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A Study Assessing the Efficacy and Safety of CBP-307 in Subjects With Moderate to Severe Ulcerative Colitis (UC)

Primary Purpose

Moderate to Severe Ulcerative Colitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CBP-307
Placebo
Sponsored by
Suzhou Connect Biopharmaceuticals, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate to Severe Ulcerative Colitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-

For the stage 1:

  1. Male or female subjects aged 18-75 years (inclusive).
  2. Female subjects of childbearing potential and male subjects who have not undergone vasectomy should use at least one highly effective methods of contraception during the entire study and 4 weeks after the last dose of investigational products after signing the informed consent form.
  3. The subject has a diagnosis of UC established at least 3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report. Subjects are confirmed to have moderate to severe active UC within 14 days prior to the first dose of the investigational product, which is based on an adapted Mayo score of 4-9, and an endoscopic subscore of ≥ 2. Endoscopy must be performed during the screening period (day -14 to day -3, allowing centralized reading and evaluation before the first dose at week 0).
  4. The subject has evidence of UC extending to the rectum with ≥15 cm involvement on endoscopy.
  5. Subjects must be UC patients who are receiving treatment. They can be enrolled if they meet any items below.

    1. Prior to the randomization visit, subjects have received oral 5-ASA (e.g., mesalazine, sulfasalazine, olsalazine, balsalazide) for at least 4 weeks with the dose stable for at least 2 weeks.
    2. Prior to the randomization visit, subjects have received oral or IV corticosteroids e.g. prednisone (daily doses ≤ 30 mg), budesonide (daily doses ≤ 9 mg), methylprednisolone (daily doses ≤ 24 mg), or equivalent dose of corticosteroids for at least 4 weeks, with the dose stable for at least 2 weeks.
  6. If oral 5-ASA or corticosteroid for treatment of UC have been recently discontinued, they must have been stopped for at least 2 weeks prior to the screening endoscopy examination which is used for Mayo score assessment.
  7. If subjects use non-prohibited concomitant medications, a stable dosing regimen must be used, that is, within 7 days prior to first dose of investigational product or within 5 half lives of the drug (whichever is longer), there's no new concomitant medications started or changes in the dose of existing non-prohibited concomitant medications.
  8. The subject who has extensive colitis or pancolitis of >8 years duration or limited colitis of >12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months prior to initial screening visit (can be performed during Screening if not performed in previous 12 months).

For subjects' entry into the study stage 2 from the stage 1:

  1. Subjects must be those with UC who participate in the study of CBP-307CN002 and have completed 12 weeks of treatment with CBP-307 or placebo in the stage 1 and have completed all the assessments (including colonoscopy) at study visit of week 12 in study stage 1.
  2. Female subjects of childbearing potential and male subjects who have not undergone vasectomy should use at least one highly effective methods of contraception during the entire study and 4 weeks after the last dose of investigational products after signing the informed consent form.

Exclusion Criteria:

-

UC-related exclusion criteria:

  1. At the screening visit, subjects have evidence of toxic megacolon.
  2. The subject has had, subtotal or total colectomy.
  3. The subject has an existing ileostomy, colostomy (a history of ileostomy or colostomy that has been reversed may be acceptable), or known symptomatic stenosis of the intestine.
  4. Investigator judges the subject currently requires or is anticipated to require surgical intervention for UC during the study.
  5. The subject has a history or evidence of adenomatous colonic polyps that have not been removed.
  6. Subjects were previously exposure to the following treatments:

    • Lymphocyte-depleting therapies (e.g., alemtuzumab, anti-CD4 antibody, cladribine, rituximab, ocrelizumab, cyclophosphamide, mitoxantrone, total body irradiation, bone marrow transplantation and daclizumab).
    • Previous treatment with D-penicillamine, leflunomide.
  7. Within 60 days prior to the screening visit, the subject has received any of the following for the treatment of UC:

    1. Intravenous immunoglobulin;
    2. Therapeutic plasma exchange (TPE).
  8. Within 30 days prior to randomization visit, the subject has received any of the following for the treatment of UC:

    1. Immunosuppressants (such as cyclosporine, tacrolimus, sirolimus or mycophenolate mofetil), thalidomide or traditional Chinese medicine;
    2. Approved non-biologic agents or traditional Chinese medicine treatment.
  9. Patients who plan to concurrently use an immunosuppressant (such as azathioprine, 6 mercaptopurine or methotrexate) after randomization. Patients treated with azathioprine, 6-mercaptopurine or methotrexate at screening are required to discontinue it prior to the first dose of the study drug.
  10. The subject has received any investigational biologic or non-biologic agent, or approved biologic agent or biosimilars within 60 days or 5 half-lives prior to screening (whichever is longer).

    Exclusion criteria for general conditions:

  11. History of uveitis or macular oedema.
  12. Clinically relevant cardiovascular conditions, including history or presence of any one of below:

    1. Ischemic heart disease or myocardial infarction; Unstable angina; History of angina pectoris caused by coronary artery spasm, or raynaud's phenomenon (Raynauds);
    2. Congestive heart failure (NYHA class III-IV), cardiac arrest;
    3. Stroke, transient ischemic attack;
    4. History of recurrent syncope or positive result of vasovagal syncope tilt test;
    5. Symptomatic bradycardia, sick sinus syndrome, sinoatrial block, second degree atrioventricular block (e.g., Mobitz type 2 atrioventricular block) or third degree atrioventricular block;
    6. Congenital long QT syndrome (LQTS), or prolonged QT interval corrected using Fridericia's formula (QTcF) in screening ECG (QTcF >450 ms in men, QTcF > 470 ms in women);
    7. Subjects at increased risk for QT prolongation due to hypokalemia or hypomagnesemia; or subjects who currently tacking medications to prolong QT interval (e.g., citalopram, chlorpromazine, haloperidol, methadone, and erythromycin) which result in risk for torsades de pointes;
    8. Under treatment or expected to taking treatment during the study with medications with a known impact on the cardiac conduction system (e.g., beta blockers, calcium channel blockers, Class Ia or Class III anti-arrhythmic drugs. [amiodarone, bromobenzylamine, sotalol, ibutilide, azimilide, dofetilide]);
    9. Hypertension (except well-controlled hypertension after pharmacotherapy); systolic blood pressure < 95 mm Hg or >140 mm Hg and diastolic blood pressure ≤ 50 mm Hg or ≥ 95 mm Hg at the screening visit;
    10. Resting heart rate < 55 times/min or ventricular rate < 55 times/min in 12-lead ECG at screening visit;
    11. Investigator deems that the 12-lead ECG at screening visit is clinically significant abnormal, such as, myocardial ischemia, any significant cardiac conduction abnormalities (such as the left bundle branch block), that would put the subject at risk or interfere with the study results;
    12. Any other significant heart disease that the investigator judges would put the subject at risk or interfere with the study results.
    13. Subjects have a family history of premature coronary heart disease.
  13. History of type 1 diabetes, uncontrolled type 2 diabetes (HbA1c > 7%) judged by investigator, patients with diabetes accompanied with significant complications, e.g., retinopathy or kidney disease.
  14. Pulmonary function test (including examinations of lung ventilation function and pulmonary gas exchange) at the screening visit shows one of the following abnormalities: forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) < 70% of normal expected value.
  15. During screening period, any of the following laboratory abnormalities:

    1. HGB < 8 g/dL;
    2. WBC count < 3.5 × 10E9/L;
    3. Neutrophils count < 1.5 × 10E9/L;
    4. Lymphocyte count < 0.8 × 10E9/L;
    5. Platelet count < 100 × 10E9/L or >1200 × 10E9/L;
    6. Serum creatinine > 124 μmol/L for female or > 141 μmol/L for male;
  16. Abnormal liver function test druring the screening period, such as abonormalities in alanine aminotransferase (ALT), aspartate aminotransferase (AST), γ-glutamyltransferase (γ-GT), alkaline phosphatase (ALK) or serum total bilirubin, which suggests liver diseases or liver function impairment.
  17. If female, the subject is intending to become pregnant before, during, or within 4 weeks after participating in the study or intending to donate ova during such period.
  18. If male, the subject intends to donate sperm during the study or for 4 weeks thereafter.

    Exclusion criteria for infectious diseases:

  19. The subject has evidence of known active infection during the screening period.
  20. The subject has evidence of treatment for Clostridioides difficile (C. difficile) infection or other intestinal pathogen with 28 days prior to first dose of study drug.
  21. Active or latent tuberculosis (TB) evidenced.
  22. Chronic hepatitis B virus (HBV) infection* or chronic hepatitis C virus (HCV) infection**.
  23. The subject has any identified congenital or acquired immunodeficiency (e.g., common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation).
  24. The subject has received any live vaccine within 30 days prior to screening, or subjects are scheduled for immunization with any live vaccine during the study or within 1 month after the last dose of the investigational product.
  25. Positive syphilis antibody at screening.
  26. Subjects with a history of more than one episode of herpes zoster, or a history of disseminated herpes zoster or disseminated herpes simplex.

For subjects' entry into the study stage 2 from the stage 1:

  1. Subjects currently have evidence of active or untreated latent tuberculosis.
  2. Subjects currently have active or chronic recurrent infections, and in the opinion of the investigator subjects are not appropriate to participate in the stage 2 of the study.
  3. History of uveitis or macular oedema.
  4. Subjects had received any of the following treatments after administration of the first dose in the stage 1 of the study:

    • Biological product;
    • Prednisone>30 mg/day, budesonide>9 mg/day, methylprednisolone>24 mg/day or equivalent dose of steroid treatment;
    • Immunosuppressant (such as azathioprine and 6-mercaptopurine or methotrexate).
  5. Investigator deems that the 12-lead ECG results at the study visit of week 12 during study stage 1 is clinically significant abnormal, such as myocardial ischemia, any significant cardiac conduction abnormalities (such as the left bundle branch block), any abnormality that would put the subject at risk or interfere with the study results.
  6. Pulmonary function test (including examinations of lung ventilation function and pulmonary gas exchange) of subjects at the study visit of week 12 during the study stage 1 shows 1 of the following abnormalities: forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) < 50% of normal predicted value.
  7. Subjects' laboratory measurements at week 12 visit during the study stage 1 meet any of the following criteria:

    • AST or ALT> 3 ULN;
    • Absolute lymphocyte count < 0.2×10E9/L;
    • Serum creatinine > 124 μmol/L (in females) or > 141 μmol/L (in males)
  8. Any other reason that in the opinion of the investigator may interfere with subject compliance or evaluation of the results of the study

Sites / Locations

  • Connect Investigative Site 2316
  • Connect Investigative Site 2308
  • Connect Investigative Site 2314
  • Connect Investigative Site 2309
  • Connect Investigative Site 2320
  • Connect Investigative Site 2318
  • Connect Investigative Site 2302
  • Connect Investigative Site 2304
  • Connect Investigative Site 2306
  • Connect Investigative Site 2307
  • Connect Investigative Site 2315
  • Connect Investigative Site 2321
  • Connect Investigative Site 2311
  • Connect Investigative Site 2319
  • Connect Investigative Site 2018
  • Connect Investigative Site 2004
  • Connect Investigative Site 2008
  • Connect Investigative Site 2001
  • Connect Investigative Site 2015
  • Connect Investigative Site 2006
  • Connect Investigative Site 2012
  • Connect Investigative Site 2003
  • Connect Investigative Site 2009
  • Connect Investigative Site 2017
  • Connect Investigative Site 2021
  • Connect Investigative Site 2030
  • Connect Investigative Site 2034
  • Connect Investigative Site 2026
  • Connect Investigative Site 2041
  • Connect Investigative Site 2022
  • Connect Investigative Site 2016
  • Connect Investigative Site 2005
  • Connect Investigative Site 2027
  • Connect Investigative Site 2031
  • Connect Investigative Site 2023
  • Connect Investigative Site 2033
  • Connect Investigative Site 2046
  • Connect Investigative Site 2025
  • Connect Investigative Site 2040
  • Connect Investigative Site 2028
  • Connect Investigative Site 2024
  • Connect Investigative Site 2011
  • Connect Investigative Site 2007
  • Connect Investigative Site 2019
  • Connect Investigative Site 2035
  • Connect Investigative Site 2038
  • Connect Investigative Site 2020
  • Connect Investigative Site 2013
  • Connect Investigative Site 2043
  • Connect Investigative Site 2047
  • Connect Investigative Site 2032
  • Connect Investigative Site 2045
  • Connect Investigative Site 2151
  • Connect Investigative Site 2152
  • Connect Investigative Site 2211
  • Connect Investigative Site 2217
  • Connect Investigative Site 2202
  • Connect Investigative Site 2208
  • Connect Investigative Site 2205
  • Connect Investigative Site 2220
  • Connect Investigative Site 2215
  • Connect Investigative Site 2216
  • Connect Investigative Site 2218
  • Connect Investigative Site 2209
  • Connect Investigative Site 2214

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CBP-307 capsules

Placebo capsules

Arm Description

CBP-307 capsules oral administration.

Placebo capsules oral administration.

Outcomes

Primary Outcome Measures

Adapted Mayo score
Change in adapted Mayo score from baseline at week 12 compared between CBP-307 and placebo

Secondary Outcome Measures

Change in complete Mayo score
Change in complete Mayo score from baseline at week 12 after treatment
Comparison of clinical response rate by adapted Mayo score
Comparison of clinical response rate at week 12 by adapted Mayo score (defined as a decrease of ≥ 2 points and at least 30% from baseline, accompanied with a decrease of ≥ 1 point from baseline in the rectal bleeding subscore or an absolute rectal bleeding subscore of ≤ 1 point).
Comparison of clinical response rate by complete Mayo score
Comparison of clinical response rate at week 12 by complete Mayo score (defined as a decrease of ≥ 3 points and at least 30% from baseline, accompanied with a decrease of ≥ 1 point from baseline in the rectal bleeding subscore or an absolute rectal bleeding subscore of ≤ 1 point).
Comparison of clinical remission rate by adapted Mayo score
Comparison of clinical remission rate at week 12 by adapted Mayo score (defined as a rectal bleeding subscore = 0 and a stool frequency subscore ≤ 1, with an Endoscopy subscore ≤ 1 [excluding friability]).
Comparison of clinical remission rate by complete Mayo score
Comparison of clinical remission rate at week 12 by complete Mayo score (defined as a total Mayo score of ≤ 2 points with no individual subscore > 1 point).
Mucosal healing rate
Mucosal healing rate at week 12 after treatment (mucosal healing is defined as Mayo endoscopic subscore ≤ 1)
Incidence, type and severity of Treatment Emergent Adverse Event (TEAE)
The safety and tolerability will be assessed on basis of incidence, type and severity of TEAEs as well as their relations with the investigational product .
Incidence, type and severity of Serious Adverse Event (SAE)
The safety and tolerability will be assessed on basis of incidence, type and severity of SAEs as well as their relations with the investigational product and SAEs that lead to discontinuation of study.
Incidence, type and severity of Adverse Events (AE)
The safety and tolerability will be assessed on basis of AEs that lead to discontinuation of study, and AEs of special interest (cardiac events as well as pulmonary function tests, ophthalmologic examinations, skin examinations, and nervous system physical examinations)

Full Information

First Posted
October 22, 2020
Last Updated
March 6, 2023
Sponsor
Suzhou Connect Biopharmaceuticals, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04700449
Brief Title
A Study Assessing the Efficacy and Safety of CBP-307 in Subjects With Moderate to Severe Ulcerative Colitis (UC)
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of CBP-307 in Subjects With Moderate to Severe Ulcerative Colitis (UC)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 27, 2019 (Actual)
Primary Completion Date
February 23, 2022 (Actual)
Study Completion Date
November 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Connect Biopharmaceuticals, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the efficacy and safety of CBP-307 in subjects with moderate to severe ulcerative colitis (UC).
Detailed Description
This is a multicenter, multicountry, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the efficacy and safety of CBP-307 in subjects with moderate to severe ulcerative colitis (UC). CBP-307 capsules are administered orally. This study includes stage 1 and stage 2. After screening, subjects will enter the randomized, double-blind, placebo-controlled induction therapy for 12 weeks, i.e., the study stage 1. All subjects who complete 12 weeks of induction therapy (with CBP-307 or placebo) in the study stage 1 and complete all examinations (including colonoscopy) at the week 12 visit can choose to enter the study stage 2 of a total of 40 weeks, including 36 weeks of continuous administration and 4 weeks of safety follow-up after the last dose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBP-307 capsules
Arm Type
Experimental
Arm Description
CBP-307 capsules oral administration.
Arm Title
Placebo capsules
Arm Type
Placebo Comparator
Arm Description
Placebo capsules oral administration.
Intervention Type
Drug
Intervention Name(s)
CBP-307
Intervention Description
CBP-307 capsules oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules oral administration
Primary Outcome Measure Information:
Title
Adapted Mayo score
Description
Change in adapted Mayo score from baseline at week 12 compared between CBP-307 and placebo
Time Frame
at Week 12
Secondary Outcome Measure Information:
Title
Change in complete Mayo score
Description
Change in complete Mayo score from baseline at week 12 after treatment
Time Frame
at Week 12
Title
Comparison of clinical response rate by adapted Mayo score
Description
Comparison of clinical response rate at week 12 by adapted Mayo score (defined as a decrease of ≥ 2 points and at least 30% from baseline, accompanied with a decrease of ≥ 1 point from baseline in the rectal bleeding subscore or an absolute rectal bleeding subscore of ≤ 1 point).
Time Frame
at Week 12
Title
Comparison of clinical response rate by complete Mayo score
Description
Comparison of clinical response rate at week 12 by complete Mayo score (defined as a decrease of ≥ 3 points and at least 30% from baseline, accompanied with a decrease of ≥ 1 point from baseline in the rectal bleeding subscore or an absolute rectal bleeding subscore of ≤ 1 point).
Time Frame
at Week 12
Title
Comparison of clinical remission rate by adapted Mayo score
Description
Comparison of clinical remission rate at week 12 by adapted Mayo score (defined as a rectal bleeding subscore = 0 and a stool frequency subscore ≤ 1, with an Endoscopy subscore ≤ 1 [excluding friability]).
Time Frame
at Week 12
Title
Comparison of clinical remission rate by complete Mayo score
Description
Comparison of clinical remission rate at week 12 by complete Mayo score (defined as a total Mayo score of ≤ 2 points with no individual subscore > 1 point).
Time Frame
at Week 12
Title
Mucosal healing rate
Description
Mucosal healing rate at week 12 after treatment (mucosal healing is defined as Mayo endoscopic subscore ≤ 1)
Time Frame
at Week 12
Title
Incidence, type and severity of Treatment Emergent Adverse Event (TEAE)
Description
The safety and tolerability will be assessed on basis of incidence, type and severity of TEAEs as well as their relations with the investigational product .
Time Frame
for 12 consecutive weeks
Title
Incidence, type and severity of Serious Adverse Event (SAE)
Description
The safety and tolerability will be assessed on basis of incidence, type and severity of SAEs as well as their relations with the investigational product and SAEs that lead to discontinuation of study.
Time Frame
for 12 consecutive weeks
Title
Incidence, type and severity of Adverse Events (AE)
Description
The safety and tolerability will be assessed on basis of AEs that lead to discontinuation of study, and AEs of special interest (cardiac events as well as pulmonary function tests, ophthalmologic examinations, skin examinations, and nervous system physical examinations)
Time Frame
for 12 consecutive weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - For the stage 1: Male or female subjects aged 18-75 years (inclusive). Female subjects of childbearing potential and male subjects who have not undergone vasectomy should use at least one highly effective methods of contraception during the entire study and 4 weeks after the last dose of investigational products after signing the informed consent form. The subject has a diagnosis of UC established at least 3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report. Subjects are confirmed to have moderate to severe active UC within 14 days prior to the first dose of the investigational product, which is based on an adapted Mayo score of 4-9, and an endoscopic subscore of ≥ 2. Endoscopy must be performed during the screening period (day -14 to day -3, allowing centralized reading and evaluation before the first dose at week 0). The subject has evidence of UC extending to the rectum with ≥15 cm involvement on endoscopy. Subjects must be UC patients who are receiving treatment. They can be enrolled if they meet any items below. Prior to the randomization visit, subjects have received oral 5-ASA (e.g., mesalazine, sulfasalazine, olsalazine, balsalazide) for at least 4 weeks with the dose stable for at least 2 weeks. Prior to the randomization visit, subjects have received oral or IV corticosteroids e.g. prednisone (daily doses ≤ 30 mg), budesonide (daily doses ≤ 9 mg), methylprednisolone (daily doses ≤ 24 mg), or equivalent dose of corticosteroids for at least 4 weeks, with the dose stable for at least 2 weeks. If oral 5-ASA or corticosteroid for treatment of UC have been recently discontinued, they must have been stopped for at least 2 weeks prior to the screening endoscopy examination which is used for Mayo score assessment. If subjects use non-prohibited concomitant medications, a stable dosing regimen must be used, that is, within 7 days prior to first dose of investigational product or within 5 half lives of the drug (whichever is longer), there's no new concomitant medications started or changes in the dose of existing non-prohibited concomitant medications. The subject who has extensive colitis or pancolitis of >8 years duration or limited colitis of >12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months prior to initial screening visit (can be performed during Screening if not performed in previous 12 months). For subjects' entry into the study stage 2 from the stage 1: Subjects must be those with UC who participate in the study of CBP-307CN002 and have completed 12 weeks of treatment with CBP-307 or placebo in the stage 1 and have completed all the assessments (including colonoscopy) at study visit of week 12 in study stage 1. Female subjects of childbearing potential and male subjects who have not undergone vasectomy should use at least one highly effective methods of contraception during the entire study and 4 weeks after the last dose of investigational products after signing the informed consent form. Exclusion Criteria: - UC-related exclusion criteria: At the screening visit, subjects have evidence of toxic megacolon. The subject has had, subtotal or total colectomy. The subject has an existing ileostomy, colostomy (a history of ileostomy or colostomy that has been reversed may be acceptable), or known symptomatic stenosis of the intestine. Investigator judges the subject currently requires or is anticipated to require surgical intervention for UC during the study. The subject has a history or evidence of adenomatous colonic polyps that have not been removed. Subjects were previously exposure to the following treatments: Lymphocyte-depleting therapies (e.g., alemtuzumab, anti-CD4 antibody, cladribine, rituximab, ocrelizumab, cyclophosphamide, mitoxantrone, total body irradiation, bone marrow transplantation and daclizumab). Previous treatment with D-penicillamine, leflunomide. Within 60 days prior to the screening visit, the subject has received any of the following for the treatment of UC: Intravenous immunoglobulin; Therapeutic plasma exchange (TPE). Within 30 days prior to randomization visit, the subject has received any of the following for the treatment of UC: Immunosuppressants (such as cyclosporine, tacrolimus, sirolimus or mycophenolate mofetil), thalidomide or traditional Chinese medicine; Approved non-biologic agents or traditional Chinese medicine treatment. Patients who plan to concurrently use an immunosuppressant (such as azathioprine, 6 mercaptopurine or methotrexate) after randomization. Patients treated with azathioprine, 6-mercaptopurine or methotrexate at screening are required to discontinue it prior to the first dose of the study drug. The subject has received any investigational biologic or non-biologic agent, or approved biologic agent or biosimilars within 60 days or 5 half-lives prior to screening (whichever is longer). Exclusion criteria for general conditions: History of uveitis or macular oedema. Clinically relevant cardiovascular conditions, including history or presence of any one of below: Ischemic heart disease or myocardial infarction; Unstable angina; History of angina pectoris caused by coronary artery spasm, or raynaud's phenomenon (Raynauds); Congestive heart failure (NYHA class III-IV), cardiac arrest; Stroke, transient ischemic attack; History of recurrent syncope or positive result of vasovagal syncope tilt test; Symptomatic bradycardia, sick sinus syndrome, sinoatrial block, second degree atrioventricular block (e.g., Mobitz type 2 atrioventricular block) or third degree atrioventricular block; Congenital long QT syndrome (LQTS), or prolonged QT interval corrected using Fridericia's formula (QTcF) in screening ECG (QTcF >450 ms in men, QTcF > 470 ms in women); Subjects at increased risk for QT prolongation due to hypokalemia or hypomagnesemia; or subjects who currently tacking medications to prolong QT interval (e.g., citalopram, chlorpromazine, haloperidol, methadone, and erythromycin) which result in risk for torsades de pointes; Under treatment or expected to taking treatment during the study with medications with a known impact on the cardiac conduction system (e.g., beta blockers, calcium channel blockers, Class Ia or Class III anti-arrhythmic drugs. [amiodarone, bromobenzylamine, sotalol, ibutilide, azimilide, dofetilide]); Hypertension (except well-controlled hypertension after pharmacotherapy); systolic blood pressure < 95 mm Hg or >140 mm Hg and diastolic blood pressure ≤ 50 mm Hg or ≥ 95 mm Hg at the screening visit; Resting heart rate < 55 times/min or ventricular rate < 55 times/min in 12-lead ECG at screening visit; Investigator deems that the 12-lead ECG at screening visit is clinically significant abnormal, such as, myocardial ischemia, any significant cardiac conduction abnormalities (such as the left bundle branch block), that would put the subject at risk or interfere with the study results; Any other significant heart disease that the investigator judges would put the subject at risk or interfere with the study results. Subjects have a family history of premature coronary heart disease. History of type 1 diabetes, uncontrolled type 2 diabetes (HbA1c > 7%) judged by investigator, patients with diabetes accompanied with significant complications, e.g., retinopathy or kidney disease. Pulmonary function test (including examinations of lung ventilation function and pulmonary gas exchange) at the screening visit shows one of the following abnormalities: forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) < 70% of normal expected value. During screening period, any of the following laboratory abnormalities: HGB < 8 g/dL; WBC count < 3.5 × 10E9/L; Neutrophils count < 1.5 × 10E9/L; Lymphocyte count < 0.8 × 10E9/L; Platelet count < 100 × 10E9/L or >1200 × 10E9/L; Serum creatinine > 124 μmol/L for female or > 141 μmol/L for male; Abnormal liver function test druring the screening period, such as abonormalities in alanine aminotransferase (ALT), aspartate aminotransferase (AST), γ-glutamyltransferase (γ-GT), alkaline phosphatase (ALK) or serum total bilirubin, which suggests liver diseases or liver function impairment. If female, the subject is intending to become pregnant before, during, or within 4 weeks after participating in the study or intending to donate ova during such period. If male, the subject intends to donate sperm during the study or for 4 weeks thereafter. Exclusion criteria for infectious diseases: The subject has evidence of known active infection during the screening period. The subject has evidence of treatment for Clostridioides difficile (C. difficile) infection or other intestinal pathogen with 28 days prior to first dose of study drug. Active or latent tuberculosis (TB) evidenced. Chronic hepatitis B virus (HBV) infection* or chronic hepatitis C virus (HCV) infection**. The subject has any identified congenital or acquired immunodeficiency (e.g., common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation). The subject has received any live vaccine within 30 days prior to screening, or subjects are scheduled for immunization with any live vaccine during the study or within 1 month after the last dose of the investigational product. Positive syphilis antibody at screening. Subjects with a history of more than one episode of herpes zoster, or a history of disseminated herpes zoster or disseminated herpes simplex. For subjects' entry into the study stage 2 from the stage 1: Subjects currently have evidence of active or untreated latent tuberculosis. Subjects currently have active or chronic recurrent infections, and in the opinion of the investigator subjects are not appropriate to participate in the stage 2 of the study. History of uveitis or macular oedema. Subjects had received any of the following treatments after administration of the first dose in the stage 1 of the study: Biological product; Prednisone>30 mg/day, budesonide>9 mg/day, methylprednisolone>24 mg/day or equivalent dose of steroid treatment; Immunosuppressant (such as azathioprine and 6-mercaptopurine or methotrexate). Investigator deems that the 12-lead ECG results at the study visit of week 12 during study stage 1 is clinically significant abnormal, such as myocardial ischemia, any significant cardiac conduction abnormalities (such as the left bundle branch block), any abnormality that would put the subject at risk or interfere with the study results. Pulmonary function test (including examinations of lung ventilation function and pulmonary gas exchange) of subjects at the study visit of week 12 during the study stage 1 shows 1 of the following abnormalities: forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) < 50% of normal predicted value. Subjects' laboratory measurements at week 12 visit during the study stage 1 meet any of the following criteria: AST or ALT> 3 ULN; Absolute lymphocyte count < 0.2×10E9/L; Serum creatinine > 124 μmol/L (in females) or > 141 μmol/L (in males) Any other reason that in the opinion of the investigator may interfere with subject compliance or evaluation of the results of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzhou Connect
Organizational Affiliation
Suzhou Connect Biopharmaceuticals, Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Connect Investigative Site 2316
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Connect Investigative Site 2308
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Connect Investigative Site 2314
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Connect Investigative Site 2309
City
Homestead
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Facility Name
Connect Investigative Site 2320
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Connect Investigative Site 2318
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Connect Investigative Site 2302
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Connect Investigative Site 2304
City
Orlando
State/Province
Florida
ZIP/Postal Code
32810
Country
United States
Facility Name
Connect Investigative Site 2306
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
Connect Investigative Site 2307
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Connect Investigative Site 2315
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Connect Investigative Site 2321
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73102
Country
United States
Facility Name
Connect Investigative Site 2311
City
Cypress
State/Province
Texas
ZIP/Postal Code
90212
Country
United States
Facility Name
Connect Investigative Site 2319
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Connect Investigative Site 2018
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
Connect Investigative Site 2004
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Name
Connect Investigative Site 2008
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Connect Investigative Site 2001
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Connect Investigative Site 2015
City
Jilin
State/Province
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
Connect Investigative Site 2006
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
Connect Investigative Site 2012
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361004
Country
China
Facility Name
Connect Investigative Site 2003
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Connect Investigative Site 2009
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Facility Name
Connect Investigative Site 2017
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518035
Country
China
Facility Name
Connect Investigative Site 2021
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518053
Country
China
Facility Name
Connect Investigative Site 2030
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
168600
Country
China
Facility Name
Connect Investigative Site 2034
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Facility Name
Connect Investigative Site 2026
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Name
Connect Investigative Site 2041
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050011
Country
China
Facility Name
Connect Investigative Site 2022
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Connect Investigative Site 2016
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Connect Investigative Site 2005
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Connect Investigative Site 2027
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
Connect Investigative Site 2031
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Facility Name
Connect Investigative Site 2023
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210036
Country
China
Facility Name
Connect Investigative Site 2033
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Facility Name
Connect Investigative Site 2046
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Connect Investigative Site 2025
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116027
Country
China
Facility Name
Connect Investigative Site 2040
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
117004
Country
China
Facility Name
Connect Investigative Site 2028
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Name
Connect Investigative Site 2024
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
Facility Name
Connect Investigative Site 2011
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Connect Investigative Site 2007
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Connect Investigative Site 2019
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200065
Country
China
Facility Name
Connect Investigative Site 2035
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
Connect Investigative Site 2038
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Connect Investigative Site 2020
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Facility Name
Connect Investigative Site 2013
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Connect Investigative Site 2043
City
Chongqing
State/Province
Sichuan
ZIP/Postal Code
400037
Country
China
Facility Name
Connect Investigative Site 2047
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Connect Investigative Site 2032
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Connect Investigative Site 2045
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China
Facility Name
Connect Investigative Site 2151
City
Karachi
State/Province
Sindh Province
ZIP/Postal Code
74800
Country
Pakistan
Facility Name
Connect Investigative Site 2152
City
Karachi
State/Province
Sindh Province
ZIP/Postal Code
75270
Country
Pakistan
Facility Name
Connect Investigative Site 2211
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Connect Investigative Site 2217
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Connect Investigative Site 2202
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
Connect Investigative Site 2208
City
Kharkiv
ZIP/Postal Code
61124
Country
Ukraine
Facility Name
Connect Investigative Site 2205
City
Kyiv
ZIP/Postal Code
1135
Country
Ukraine
Facility Name
Connect Investigative Site 2220
City
Kyiv
ZIP/Postal Code
8173
Country
Ukraine
Facility Name
Connect Investigative Site 2215
City
Lviv
ZIP/Postal Code
79005
Country
Ukraine
Facility Name
Connect Investigative Site 2216
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Connect Investigative Site 2218
City
Uzhhorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Connect Investigative Site 2209
City
Vinnytsia
ZIP/Postal Code
21021
Country
Ukraine
Facility Name
Connect Investigative Site 2214
City
Zaporizhzhia
ZIP/Postal Code
69035
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study Assessing the Efficacy and Safety of CBP-307 in Subjects With Moderate to Severe Ulcerative Colitis (UC)

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