Safety and Efficacy of TJ301 IV in Participants With Active Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03235752
• Date of registration: 28/07/2017
• Prospective Registration: Yes
• Primary sponsor: I-Mab Biopharma HongKong Limited
• Public title: Safety and Efficacy of TJ301 IV in Participants With Active Ulcerative Colitis
• Scientific title: A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of TJ301 (FE 999301) Administered Intravenously in Patients With Active Ulcerative Colitis
• Date of first enrolment: February 6, 2018
• Target sample size: 90
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03235752
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Australia, China, Korea, Republic of, Taiwan

Contacts

• Name: Lijia Ma, Master

• Name: Minhu Chen, Doctor
• Affiliation: First Affiliated Hospital, Sun Yat-Sen University

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male and female patients 18-70 (inclusive) years of age.

2. History of active UC of more than 3 months. Active UC confirmed by colonoscopy with
biopsy or flexible sigmoidoscopy with biopsy at Screening, with extending > 15-cm past
the anal verge from endoscopy. Biopsy sample is not necessary if UC is already
confirmed.

3. Active UC with a full Mayo score=5 and a rectal bleeding subscore =1 at screening.

4. During Day -35 to Day -6 prior to Randomisation, an endoscopy subscore =2.

5. Treated with conventional non-biological UC therapy: with corticosteroids stable for
at least 2 weeks prior to Randomization at no more than 20 mg prednisone per day (or
equivalent), and/or with medications containing 5-aminosalicylates (5-ASA) at no less
than 2 g 5-ASA per day for at least 3 months and stable for at least 4 weeks prior to
Randomization, and/or with azathioprine (AZA) at no less than 0.75 mg/kg/day or
mercaptopurine (6-MP) at no less than 0.5 mg/kg/day for at least 6 months and stable
for at least 6 weeks prior to Randomization, or MTX no less than 12.5 mg/week and
stable for at least 12 weeks prior to Randomization.

Exclusion Criteria:

1. Pregnant or breastfeeding women.

2. Contraindication to colonoscopy or sigmoidoscopy.

3. Allergies to any component of TJ301.

4. History of colostomy, colectomy or partial colectomy.

5. Current diagnosis of inflammatory bowel disease unclassified, Crohn's disease,
ischemic colitis, fulminant colitis and/or toxic megacolon, patients with ulcerative
colitis limited to the rectum (ulcerative proctitis), infective enteritis, amebic
bowel disease and intestinal schistosomiasis.

6. History of malignancy other than a successfully treated non-metastatic cutaneous
squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the
cervix. If the Screening colonoscopy shows evidence of dysplasia or a malignancy, the
patient is not eligible.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Active Ulcerative Colitis

Intervention(s)

Drug: TJ301 600mg

Drug: TJ301 300mg

Drug: Placebo

Primary Outcome(s)

Clinical and endoscopic remission at Week 12 [Time Frame: Week 12]

Secondary Outcome(s)

Clinical and endoscopic response [Time Frame: Week 12.]

Clinical remission at Weeks 4, 6, 8, 10, and 12 [Time Frame: Weeks 4, 6, 8, 10, and 12]

Secondary ID(s)

CTJ301UC201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors