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

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ClinicalTrials.gov Identifier: NCT03235752
Recruitment Status : Completed
First Posted : August 1, 2017
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
I-Mab Biopharma HongKong Limited

Tracking Information
First Submitted Date  ICMJE July 28, 2017
First Posted Date  ICMJE August 1, 2017
Last Update Posted Date January 5, 2021
Actual Study Start Date  ICMJE February 6, 2018
Actual Primary Completion Date December 21, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2021)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 28, 2017)
  • Clinical and endoscopic remission at Week 12 [ Time Frame: Week 12 ]
    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. [ Time Frame: Up to week 15 ]
    Adverse events, vital signs, 12-lead Electrocardiography (ECG), and clinical safety laboratory abnormalities.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2021)
  • Clinical and endoscopy remission at Week 12 [ Time Frame: Week 12. ]
    Clinical and endoscopy remission at Week 12, defined as a full Mayo score ≤2, no individual subscore >1, rectal bleeding subscore = 0.
  • Clinical remission at Weeks 4, 6, 8, 10, and 12 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2017)
  • Clinical and endoscopic response [ Time Frame: Week 12. ]
    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 [ Time Frame: 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.
  • Clinical response at Weeks 4, 6, 8, 10, and 12 [ Time Frame: Weeks 4, 6, 8, 10, and 12 ]
    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 at Week 12 [ Time Frame: Week 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 [ Time Frame: Baseline to Weeks 4, 6, 8, 10, and 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 [ Time Frame: Baseline to Week 12 ]
    Change from Baseline to Week 12 in full Mayo score
  • Change from Baseline to Week 12 in modified Mayo score [ Time Frame: Baseline to Week 12 ]
    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. [ Time Frame: Baseline to Weeks 4, 6, 8, 10, and 12 ]
    Change from Baseline to Weeks 4, 6, 8, 10, and 12 in PGA score.
  • FDA-defined remission at Week 12 [ Time Frame: Week 12 ]
    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. [ Time Frame: Baseline to Week 12 ]
    Immunogenicity: Anti-TJ301 antibodies.
  • PK subgroup:Area under the plasma concentration versus time curve (AUC) [ Time Frame: Baseline to Week 15 ]
    PK subgroup: AUCinf, AUCt, %AUCex
  • PK subgroup:Peak Plasma Concentration (Cmax) [ Time Frame: Baseline to Week 15 ]
    PK subgroup: Cmax
  • PK subgroup:Peak time Tmax [ Time Frame: Baseline to Week 15 ]
    PK subgroup: tmax
  • PK subgroup:Plasma clearance(CL) [ Time Frame: Baseline to Week 15 ]
    PK subgroup: Plasma clearance(CL)
  • PK subgroup:Vz [ Time Frame: Baseline to Week 15 ]
    PK subgroup: Vz
  • PK subgroup:λz [ Time Frame: Baseline to Week 15 ]
    PK subgroup: λz
  • PK subgroup:t½ [ Time Frame: Baseline to Week 15 ]
    PK subgroup: t½
  • PK subgroup:MRT (if applicable) [ Time Frame: Baseline to Week 15 ]
    MRT (if applicable)
  • Peak(pre-infusion) TJ301 serum concentration [ Time Frame: Baseline to Week 15 ]
    Peak(pre-infusion) TJ301 serum concentration
  • Trough(pre-infusion) TJ301 serum concentration [ Time Frame: Baseline to Week 15 ]
    Trough(pre-infusion) TJ301 serum concentration
Current Other Pre-specified Outcome Measures
 (submitted: July 28, 2017)
Change from Baseline to Weeks 4, 8, and 12 in exploratory biomarkers [ Time Frame: Baseline to Weeks 4, 8, and 12 ]
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).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of TJ301 IV in Participants With Active Ulcerative Colitis
Official Title  ICMJE 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
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, Double-blind, Placebo-controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Randomized, Double-blind, Placebo-controlled
Primary Purpose: Treatment
Condition  ICMJE Active Ulcerative Colitis
Intervention  ICMJE
  • Drug: TJ301 300mg
    TJ301 300mg IV infusion
  • Drug: TJ301 600mg
    TJ301 600mg IV infusion
  • Drug: Placebo
    Placebo IV infusion
Study Arms  ICMJE
  • Experimental: TJ301 300mg
    TJ301 300mg administrations will occur on Days 0, 14, 28, 42, 56, and 70.
    Intervention: Drug: TJ301 300mg
  • Experimental: TJ301 600mg
    TJ301 300mg administrations will occur on Days 0, 14, 28, 42, 56, and 70.
    Intervention: Drug: TJ301 600mg
  • Placebo Comparator: Placebo
    Placebo administrations will occur on Days 0, 14, 28, 42, 56, and 70.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 30, 2020)
91
Original Estimated Enrollment  ICMJE
 (submitted: July 28, 2017)
90
Actual Study Completion Date  ICMJE December 21, 2020
Actual Primary Completion Date December 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   Korea, Republic of,   Taiwan
Removed Location Countries Australia
 
Administrative Information
NCT Number  ICMJE NCT03235752
Other Study ID Numbers  ICMJE CTJ301UC201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party I-Mab Biopharma HongKong Limited
Study Sponsor  ICMJE I-Mab Biopharma HongKong Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Minhu Chen, Doctor First Affiliated Hospital, Sun Yat-Sen University
PRS Account I-Mab Biopharma HongKong Limited
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP