VTX002 versus Placebo for the Treatment of Moderately toSeverely Active Ulcerative Colitis
- Conditions
- Health Condition 1: K519- Ulcerative colitis, unspecified
- Registration Number
- CTRI/2023/03/050181
- Lead Sponsor
- Oppilan Pharma Ltd a wholly owned subsidiary of Ventyx Biosciences Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
(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, TNFa 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
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 Crohn’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 ß-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) < 70% of predicted values and FEV1/FVC ratio < 0.70 at Screening
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 = 6 months prior
to or during the Screening Period.
b. Screening or pre-randomization vital signs taken in the sitting position with a HR < 50 bpm
OR systolic BP < 90 mmHg OR diastolic BP < 55 mmHg.
c. Screening or pre-randomization ECG with PR interval > 200 msec or Fridericia’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 = 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 (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
appropriate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br/ ><br>score (MMS)
- Secondary Outcome Measures
Name Time Method