search
Back to results

Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis

Primary Purpose

Ulcerative Colitis, Digestive System Diseases, Colitis, Ulcerative

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
KHK4083
Placebo
Sponsored by
Kyowa Kirin, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring 4083-002, Intestinal Diseases, Ulcerative Colitis, UC, Mayo Clinic Scoring, Gastrointestinal Tract

Eligibility Criteria

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

Inclusion Criteria:

  1. Subject is able and willing to comply with study procedures, and to adhere to dosing, visit schedules and follow-up procedures as described in the protocol and ICF;
  2. Subject voluntarily signs/dates an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved ICF in accordance with regulatory and Institutional Guidelines;
  3. Male and female subjects ≥ 18 years of age at the time of enrollment;
  4. Subject has UC that was diagnosed at least 6 months prior to the Screening visit;
  5. Subject has moderately active UC with a total Mayo score of 4-9 and an endoscopic sub-score of at least 2, with disease that extends at least 15 cm from the anal verge;
  6. Subject has had previous treatment (within 5 years prior to Screening) with one or more of the following: corticosteroids, immunosuppressive medications or TNF antagonist therapy that was unsuccessful because of a lack of efficacy response.
  7. Female subjects (WOCBP) must have a negative pregnancy test at Screening and Baseline. WOCBP must agree to use effective contraception;
  8. Male subjects (including those who have had a vasectomy) must use adequate contraception during the study and for at least 6 months after the last dose of investigational product.

Exclusion Criteria:

  1. Subject, who, for any reason, is judged by the Investigator to be inappropriate for this study;
  2. Subject has a medical history of other clinically significant diseases/disorders;
  3. Two or more biologic treatments with different mechanisms of action (e.g., infliximab, vedolizumab and golimumab) or Three or more anti-TNF biologics e.g. infliximab, adalimumab
  4. Subject requires prescription treatment for UC, except for the stable, oral treatment of UC for 4 weeks prior to screening.
  5. Subject has received any of the following prior treatments or treatments within the specified time prior to the Baseline visit:

    • Natalizumab, efalizumab, rituximab or other lymphocyte-depleting treatments, including but not limited, to alkylating agents (such as cyclophosphamide or chlorambucil) and total lymphoid irradiation at any time;
    • TNF antagonists within 8 weeks, or 5 half-lives (up to 12 weeks);
    • Vedolizumab within 16 weeks;
    • Methotrexate, cyclosporine, mycophenolate, tacrolimus, thalidomide, or other immune altering drugs within 4 weeks (ophthalmologic preparations are permitted);
    • 5-ASA enema, steroid enema or suppository use within 2 weeks ; and/or Investigational agents within 8 weeks or 5 half-lives (whichever is longer).
  6. Subject with recent, suspected or confirmed symptomatic stenosis of the colon, abdominal abscess, or ischemic colitis based on clinical or radiographic data; a history of toxic megacolon; or who had any previous surgery for UC;
  7. Subject with known colonic dysplasia, adenomas or polyposis;
  8. Subject had major surgery within 4 weeks prior to Screening or an anticipated requirement for major surgery;
  9. Subject with enteric pathogens (including Clostridium difficile);
  10. Subject with any of the following hematological and chemistry laboratory values:

    • Platelet count < 100,000/mm3;
    • Neutrophils < 1500/mm3;
    • Serum creatinine ≥ 1.6 mg/dL (≥ 144.4 μmol/L);
    • Alkaline phosphatase > 3 times the upper limit of normal (ULN);
    • AST or ALT > 2 times ULN;
    • Total bilirubin > 2 mg/dL, unless due to Gilbert's Syndrome;
    • Serum albumin < 3 g/dL;
    • Hemoglobin < 9 g/dL;
    • Glycated serum hemoglobin A1c ≥ 9%.
  11. Subject has clinically significant cardiac disease;
  12. Subject is pregnant or breastfeeding;
  13. Subject has had major immunologic reaction;
  14. Subject is Hepatitis B core antibody or surface antigen positive and/or Hepatitis C antibody positive with detectable RNA;
  15. Subject has a history of human immunodeficiency virus (HIV) positivity, tests positive for HIV, or has congenital or acquired immunodeficiency;
  16. Subject has or has had active TB, suspected extra-pulmonary TB, a history of incompletely treated TB, or latent TB or other latent infection. Subjects with latent TB (clinical findings, purified protein derivative [PPD] or interferon gamma release assay [IGRA]) may be included in the study if prophylactic therapy for latent TB is started at least 4 weeks prior to Screening. Subjects with a potentially untreated other infection (clinical findings) are to be excluded.
  17. Subject has bacterial infections requiring treatment with oral or parenteral antibiotics, within 2 and 4 weeks, respectively.
  18. Subject has a history of systemic opportunistic infection or recurrent infections
  19. Subject has malignancy or history of malignancy, except for adequately treated basal cell skin cancer or adequately treated carcinoma in-situ of the cervix without recurrence at least 5 years.
  20. Subject who received a bacille Calmette-Guérin (BCG) vaccine within 6 months of randomization or live vaccination (e.g., measles, mumps, rubella [MMR]; herpes zoster; varicella, intranasal influenza; and oral poliomyelitis) within 4 weeks of randomization.
  21. Subject with a history of or active substance abuse.
  22. Subject has other severe acute or chronic medical or psychiatric condition or laboratory abnormality.

Sites / Locations

  • Bežanija Kosa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

KHK4083 Cohort 1

KHK4083 Cohort 2

KHK4083 Cohort 3

KHK4083 Cohort 4

Placebo

Arm Description

Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.

Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.

Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.

Subjects received one maximum tolerated dose (10.0 mg/kg) IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.

Subjects received one IV infusion treatment of Placebo every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects who participated in Open-Label Therapy received KHK4083 instead of placebo.

Outcomes

Primary Outcome Measures

Number of Subjects With Treatment-related Adverse Events
To determine the safety and tolerability of KHK4083
Number of Subjects With Treatment-related Serious Adverse Events
To determine the safety and tolerability of KHK4083
Number of Subjects Who Show Improvement in the Mucosa at Week 12
Measured by the modified Mayo endoscopy sub-score (mMES), which ranges from 0-3 with higher scores = more severe disease.
Proportion of Subjects Who Show Improvement in the Mucosa at Week 52
Measured by the modified Mayo endoscopy sub-score (mMES), which ranges from 0-3 with higher scores = more severe disease.

Secondary Outcome Measures

Number of Subjects With Confirmed Anti-KHK4083 Antibodies (Immunogenicity)
The immunogenicity was assessed by determination of the development of anti-drug antibodies (ADA) against KHK4083.
Number of Subjects Who Achieve Mucosal Healing at Week 12
The endoscopic Mayo Score (Mayo endoscopic subscore) evaluates ulcerative colitis stage, based only on endoscopic exploration. The scale ranges from 0 to 3, with higher scores = more severe activity. Mucosal healing is defined as modified Mayo endoscopy sub-score (mMES) of 0 or 1 at Week 12.
Number of Subjects Who Achieve Mucosal Healing at Week 52
The endoscopic Mayo Score (Mayo endoscopic subscore) evaluates ulcerative colitis stage, based only on endoscopic exploration. The scale ranges from 0 to 3, with higher scores = more severe activity. Mucosal healing is defined as modified Mayo endoscopy sub-score (mMES) of 0 or 1.
Number of Subjects Who Achieve Clinical Improvement at Week 12
The Mayo Clinic Score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and physician's global assessment, each scored from 0-3. The total score ranges from 0-12 with higher scores indicating increased severity of disease. Improvement will be based on a reduction in the total Mayo Clinic score.
Change From Baseline in Total Mayo Scale Score at Week 52
The Mayo Clinic Score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and physician's global assessment, each scored from 0-3. The total score ranges from 0-12 with higher scores indicating increased severity of disease. Improvement was based on a reduction (mean change from Baseline [Week 0] to Week 52) in the total Mayo Clinic score.
Number of Subjects Who Achieve a Clinical Response at Week 12
The Mayo Clinic Score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and physician's global assessment, each scored from 0-3. The total score ranges from 0-12 with higher scores indicating increased severity of disease. Clinical Response is a reduction in the total Mayo Clinic score of at least 3 points.
Number of Subjects Who Achieve a Clinical Response at Week 52
The Mayo Clinic Score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and physician's global assessment, each scored from 0-3. The total score ranges from 0-12 with higher scores indicating increased severity of disease. Clinical Response indicates the change from Baseline in the Total Mayo Clinic score <= -3 and the percentage change from Baseline in the Total Mayo Clinic score <= -30% to Week 12, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of <= 1.
Number of Subjects Who Achieve Clinical Remission at Week 12
The Mayo Clinic Score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and physician's global assessment, each scored from 0-3. The total score ranges from 0-12 with higher scores indicating increased severity of disease. Clinical remission is defined as a total Mayo Clinic score of ≤ 2 and no subscores > 1.
Number of Subjects Who Achieve Clinical Remission at Week 52
The Mayo Clinic Score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and physician's global assessment, each scored from 0-3. The total score ranges from 0-12 with higher scores indicating increased severity of disease. Clinical remission is defined as a total Mayo Clinic score of ≤ 2 and no subscores > 1.

Full Information

First Posted
December 8, 2015
Last Updated
February 21, 2020
Sponsor
Kyowa Kirin, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02647866
Brief Title
Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis
Official Title
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) & Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderately Active UC
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the safety and tolerability of administration of multiple ascending doses of KHK4083 and to select the highest dose tolerated by subjects with moderately active Ulcerative Colitis (UC) followed by a Long-term Extension Therapy (LTE) phase for eligible subjects with a clinical response.
Detailed Description
A Phase 2, double-blind clinical study of multiple ascending doses of KHK4083 (or placebo) with an Long-term Extension Therapy (LTE) phase will be conducted in approximately 60 randomized adult subjects with moderately active UC who have a documented unsuccessful previous treatment. The Treatment Period includes double-blind Induction Therapy (12 weeks) and Open-label Therapy (OLE) phase (40 weeks) for eligible subjects at Week 12. Subjects already enrolled in the double-blind, long-term extension (LTE) under preceding versions of the protocol who worsen may be eligible to transition to the OLE up to Week 28. The Follow Up Period after the last administration will be for up to 16 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Digestive System Diseases, Colitis, Ulcerative, Colitis, Gastrointestinal Diseases, Inflammatory Bowel Diseases, Intestinal Diseases, Colonic Diseases, Autoimmune Disease, Abdominal Pain
Keywords
4083-002, Intestinal Diseases, Ulcerative Colitis, UC, Mayo Clinic Scoring, Gastrointestinal Tract

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Double-blind Induction Therapy was separated into Part A for administration of multiple ascending IV doses of KHK4083 (or placebo) to subjects in Cohorts 1-3 and Part B for administration of the maximally tolerated dose (as determined in cohorts 1-3) in expansion cohort 4. Subjects in Part A were prohibited from participating in Part B. Subjects in each cohort were randomly assigned in a 3:1 ratio to receive KHK4083 or placebo by IV infusion over 60 minutes (± 10 min.). Each subject received a total of 6 treatments (1 IV infusion per treatment) every 2 weeks from Week 0 (Day 1) to Week 10. Subjects who completed double-blind Induction Therapy (i.e., at least 5 of 6 treatments) and had a clinical response or mucosal healing, as defined above, were eligible to continue in double-blind Long Term Extension Therapy (Weeks 12-52) & after protocol amendment all subjects who received at least 5 of 6 treatments were eligible for Open Label Extension Therapy (Weeks 12-52).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KHK4083 Cohort 1
Arm Type
Experimental
Arm Description
Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Arm Title
KHK4083 Cohort 2
Arm Type
Experimental
Arm Description
Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Arm Title
KHK4083 Cohort 3
Arm Type
Experimental
Arm Description
Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Arm Title
KHK4083 Cohort 4
Arm Type
Experimental
Arm Description
Subjects received one maximum tolerated dose (10.0 mg/kg) IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects received one IV infusion treatment of Placebo every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects who participated in Open-Label Therapy received KHK4083 instead of placebo.
Intervention Type
Drug
Intervention Name(s)
KHK4083
Intervention Description
IV Infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
IV Infusion
Primary Outcome Measure Information:
Title
Number of Subjects With Treatment-related Adverse Events
Description
To determine the safety and tolerability of KHK4083
Time Frame
Up to 52 weeks
Title
Number of Subjects With Treatment-related Serious Adverse Events
Description
To determine the safety and tolerability of KHK4083
Time Frame
Up to 52 weeks
Title
Number of Subjects Who Show Improvement in the Mucosa at Week 12
Description
Measured by the modified Mayo endoscopy sub-score (mMES), which ranges from 0-3 with higher scores = more severe disease.
Time Frame
12 weeks
Title
Proportion of Subjects Who Show Improvement in the Mucosa at Week 52
Description
Measured by the modified Mayo endoscopy sub-score (mMES), which ranges from 0-3 with higher scores = more severe disease.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Number of Subjects With Confirmed Anti-KHK4083 Antibodies (Immunogenicity)
Description
The immunogenicity was assessed by determination of the development of anti-drug antibodies (ADA) against KHK4083.
Time Frame
52 weeks
Title
Number of Subjects Who Achieve Mucosal Healing at Week 12
Description
The endoscopic Mayo Score (Mayo endoscopic subscore) evaluates ulcerative colitis stage, based only on endoscopic exploration. The scale ranges from 0 to 3, with higher scores = more severe activity. Mucosal healing is defined as modified Mayo endoscopy sub-score (mMES) of 0 or 1 at Week 12.
Time Frame
12 weeks
Title
Number of Subjects Who Achieve Mucosal Healing at Week 52
Description
The endoscopic Mayo Score (Mayo endoscopic subscore) evaluates ulcerative colitis stage, based only on endoscopic exploration. The scale ranges from 0 to 3, with higher scores = more severe activity. Mucosal healing is defined as modified Mayo endoscopy sub-score (mMES) of 0 or 1.
Time Frame
52 weeks
Title
Number of Subjects Who Achieve Clinical Improvement at Week 12
Description
The Mayo Clinic Score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and physician's global assessment, each scored from 0-3. The total score ranges from 0-12 with higher scores indicating increased severity of disease. Improvement will be based on a reduction in the total Mayo Clinic score.
Time Frame
12 weeks
Title
Change From Baseline in Total Mayo Scale Score at Week 52
Description
The Mayo Clinic Score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and physician's global assessment, each scored from 0-3. The total score ranges from 0-12 with higher scores indicating increased severity of disease. Improvement was based on a reduction (mean change from Baseline [Week 0] to Week 52) in the total Mayo Clinic score.
Time Frame
52 weeks
Title
Number of Subjects Who Achieve a Clinical Response at Week 12
Description
The Mayo Clinic Score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and physician's global assessment, each scored from 0-3. The total score ranges from 0-12 with higher scores indicating increased severity of disease. Clinical Response is a reduction in the total Mayo Clinic score of at least 3 points.
Time Frame
12 weeks
Title
Number of Subjects Who Achieve a Clinical Response at Week 52
Description
The Mayo Clinic Score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and physician's global assessment, each scored from 0-3. The total score ranges from 0-12 with higher scores indicating increased severity of disease. Clinical Response indicates the change from Baseline in the Total Mayo Clinic score <= -3 and the percentage change from Baseline in the Total Mayo Clinic score <= -30% to Week 12, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of <= 1.
Time Frame
52 weeks
Title
Number of Subjects Who Achieve Clinical Remission at Week 12
Description
The Mayo Clinic Score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and physician's global assessment, each scored from 0-3. The total score ranges from 0-12 with higher scores indicating increased severity of disease. Clinical remission is defined as a total Mayo Clinic score of ≤ 2 and no subscores > 1.
Time Frame
12 weeks
Title
Number of Subjects Who Achieve Clinical Remission at Week 52
Description
The Mayo Clinic Score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and physician's global assessment, each scored from 0-3. The total score ranges from 0-12 with higher scores indicating increased severity of disease. Clinical remission is defined as a total Mayo Clinic score of ≤ 2 and no subscores > 1.
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is able and willing to comply with study procedures, and to adhere to dosing, visit schedules and follow-up procedures as described in the protocol and ICF; Subject voluntarily signs/dates an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved ICF in accordance with regulatory and Institutional Guidelines; Male and female subjects ≥ 18 years of age at the time of enrollment; Subject has UC that was diagnosed at least 6 months prior to the Screening visit; Subject has moderately active UC with a total Mayo score of 4-9 and an endoscopic sub-score of at least 2, with disease that extends at least 15 cm from the anal verge; Subject has had previous treatment (within 5 years prior to Screening) with one or more of the following: corticosteroids, immunosuppressive medications or TNF antagonist therapy that was unsuccessful because of a lack of efficacy response. Female subjects (WOCBP) must have a negative pregnancy test at Screening and Baseline. WOCBP must agree to use effective contraception; Male subjects (including those who have had a vasectomy) must use adequate contraception during the study and for at least 6 months after the last dose of investigational product. Exclusion Criteria: Subject, who, for any reason, is judged by the Investigator to be inappropriate for this study; Subject has a medical history of other clinically significant diseases/disorders; Two or more biologic treatments with different mechanisms of action (e.g., infliximab, vedolizumab and golimumab) or Three or more anti-TNF biologics e.g. infliximab, adalimumab Subject requires prescription treatment for UC, except for the stable, oral treatment of UC for 4 weeks prior to screening. Subject has received any of the following prior treatments or treatments within the specified time prior to the Baseline visit: Natalizumab, efalizumab, rituximab or other lymphocyte-depleting treatments, including but not limited, to alkylating agents (such as cyclophosphamide or chlorambucil) and total lymphoid irradiation at any time; TNF antagonists within 8 weeks, or 5 half-lives (up to 12 weeks); Vedolizumab within 16 weeks; Methotrexate, cyclosporine, mycophenolate, tacrolimus, thalidomide, or other immune altering drugs within 4 weeks (ophthalmologic preparations are permitted); 5-ASA enema, steroid enema or suppository use within 2 weeks ; and/or Investigational agents within 8 weeks or 5 half-lives (whichever is longer). Subject with recent, suspected or confirmed symptomatic stenosis of the colon, abdominal abscess, or ischemic colitis based on clinical or radiographic data; a history of toxic megacolon; or who had any previous surgery for UC; Subject with known colonic dysplasia, adenomas or polyposis; Subject had major surgery within 4 weeks prior to Screening or an anticipated requirement for major surgery; Subject with enteric pathogens (including Clostridium difficile); Subject with any of the following hematological and chemistry laboratory values: Platelet count < 100,000/mm3; Neutrophils < 1500/mm3; Serum creatinine ≥ 1.6 mg/dL (≥ 144.4 μmol/L); Alkaline phosphatase > 3 times the upper limit of normal (ULN); AST or ALT > 2 times ULN; Total bilirubin > 2 mg/dL, unless due to Gilbert's Syndrome; Serum albumin < 3 g/dL; Hemoglobin < 9 g/dL; Glycated serum hemoglobin A1c ≥ 9%. Subject has clinically significant cardiac disease; Subject is pregnant or breastfeeding; Subject has had major immunologic reaction; Subject is Hepatitis B core antibody or surface antigen positive and/or Hepatitis C antibody positive with detectable RNA; Subject has a history of human immunodeficiency virus (HIV) positivity, tests positive for HIV, or has congenital or acquired immunodeficiency; Subject has or has had active TB, suspected extra-pulmonary TB, a history of incompletely treated TB, or latent TB or other latent infection. Subjects with latent TB (clinical findings, purified protein derivative [PPD] or interferon gamma release assay [IGRA]) may be included in the study if prophylactic therapy for latent TB is started at least 4 weeks prior to Screening. Subjects with a potentially untreated other infection (clinical findings) are to be excluded. Subject has bacterial infections requiring treatment with oral or parenteral antibiotics, within 2 and 4 weeks, respectively. Subject has a history of systemic opportunistic infection or recurrent infections Subject has malignancy or history of malignancy, except for adequately treated basal cell skin cancer or adequately treated carcinoma in-situ of the cervix without recurrence at least 5 years. Subject who received a bacille Calmette-Guérin (BCG) vaccine within 6 months of randomization or live vaccination (e.g., measles, mumps, rubella [MMR]; herpes zoster; varicella, intranasal influenza; and oral poliomyelitis) within 4 weeks of randomization. Subject with a history of or active substance abuse. Subject has other severe acute or chronic medical or psychiatric condition or laboratory abnormality.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Strout, MBA
Organizational Affiliation
Kyowa Kirin, Inc.
Official's Role
Study Director
Facility Information:
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czechia
City
Znojmo
ZIP/Postal Code
669 02
Country
Czechia
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
City
Budapest
ZIP/Postal Code
H-1032
Country
Hungary
City
Budapest
ZIP/Postal Code
H-1083
Country
Hungary
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
City
Rzeszow
ZIP/Postal Code
35-302
Country
Poland
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
City
Tychy
ZIP/Postal Code
43-100
Country
Poland
City
Warsaw
ZIP/Postal Code
00-632
Country
Poland
City
Warsaw
ZIP/Postal Code
03-580
Country
Poland
City
Warsaw
ZIP/Postal Code
54-239
Country
Poland
City
Bucharest
State/Province
Sector 2
ZIP/Postal Code
020125
Country
Romania
City
Krasnoyarsk
ZIP/Postal Code
660022
Country
Russian Federation
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
City
Penza
ZIP/Postal Code
440026
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
City
Zemun
State/Province
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Bežanija Kosa
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
City
Kragujevac
ZIP/Postal Code
34 000
Country
Serbia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis

We'll reach out to this number within 24 hrs