Active Ulcerative ColitisPhase 2NCT03235752
Safety and Efficacy of TJ301 IV in Participants With Active Ulcerative Colitis
A Phase 2 study testing TJ301 300mg and TJ301 600mg in people with Active Ulcerative Colitis, run by I-Mab Biopharma HongKong Limited at 27 sites in 3 countries.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled phase II study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Active Ulcerative Colitis
- What is being tested?
- TJ301 300mg and TJ301 600mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 27 sitesin 3 countries
- Study dates
- 6 Feb 2018to 21 Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Smokers who smoke more than 10 cigarettes per day.
- Known concurrent acute or chronic viral hepatitis B or C infection or human immunodeficiency virus (HIV) infection.
- 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.
- Positive immunoglobulin M antibody titres to Epstein-Barr virus (EBV).
- Subjects with positive results for cytomegalovirus at screening are to be excluded.
- Receiving any investigational therapy or any approved therapy for investigational use within 30 days or 5 half-lives prior to Randomization (whichever is longer).
- Currently taking any medications other than those allowed per protocol guidelines.
- Infections (including diverticulitis) requiring treatment with antibiotics, antivirals, or antifungals within 14 days prior to Randomisation.
- Received any live (attenuated) vaccines within 30 days prior to Randomisation.
- 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).
- Receipt of cyclosporine, tacrolimus, sirolimus, thalidomide, or mycophenolate mofetil within 30 days prior to Randomisation.
- 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.
Trial locations and contacts
27 sites in 3 countries.
27 sites in 3 countries
China22 sites
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Beijing Friendship Hospital Affiliated to the Capital University of Medical Sciences
Beijing, Beijing Municipality
The Seventh Medical Center of PLA Army General Hospital
Beijing, Beijing Municipality
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangzhou, 510655
Guangdong Provincial People's Hospital
Guangzhou, Guangzhou
Nanfang Hospital of SMU
Guangzhou, Guangzhou
The First Affiliated Hospital, Sun Yat-sen University
Guanzhou, Guangzhou, 510080
Hainan General Hospital
Hainan, Hainan
The First Affiliated Hospital of Harbin Medical University
Harbin, Harbin
The first Bethune hospital of Jilin university
Jilin City, Jilin
The first affiliated hospital of Nanchang Univesity
Nanchang, Nanchang
Jiangsu Province Hospital
Nanjing, Nanjing
The Affiliated Hospital of Nanjing University Medical School
Nanjing, Nanjing
Zhongda Hospital Southeast University
Nanjing, Nanjing
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Xin Hua Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Second Hospital of Shanxi Medical University
Shanxi, Taiyuan
Shengjing hospital of China medical university
Shenyang, Shenyang
West China Hospital of Sichuan University
Sichuan, Chengdu, 610000
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
Sir Run Run Shaw Hospital Zhejiang University, School of Medicine
Zhejiang, Hangzhou
Taiwan3 sites
National Taiwan University Hospital
Kaohsiung City
Chang Gung Memorial Hospital
Taipei
Chang Gung Memorial Hospital
Taoyuan
South Korea2 sites
Yeungnam University Medical Center
Daegu
CHA Bundang Medical Center, CHA University
Seoul
About this study
Official 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
This is a multicenter, randomized, double-blind, placebo-controlled phase II study.
Read the detailed description
is a multicenter, randomized, double-blind, placebo-controlled phase II study. The trial includes a Run-in Period (if stable conventional treatment needed), a 4-week Screening Period, a 12-week Treatment Period, and a 3-week Safety Follow-up Period to Day 105.
90 patients will be centrally, dynamically, randomly assigned to 3 groups (1:1:1) to receive 600mg TJ301 Q2W, 300mg TJ301 Q2W or placebo Q2W.
- Conditions
- Active Ulcerative Colitis
- Being tested
- TJ301 300mg, TJ301 600mg, Placebo
- Keywords
- Randomized, Double-blind, Placebo-controlled, Safety, Efficacy, Active Ulcerative Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TJ301 300mgDrug
TJ301 300mg IV infusion
TJ301 600mgDrug
TJ301 600mg IV infusion
PlaceboDrug
Placebo IV infusion
| Study group | Role | What they receive |
|---|---|---|
| TJ301 300mg | Experimental | TJ301 300mg administrations will occur on Days 0, 14, 28, 42, 56, and 70. Receives: Drug: TJ301 300mg |
| TJ301 600mg | Experimental | TJ301 300mg administrations will occur on Days 0, 14, 28, 42, 56, and 70. Receives: Drug: TJ301 600mg |
| Placebo | Placebo comparator | Placebo administrations will occur on Days 0, 14, 28, 42, 56, and 70. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12
Secondary outcomes (2)
Clinical and endoscopy remission at Week 12
Clinical and endoscopy remission at Week 12, defined as a full Mayo score ≤2, no individual subscore >1, rectal bleeding subscore = 0.
Measured: Week 12.
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.
Measured: Weeks 4, 6, 8, 10, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start6 Feb 2018
- Primary completion21 Dec 2020
- Study completion21 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Active Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-blind, Placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- I-Mab Biopharma HongKong Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Minhu Chen, Doctor, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235752
- Sponsor's protocol ID
- CTJ301UC201
- Status last verified
- Dec 2020
- First submitted
- 28 Jul 2017
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36881032
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03235752
- Acronym / sponsor ID
- CTJ301UC201
- Conditions
- Active Ulcerative Colitis
- Keywords
- Randomized, Double-blind, Placebo-controlled, Safety, Efficacy, Active Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- I-Mab Biopharma HongKong LimitedIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 21 Dec 2020 (actual)
- First posted
- 1 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blind, placebo-controlled phase II study.
Detailed description
is a multicenter, randomized, double-blind, placebo-controlled phase II study. The trial includes a Run-in Period (if stable conventional treatment needed), a 4-week Screening Period, a 12-week Treatment Period, and a 3-week Safety Follow-up Period to Day 105.
90 patients will be centrally, dynamically, randomly assigned to 3 groups (1:1:1) to receive 600mg TJ301 Q2W, 300mg TJ301 Q2W or placebo Q2W.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, Double-blind, Placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| TJ301 300mg | Experimental | Drug: TJ301 300mgTJ301 300mg administrations will occur on Days 0, 14, 28, 42, 56, and 70. |
| TJ301 600mg | Experimental | Drug: TJ301 600mgTJ301 300mg administrations will occur on Days 0, 14, 28, 42, 56, and 70. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administrations will occur on Days 0, 14, 28, 42, 56, and 70. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TJ301 300mgTJ301 300mg IV infusion | Drug | TJ301 300mg |
| TJ301 600mgTJ301 600mg IV infusion | Drug | TJ301 600mg |
| PlaceboPlacebo IV infusion | Drug | Placebo |
Primary outcome
Clinical and endoscopy response
Time frame: Week 12
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.
2 secondary outcomes
Clinical and endoscopy remission at Week 12
Time frame: Week 12.
Clinical remission at Weeks 4, 6, 8, 10, and 12
Time frame: Weeks 4, 6, 8, 10, and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Derived from this study: PubMed 36881032Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minhu Chen, Doctor principal investigator
First Affiliated Hospital, Sun Yat-Sen University
27 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TJ301 300mg and TJ301 600mg in people with Active Ulcerative Colitis, run by I-Mab Biopharma HongKong Limited at 27 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in China, Taiwan, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and endoscopy response (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03235752, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021; AzTrials last refreshed its copy on 26 Oct 2026.