Clinical Trials List
Protocol NumberCTJ301UC201
NCT Number(ClinicalTrials.gov Identfier)NCT03235752
2017-09-01 - 2020-01-31
Phase II
Recruiting2
ICD-10K51
Ulcerative colitis
ICD-9556.9
Ulcerative colitis, unspecified
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
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Trial Applicant
ComboTrial Consultancy Ltd .
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Sponsor
I-Mab Biopharma HongKong Limited
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Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Linkou Chang Gung Medical Foundation
Taiwan National PI
邱正堂
Co-Principal Investigator
- 許振銘 Digestive System Department
- Puo-Hsien Le Digestive System Department
- Wen-Sy Tsai Division of Colorectal Surgery
- 林蔚然 Digestive System Department
- Chia-Jung Kuo Digestive System Department
- Ming-Yao Su Digestive System Department
- Puo-Hsien Le Digestive System Department
The Actual Total Number of Participants Enrolled
2 Recruiting
Audit
None
Co-Principal Investigator
- 翁昭旼 Digestive System Department
- CHIEN-CHIH TUNG Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Ulcerative Colitis
Objectives
Primary Objective
To explorate the safety and efficacy of TJ301 in patients with active ulcerative colitis.
Secondary Objectives
To investigate the pharmacokinetics (PK) of TJ301 in patients with active ulcerative colitis.
To investigate the pharmacodynamics (PD) of TJ301 in patients with active ulcerative
colitis.
To investigate immunogenicity of TJ301 in patients with active ulcerative colitis.
Exploratory Objectives
To explorate the relationship between PKand PD of TJ301 in patients with active ulcerative
Test Drug
TJ301
Active Ingredient
Fusion protein consisting of two complete extracellular domains of gp130
Dosage Form
IV infusion
Dosage
15mg/mL
Endpoints
Primary Endpoints
Clinical and endoscopic remission at Week 12, defined as a full Mayo score ≤2, no
individual subscore >1, rectal bleeding subscore = 0.
Adverse events, vital signs, 12-lead Electrocardiography (ECG), and clinical safety
laboratory abnormalities.
Secondary Endpoints
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.
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.
Clinical response (decrease from Baseline in 9-point partial Mayo score ≥2 and ≥30%,
including decrease from Baseline in rectal bleeding subscore ≥1 or rectal bleeding subscore
≤1) at Weeks 4, 6, 8, 10, and 12.
Mucosal healing defined as Mayo endoscopic subscore = 0 or 1 at Week 12.
Change from Baseline to Weeks 4, 6, 8, 10, and 12 in 9-point partial Mayo score.
Change from Baseline to Week 12 in full Mayo score.
Change from Baseline to Week 12 in modified Mayo score (=full Mayo score excluding
Physician’s Global Assessment (PGA) subscore).
Change from Baseline to Weeks 4, 6, 8, 10, and 12 in PGA score.
FDA-defined remission at Week 12, defined as Stool frequency subscore=0, Rectal bleeding
subscore=0, and Endoscopy subscore =0 or 1.
Immunogenicity: Anti-TJ301 antibodies.
PK subgroup: AUCinf, AUCt
, %AUCext, Cmax, tmax, CL, Vz, λz, t½ , and MRT (if applicable).
Peak and trough (pre-infusion) TJ301 serum concentration.
Exploratory Endpoints
Change from Baseline to Weeks 4, 8, and 12 in exploratory biomarkers (erythrocyte
sedimentation rate [ESR], C-reactive protein (CRP), IL-6, IL-6/sIL-6R complex, neutrophil
and platelet count, faecal calprotectin).
Clinical and endoscopic remission at Week 12, defined as a full Mayo score ≤2, no
individual subscore >1, rectal bleeding subscore = 0.
Adverse events, vital signs, 12-lead Electrocardiography (ECG), and clinical safety
laboratory abnormalities.
Secondary Endpoints
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.
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.
Clinical response (decrease from Baseline in 9-point partial Mayo score ≥2 and ≥30%,
including decrease from Baseline in rectal bleeding subscore ≥1 or rectal bleeding subscore
≤1) at Weeks 4, 6, 8, 10, and 12.
Mucosal healing defined as Mayo endoscopic subscore = 0 or 1 at Week 12.
Change from Baseline to Weeks 4, 6, 8, 10, and 12 in 9-point partial Mayo score.
Change from Baseline to Week 12 in full Mayo score.
Change from Baseline to Week 12 in modified Mayo score (=full Mayo score excluding
Physician’s Global Assessment (PGA) subscore).
Change from Baseline to Weeks 4, 6, 8, 10, and 12 in PGA score.
FDA-defined remission at Week 12, defined as Stool frequency subscore=0, Rectal bleeding
subscore=0, and Endoscopy subscore =0 or 1.
Immunogenicity: Anti-TJ301 antibodies.
PK subgroup: AUCinf, AUCt
, %AUCext, Cmax, tmax, CL, Vz, λz, t½ , and MRT (if applicable).
Peak and trough (pre-infusion) TJ301 serum concentration.
Exploratory Endpoints
Change from Baseline to Weeks 4, 8, and 12 in exploratory biomarkers (erythrocyte
sedimentation rate [ESR], C-reactive protein (CRP), IL-6, IL-6/sIL-6R complex, neutrophil
and platelet count, faecal calprotectin).
Inclution Criteria
Inclusion Criteria
A subject will be eligible for inclusion in this study only if all of the following criteria apply:
1. Male and female patients 18-70 (inclusive) years of age.
2. Active UC confirmed by colonoscopy with biopsy or flexible sigmoidoscopy with biopsy at Screening, with extending > 15-cm past the anal verge from endoscopy.
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 (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 1.5 mg/kg/day or mercaptopurine (6-MP) at no less than 0.75 mg/kg/day
for at least 6 months and stable for at least 6 weeks prior to Randomization.
6. A female subject has been sterilized or has been menopausal, or the subject has no pregnancy
plan during the trial and voluntarily adopts effective contraceptive measures.
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.
A subject will be eligible for inclusion in this study only if all of the following criteria apply:
1. Male and female patients 18-70 (inclusive) years of age.
2. Active UC confirmed by colonoscopy with biopsy or flexible sigmoidoscopy with biopsy at Screening, with extending > 15-cm past the anal verge from endoscopy.
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 (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 1.5 mg/kg/day or mercaptopurine (6-MP) at no less than 0.75 mg/kg/day
for at least 6 months and stable for at least 6 weeks prior to Randomization.
6. A female subject has been sterilized or has been menopausal, or the subject has no pregnancy
plan during the trial and voluntarily adopts effective contraceptive measures.
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.
Exclusion Criteria
Exclusion Criteria
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
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.
7. Primary or secondary immunodeficiency including neutropenia (absolute neutrophil count
<1500/μL); or lymphopenia (absolute lymphocyte count <500/μL).
8. Moderate to severe anaemia (haemoglobin <9 g/dL), or thrombocytopenia (platelet count <75
000/μL), or serum creatinine >2 mg/dL.
9. Autoimmune disease besides UC, with the exceptions of Sjogren's syndrome or hypothyroidism.
10. Clostridium (C.) difficile positive at screening visit or treated for C. difficile within the 4
weeks prior to Randomization.
11. Known clinically relevant chronic liver disease. Impaired hepatic function in the absence of a
diagnosis of primary sclerosing cholangitis (serum transaminases >2.5 x upper limit of normal
[ULN], alkaline phosphatase >2.5 x ULN, or abnormalities in synthetic liver function tests
judged by the investigator to be clinically significant), or a diagnosis of primary sclerosing
cholangitis, serum transaminases >3 x ULN, alkaline phosphatase >3 x ULN, or abnormalities
in synthetic liver function tests (total bilirubin >1.5 x ULN) judged by the investigator to be
clinically significant.
12. Serious underlying disease other than UC in the opinion of the investigator.
13. History of drug addiction within the last 1 year or current drug addiction or use of illicit drugs.
14. Any indication of the regular use of more than 40 grams of alcohol every day.
15. Smokers who smoke more than 10 cigarettes per day.
16. Known concurrent acute or chronic viral hepatitis B or C infection or human
immunodeficiency virus (HIV) infection.
17. 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 positive T-spot test within 4 weeks of
Randomisation and evidence of current or previous pulmonary tuberculosis by chest X-ray
within 12 weeks of Randomisation.
18. Positive immunoglobulin M antibody titres in the presence of negative immunoglobulin G
titres to Epstein-Barr virus (EBV).
19. If clinical suspicion of cytomegalovirus (CMV), cytomegalovirus testing should be undertaken.
Subjects with intestinal mucosa biopsy positive for cytomegalovirus at screening are to be
excluded.
20. Receiving any investigational therapy or any approved therapy for investigational use within
30 days or 5 half-lives prior to Randomization (whichever is longer).
21. Currently taking any medications other than those allowed per protocol guidelines.
22. Infections (including diverticulitis) requiring treatment with antibiotics, antivirals, or
antifungals within 14 days prior to Randomisation.
23. Any prior use of biologic drugs.
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 (or equivalent) within 30 days prior to Randomisation.
26. Receipt of cyclosporine, tacrolimus, sirolimus, 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.
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
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.
7. Primary or secondary immunodeficiency including neutropenia (absolute neutrophil count
<1500/μL); or lymphopenia (absolute lymphocyte count <500/μL).
8. Moderate to severe anaemia (haemoglobin <9 g/dL), or thrombocytopenia (platelet count <75
000/μL), or serum creatinine >2 mg/dL.
9. Autoimmune disease besides UC, with the exceptions of Sjogren's syndrome or hypothyroidism.
10. Clostridium (C.) difficile positive at screening visit or treated for C. difficile within the 4
weeks prior to Randomization.
11. Known clinically relevant chronic liver disease. Impaired hepatic function in the absence of a
diagnosis of primary sclerosing cholangitis (serum transaminases >2.5 x upper limit of normal
[ULN], alkaline phosphatase >2.5 x ULN, or abnormalities in synthetic liver function tests
judged by the investigator to be clinically significant), or a diagnosis of primary sclerosing
cholangitis, serum transaminases >3 x ULN, alkaline phosphatase >3 x ULN, or abnormalities
in synthetic liver function tests (total bilirubin >1.5 x ULN) judged by the investigator to be
clinically significant.
12. Serious underlying disease other than UC in the opinion of the investigator.
13. History of drug addiction within the last 1 year or current drug addiction or use of illicit drugs.
14. Any indication of the regular use of more than 40 grams of alcohol every day.
15. Smokers who smoke more than 10 cigarettes per day.
16. Known concurrent acute or chronic viral hepatitis B or C infection or human
immunodeficiency virus (HIV) infection.
17. 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 positive T-spot test within 4 weeks of
Randomisation and evidence of current or previous pulmonary tuberculosis by chest X-ray
within 12 weeks of Randomisation.
18. Positive immunoglobulin M antibody titres in the presence of negative immunoglobulin G
titres to Epstein-Barr virus (EBV).
19. If clinical suspicion of cytomegalovirus (CMV), cytomegalovirus testing should be undertaken.
Subjects with intestinal mucosa biopsy positive for cytomegalovirus at screening are to be
excluded.
20. Receiving any investigational therapy or any approved therapy for investigational use within
30 days or 5 half-lives prior to Randomization (whichever is longer).
21. Currently taking any medications other than those allowed per protocol guidelines.
22. Infections (including diverticulitis) requiring treatment with antibiotics, antivirals, or
antifungals within 14 days prior to Randomisation.
23. Any prior use of biologic drugs.
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 (or equivalent) within 30 days prior to Randomisation.
26. Receipt of cyclosporine, tacrolimus, sirolimus, 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.
The Estimated Number of Participants
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Taiwan
20 participants
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Global
90 participants
