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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03235752
Ethics application status
Date submitted
28/07/2017
Date registered
1/08/2017
Date last updated
5/01/2021

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:
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 endoscopy response
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Clinical and endoscopy remission at Week 12
Timepoint [1] 0 0
Week 12.
Secondary outcome [2] 0 0
Clinical remission at Weeks 4, 6, 8, 10, and 12
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. 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.
3. Active UC with a full Mayo score=5 and a rectal bleeding subscore =1 at screening.
4. During Day -28 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.
6. 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.
7. The patient is able and willing to comply with the requirements of this trial protocol.
8. The subject should be able to read and write to understand and fill out Patient Diary.
9. Voluntarily signed Informed Consent obtained before any trial-related procedures are performed.
10. 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
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. Subject who is likely to receive surgery for UC treatment within 1 month based on investigator's evaluation.
5. History of colostomy, colectomy or partial colectomy.
6. 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.
7. 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.
8. Primary or secondary immunodeficiency including neutropenia (absolute neutrophil count <1500/µL); or lymphopenia (absolute lymphocyte count <500/µL).
9. Moderate to severe anaemia (haemoglobin <9 g/dL), or thrombocytopenia (platelet count <75 000/µL), or serum creatinine >2 mg/dL.
10. Autoimmune disease besides UC, with the exceptions of Sjogren's syndrome or hypothyroidism.
11. Clostridium (C.) difficile positive at screening visit or treated for C. difficile within the 4 weeks prior to Randomization.
12. serum transaminases >2.5 x upper limit of normal [ULN], alkaline phosphatase >2.5 x ULN.
13. Serious underlying disease other than UC in the opinion of the investigator.
14. History of drug addiction within the last 1 year or current drug addiction or use of illicit drugs.
15. Any indication of the regular use of more than 40 grams of alcohol every day.
16. Smokers who smoke more than 10 cigarettes per day.
17. Known concurrent acute or chronic viral hepatitis B or C infection or human immunodeficiency virus (HIV) infection.
18. Presence or history of active tuberculosis (TB) or latent TB infection, defined as 1) a positive QuantiFERON-TB Gold test at Screening; or 2) a T-spot test within 4 weeks of Randomisation and evidence of current or previous pulmonary tuberculosis by low-dose CT or chest X-ray within 12 weeks of Randomisation. Patients with old TB will also be excluded.
19. Positive immunoglobulin M antibody titres to Epstein-Barr virus (EBV).
20. Subjects with positive results for cytomegalovirus at screening are to be excluded.
21. Receiving any investigational therapy or any approved therapy for investigational use within 30 days or 5 half-lives prior to Randomization (whichever is longer).
22. Currently taking any medications other than those allowed per protocol guidelines.
23. Infections (including diverticulitis) requiring treatment with antibiotics, antivirals, or antifungals within 14 days prior to Randomisation.
24. Received any live (attenuated) vaccines within 30 days prior to Randomisation.
25. Recent treatment with medium-to-high-dose intravenous corticosteroids (methylprednisolone 60 mg/day or hydrocortisone 300 mg/day) within 8 weeks prior to Randomisation or oral corticosteroids of more than 20 mg prednisone per day (or equivalent).
26. Receipt of cyclosporine, tacrolimus, sirolimus, thalidomide, or mycophenolate mofetil within 30 days prior to Randomisation.
27. Treatment with therapeutic enema or suppository, other than required for endoscopy preparation, within 14 days prior to the screening endoscopy and during the remainder of the trial.

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/12/2020
Sample size
Target
Accrual to date
Final
91
Recruitment in Australia
Recruitment state(s)
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
Taiyuan
Country [13] 0 0
China
State/province [13] 0 0
Tianjin
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Daegu
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seoul
Country [16] 0 0
Taiwan
State/province [16] 0 0
Kaohsiung
Country [17] 0 0
Taiwan
State/province [17] 0 0
Taipei
Country [18] 0 0
Taiwan
State/province [18] 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/study/NCT03235752
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

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