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

NCT03235752 | Completed Phase 2 DMC

• 1 other identifier: CTJ301UC201
• Study Type: interventional
• Target: 91
• Locations: 3 countries
• Sites: 27

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled phase II study.

Conditions

Active Ulcerative Colitis

Keywords

Randomized; Double-blind; Placebo-controlled; Safety; Efficacy; Active Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Clinical and endoscopy response

  Clinical and endoscopy response (decrease from Baseline in full Mayo score ≥3 and ≥30%, including decrease from Baseline in rectal bleeding subscore ≥1 or rectal bleeding subscore ≤1) at Week 12.

  Week 12

Secondary Outcomes (2)

• Clinical and endoscopy remission at Week 12

  Week 12.

• Clinical remission at Weeks 4, 6, 8, 10, and 12

  Weeks 4, 6, 8, 10, and 12

Other Outcomes (1)

• Change from Baseline to Weeks 4, 8, and 12 in exploratory biomarkers

  Baseline to Weeks 4, 8, and 12

Study Arms (3)

TJ301 300mg

EXPERIMENTAL

TJ301 300mg administrations will occur on Days 0, 14, 28, 42, 56, and 70.

Drug: TJ301 300mg

TJ301 600mg

EXPERIMENTAL

TJ301 300mg administrations will occur on Days 0, 14, 28, 42, 56, and 70.

Drug: TJ301 600mg

Placebo

PLACEBO COMPARATOR

Placebo administrations will occur on Days 0, 14, 28, 42, 56, and 70.

Drug: Placebo

Interventions

TJ301 300mg DRUG

TJ301 300mg IV infusion

TJ301 300mg

TJ301 600mg DRUG

TJ301 600mg IV infusion

TJ301 600mg

Placebo DRUG

Placebo IV infusion

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients 18-70 (inclusive) years of age.
• Hisory 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.
• Active UC with a full Mayo score≥5 and a rectal bleeding subscore ≥1 at screening.
• During Day -28 to Day -6 prior to Randomisation, an endoscopy subscore ≥2.
• 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.
• Male subjects and female subjects of child bearing potential must have been willing to practice effective contraception during the study and been willing and able to continue contraception for 1 month after their last dose of the study treatment.
• The patient is able and willing to comply with the requirements of this trial protocol.
• The subject should be able to read and write to understand and fill out Patient Diary.
• Voluntarily signed Informed Consent obtained before any trial-related procedures are performed.
• The subject have not received any biologic therapies OR have received 1 biologic drug for the treatment of UC or immune diseases and the last dose must be longer than 8-week or a 5 half-life (whichever is longer) period prior to the first dose of study drug.

You may not qualify if:

• Pregnant or breastfeeding women.
• Contraindication to colonoscopy or sigmoidoscopy.
• Allergies to any component of TJ301.
• Subject who is likely to receive surgery for UC treatment within 1 month based on investigator's evaluation.
• History of colostomy, colectomy or partial colectomy.
• 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 or intestinal schistosomiasis.
• 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.
• Primary or secondary immunodeficiency including neutropenia (absolute neutrophil count \<1500/μL); or lymphopenia (absolute lymphocyte count \<500/μL).
• Moderate to severe anaemia (haemoglobin \<9 g/dL), or thrombocytopenia (platelet count \<75 000/μL), or serum creatinine \>2 mg/dL.
• Autoimmune disease besides UC, with the exceptions of Sjogren's syndrome or hypothyroidism.
• Clostridium (C.) difficile positive at screening visit or treated for C. difficile within the 4 weeks prior to Randomization.
• serum transaminases \>2.5 x upper limit of normal \[ULN\], alkaline phosphatase \>2.5 x ULN.
• Serious underlying disease other than UC in the opinion of the investigator.
• History of drug addiction within the last 1 year or current drug addiction or use of illicit drugs.
• Any indication of the regular use of more than 40 grams of alcohol every day.

Sponsors & Collaborators

• I-Mab Biopharma HongKong Limited: lead

Study Sites (27)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Beijing Friendship Hospital Affiliated to the Capital University of Medical Sciences

Beijing, Beijing Municipality, China

Location

The Seventh Medical Center of PLA Army General Hospital

Beijing, Beijing Municipality, China

Location

West China Hospital of Sichuan University

Sichuan, Chengdu, 610000, China

Location

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangzhou, 510655, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangzhou, China

Location

Nanfang Hospital of SMU

Guangzhou, Guangzhou, China

Location

The First Affiliated Hospital, Sun Yat-sen University

Guanzhou, Guangzhou, 510080, China

Location

Hainan General Hospital

Hainan, Hainan, China

Location

Sir Run Run Shaw Hospital Zhejiang University, School of Medicine

Zhejiang, Hangzhou, China

Location

The First Affiliated Hospital of Harbin Medical University

Harbin, Harbin, China

Location

The first Bethune hospital of Jilin university

Jilin, Jilin, China

Location

The first affiliated hospital of Nanchang Univesity

Nanchang, Nanchang, China

Location

Jiangsu Province Hospital

Nanjing, Nanjing, China

Location

The Affiliated Hospital of Nanjing University Medical School

Nanjing, Nanjing, China

Location

Zhongda Hospital Southeast University

Nanjing, Nanjing, China

Location

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

Xin Hua Hospital affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

Shengjing hospital of China medical university

Shenyang, Shenyang, China

Location

Second Hospital of Shanxi Medical University

Shanxi, Taiyuan, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Location

Yeungnam University Medical Center

Daegu, South Korea

Location

CHA Bundang Medical Center, CHA University

Seoul, South Korea

Location

National Taiwan University Hospital

Kaohsiung City, Taiwan

Location

Chang Gung Memorial Hospital

Taipei, Taiwan

Location

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

Related Publications (1)

• Zhang S, Chen B, Wang B, Chen H, Li Y, Cao Q, Zhong J, Shieh MJ, Ran Z, Tang T, Yang M, Xu B, Wang Q, Liu Y, Ma L, Wang X, Zhang N, Zhang S, Guo W, Huang L, Schreiber S, Chen M. Effect of Induction Therapy With Olamkicept vs Placebo on Clinical Response in Patients With Active Ulcerative Colitis: A Randomized Clinical Trial. JAMA. 2023 Mar 7;329(9):725-734. doi: 10.1001/jama.2023.1084.

  PMID: 36881032 DERIVED

Study Officials

• Minhu Chen, Doctor

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomized, Double-blind, Placebo-controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-blind, Placebo-controlled

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: August 1, 2017
• Study Start: February 6, 2018
• Primary Completion: December 21, 2020
• Study Completion: December 21, 2020
• Last Updated: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (22); KR (2); TW (3)