The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03235752




Registration number
NCT03235752
Ethics application status
Date submitted
28/07/2017
Date registered
1/08/2017
Date last updated
30/06/2020

Titles & IDs
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
Secondary ID [1] 0 0
CTJ301UC201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Active Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TJ301 300mg
Treatment: Drugs - TJ301 600mg
Treatment: Drugs - Placebo

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

Experimental: TJ301 600mg - TJ301 300mg administrations will occur on Days 0, 14, 28, 42, 56, and 70.

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


Treatment: Drugs: TJ301 300mg
TJ301 300mg IV infusion

Treatment: Drugs: TJ301 600mg
TJ301 600mg IV infusion

Treatment: Drugs: Placebo
Placebo IV infusion

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical and endoscopic remission at Week 12 - Clinical and endoscopic remission at Week 12, defined as a full Mayo score =2, no individual subscore >1, rectal bleeding subscore = 0.
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Clinical and endoscopic response - Clinical and endoscopic 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.
Timepoint [1] 0 0
Week 12.
Secondary outcome [2] 0 0
Clinical remission at Weeks 4, 6, 8, 10, and 12 - Clinical remission at Weeks 4, 6, 8, 10, and 12 defined as a stool frequency subscore=0, rectal bleeding subscore = 0, and 9-point partial Mayo score =1.
Timepoint [2] 0 0
Weeks 4, 6, 8, 10, and 12

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Linear clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing
Country [2] 0 0
China
State/province [2] 0 0
Chengdu
Country [3] 0 0
China
State/province [3] 0 0
Guangzhou
Country [4] 0 0
China
State/province [4] 0 0
Hainan
Country [5] 0 0
China
State/province [5] 0 0
Hangzhou
Country [6] 0 0
China
State/province [6] 0 0
Harbin
Country [7] 0 0
China
State/province [7] 0 0
Jilin
Country [8] 0 0
China
State/province [8] 0 0
Nanchang
Country [9] 0 0
China
State/province [9] 0 0
Nanjing
Country [10] 0 0
China
State/province [10] 0 0
Shanghai
Country [11] 0 0
China
State/province [11] 0 0
Shenyang
Country [12] 0 0
China
State/province [12] 0 0
Shijiazhuang
Country [13] 0 0
China
State/province [13] 0 0
Taiwan
Country [14] 0 0
China
State/province [14] 0 0
Taiyuan
Country [15] 0 0
China
State/province [15] 0 0
Tianjin
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Busan
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Daegu
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Seoul
Country [19] 0 0
Taiwan
State/province [19] 0 0
Kaohsiung
Country [20] 0 0
Taiwan
State/province [20] 0 0
Taipei
Country [21] 0 0
Taiwan
State/province [21] 0 0
Taoyuan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
I-Mab Biopharma HongKong Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a multicenter, randomized, double-blind, placebo-controlled phase II study.
Trial website
https://clinicaltrials.gov/show/NCT03235752
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Minhu Chen, Doctor
Address 0 0
First Affiliated Hospital, Sun Yat-Sen University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Yonghong Jia, Master
Address 0 0
Country 0 0
Phone 0 0
+8618513849471
Fax 0 0
Email 0 0
yonghong.jia@i-mabbiopharma.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03235752