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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 : Recruiting
First Posted : August 1, 2017
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
I-Mab Biopharma HongKong Limited

Brief Summary:
This is a multicenter, randomized, double-blind, placebo-controlled phase II study.

Condition or disease Intervention/treatment Phase
Active Ulcerative Colitis Drug: TJ301 300mg Drug: TJ301 600mg Drug: Placebo Phase 2

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 biweekly (Q2W), 300mg TJ301 Q2W or placebo Q2W.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
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
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
Actual Study Start Date : February 6, 2018
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : June 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TJ301 300mg
TJ301 300mg administrations will occur on Days 0, 14, 28, 42, 56, and 70.
Drug: TJ301 300mg
TJ301 300mg IV infusion

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

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. 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).



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03235752


Contacts
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Contact: Yonghong Jia, Master +8618513849471 yonghong.jia@i-mabbiopharma.com

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Sponsors and Collaborators
I-Mab Biopharma HongKong Limited
Investigators
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Principal Investigator: Minhu Chen, Doctor First Affiliated Hospital, Sun Yat-Sen University

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Responsible Party: I-Mab Biopharma HongKong Limited
ClinicalTrials.gov Identifier: NCT03235752     History of Changes
Other Study ID Numbers: CTJ301UC201
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by I-Mab Biopharma HongKong Limited:
Randomized
Double-blind
Placebo-controlled
Safety
Efficacy
Active Ulcerative Colitis
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases