Ulcerative Colitis
Conditions
Brief summary
The purpose of the study is to evaluate the safety, efficacy, and pharmacokinetics of AC-101 tablets in participants with moderate-to-severe ulcerative colitis. The total study duration is up to 17 weeks, including 4-week screening, 12-week treatment period, and 1-week safety follow-up. The study will enroll approximately 24 participants with moderate to severe active ulcerative colitis.
Interventions
DRUGAC-101
AC-101 tablets will be administered orally.
Sponsors
Accro Bioscience (Suzhou) Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Ulcerative Colitis (UC) or suspected UC symptom for at least 3 months prior to enrolment and confirmed diagnosis of UC by endoscopic and histopathological examinations during screening. * Evidence of active UC defined by modified Mayo score of 5 to 9 points (inclusive) with 3 subscores meeting the followings: 1. Stool frequency (SF) subscore of .≥ 2 points, and 2. Rectal bleeding (RB) subscore of .≥ 1 points, and 3. Endoscopic (ES) subscore of ≥ 2 points (excluding friability), confirmed by screening endoscopy * Disease extension of ≥ 15cm from anal verge, confirmed by screening endoscopy * Currently using concomitant 5-salicylates (5-ASA) or oral corticosteroid (≤ 20 mg prednisone or equivalent, ≤ 9 mg budesonide MMX or equivalent) should keep stable doses from 2 weeks prior to enrolment till study completion. * Biologic-naïve or previous biological treatment for more than 5 half-lives.
Exclusion criteria
* Previous/current documented diagnosis of Crohn's Disease (CD), indeterminate colitis, severe UC required hospitalization or corticosteroid pulse therapy, ulcerative proctitis, fulminant colitis, ischemic colitis and other intestinal diseases. * Previous received 2 or more types of advanced treatment including biologics (e.g., TNF-α antibodies, IL-12/23 antibodies, integrin-α4β7 antibodies) and small molecule (e.g., JAK inhibitors, S1P receptor modulator), and all deemed by investigator as treatment failure. * Intravenous/rectal administration of steroids or topical administration of 5-ASA within 2 weeks prior to enrolment; systemic administration of small molecule (e.g., Tofacitinib, Upadacitinib, Ozanimod) within 4 weeks prior to enrolment. * Clostridium difficile infection or other enteric pathogen infection within 30 days prior to endoscopy, or positive for Clostridium difficile or other enteric pathogens prior to enrolment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and Severity of Adverse Events | Up to Week 13 | An Adverse Event (AE) is defined as any new untoward medical condition or worsening of a pre-existing medical condition following or during exposure to an investigation product, whether or not considered causally related to the product. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieved Clinical Response | Week 12 | Clinical response is defined as achieving the following changes in the modified Mayo score (excludes the physicians' global assessment) 1. A decrease from baseline in modified Mayo score of ≥ 2 points, and 2. A decrease from baseline in modified Mayo score of ≥ 30%, and 3. A decrease from baseline in rectal bleeding (RB) subscore of ≥ 1 point or absolute RB subscore ≤ 1 point The modified Mayo score is a sum of the following 3 subscores: 1. Stool frequency (SF) subscore (0-3) 2. Rectal bleeding (RB) subscore (0-3) 3. Endoscopic (ES) subscore (0-3) |
| Proportion of Participants achieved Clinical Remission | Week 12 | Clinical remission is defined as achieving the following changes in the modified Mayo score 1. Absolute modified Mayo score ≤ 2 points, and 2. Absolute SF subscore ≤ 1 point, and 3. Absolute RB subscore = 0 point, and 4. Absolute ES subscore ≤ 1 point |
Countries
China
Outcome results
None listed