A Phase Ib Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of Single and Multiple Administration of AK101 in Subjects With Moderately to Severely Active Ulcerative Colitis

Akeso12 sites in 1 country34 target enrollmentNovember 26, 2020

ConditionsUlcerative Colitis

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Ulcerative Colitis
Sponsor: Akeso
Enrollment: 34
Locations: 12
Primary Endpoint: Mean residence time (MRT) of AK101
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase Ib clinical study to evaluate the safety, tolerance, pharmacokinetics and efficacy of AK101 in subjects with moderately to severely active ulcerative colitis.

Detailed Description

This is a phase Ib, randomized, double-blind, placebo-controlled, dose-escalation, two-phase study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of AK101 in subjects with moderately to severely active ulcerative colitis. The study consists of two parts. Part 1 is single-ascending-dose induction phase study, and Part 2 is a multiple subcutaneous maintenance therapy study followed by a single-dose induction treatment.

Registry

clinicaltrials.gov

Start Date

November 26, 2020

End Date

December 31, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Akeso

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Body mass index (BMI) ≥ 18 and ≤ 28 kg /m2 for male or female patients aged between 18 and 65 years (including upper and lower limits).
•Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months before screening, and the diagnosis of UC must be confirmed by endoscopic and histological evidence.
•Has moderately to severely active UC,defined as the adapted Mayo score (excluding PGA) of 5-9 (including upper and lower limits), Mayo endoscopic subscore ≥ 2 within 10 days before the first administrationof study drug and rectal bleeding subscore ≥
•Have evidence of ulcerative colitis extending proximal to the rectum (≥15 cm of involved colon).
•Demonstrated intolerance or inadequate response to conventional therapy and tofacitinib (not a biologic) and biologic therapies.
•For women with fertility, the serum pregnancy test must be negative during the screening period; Or women without fertility.If male and female subjects with sexual life and fertility voluntarily take contraceptive measures during the treatment and at least 6 months after the last Administration.

Exclusion Criteria

•Suspected or confirmed Crohn's disease (CD), undiagnosed type of colitis.
•Suffering from severe generalized colitis.
•Previous colectomy (total or subtotal resection) with ileal pouch, Kock pouch or ileostomy for ulcerative colitis.
•Patients who have received IL-12 / 23 or IL-23 target drug treatment.
•Received Natalizumab or other drugs that regulate B cells or T cells within 12 months before randomization, such as Rituximab, Alemtuzumab, Abatacept treatment.
•Received infliximab and adalimumab 2 months before randomization, and received Vedolizumab and other biological treatments 3 months before randomization.
•Patients with active hepatitis B virus (HBV) infection or active hepatitis C virus (HCV).
•Suffering from human immunodeficiency virus (HIV) or syphilis.
•Active tuberculosis or Latent tuberculosis infection.
•Has a history of, or ongoing, chronic or recurrent infectious disease.,