A Study to Evaluate the Efficacy and Safety of ZYIL1 Oral Capsules for the Treatment of Patients … (NCT06398808) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Efficacy and Safety of ZYIL1 Oral Capsules for the Treatment of Patients With Mild to Moderately Active Ulcerative Colitis Resistant or Intolerant to Oral Aminosalicylates
India24 participantsStarted 2024-04-08
Plain-language summary
The purpose of this study is to evaluate efficacy and safety of ZYIL1 oral capsule twice a day for 12 weeks for treatment of mild to moderate active ulcerative colitis resistant or intolerant to oral aminosalicylates.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male and female patients aged 18 to 75 years, both inclusive.
✓. Have had ulcerative colitis (UC) diagnosed at least 3 months prior to screening. The diagnosis of UC must be confirmed by endoscopic and histologic evidence.
✓. Mild to Moderate active disease defined as total score of at least 4 on the mMS, endoscopy subscore of at least 2 and a rectal bleeding sub-score of at least 1.
✓. Demonstrated an inadequate response to, loss of response to, or intolerance to any of the Oral aminosalicylates (e.g., mesalamine, sulfasalazine, olsalazine, balsalazide)
✓. Have undergone colonoscopy within the past 2 years for extent of disease, and if the UC has been present for \> 10 years, have had a colonoscopy with biopsy to rule out dysplasia
✓. Patients who meet following laboratory values (assessed within 28 days prior to randomization):
✓. WBCs ≥2000/μL
✓. Neutrophils ≥1500/μL
Exclusion criteria
✕. Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease.
✕. Have severe extensive colitis as evidenced by at least one of the following:
✕. Physician judgment that the patient is likely to require colectomy or ileostomy within 12 weeks of baseline.
What they're measuring
1
To assess the efficacy of ZYIL1 for induction of clinical remission
. Current evidence of fulminant colitis, toxic megacolon or bowel perforation.
✕. Previous total colectomy
✕. Have 4 or more of the following i.e Body temperature \> 38 C,HR \> 110 (bpm),Focal severe or rebound abdominal tenderness,Anemia (hemoglobin \[Hgb\] \< 8.5 g/dL), Transverse colon diameter \> 5 cm on plain X-ray.
✕. Have positive stool culture for pathogens (O P, bacteria) or positive test for C.
✕. Patients who have an evidence of pathogenic bowel infection.