks 13 and 52 | — |
Countries
Australia, Belarus, Bulgaria, Czech Republic, France, Georgia, Germany, Greece, Hungary, India, Israel, Italy, Lithuania, New Zealand, Poland, Republic of Korea, Russian Federation, Serbia, Slovakia, Spain, Sweden, Ukraine, United States of America
Contacts
Public ContactDr Radhika Bobba
PSI CRO pharma India Pvt Ltd
Outcome results
None listed