Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis
Sponsor
Kyowa Kirin, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02647866
Collaborator
(none)
66
23
5
28
2.9
0.1
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
66 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention 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).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:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Jun 1, 2016
Actual Primary Completion Date
:
Sep 1, 2018
Actual Study Completion Date
:
Oct 1, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: KHK4083 Cohort 1 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. |
Drug: KHK4083
IV Infusion
|
| Experimental: KHK4083 Cohort 2 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. |
Drug: KHK4083
IV Infusion
|
| Experimental: KHK4083 Cohort 3 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. |
Drug: KHK4083
IV Infusion
|
| Experimental: KHK4083 Cohort 4 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. |
Drug: KHK4083
IV Infusion
|
| Placebo Comparator: Placebo 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. |
Drug: Placebo
IV Infusion
|
Outcome Measures
Primary Outcome Measures
- Number of Subjects With Treatment-related Adverse Events [Up to 52 weeks]
To determine the safety and tolerability of KHK4083
- Number of Subjects With Treatment-related Serious Adverse Events [Up to 52 weeks]
To determine the safety and tolerability of KHK4083
- Number of Subjects Who Show Improvement in the Mucosa at Week 12 [12 weeks]
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 [52 weeks]
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) [52 weeks]
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 [12 weeks]
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 [52 weeks]
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 [12 weeks]
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 [52 weeks]
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 [12 weeks]
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 [52 weeks]
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 [12 weeks]
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 [52 weeks]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Greenville | South Carolina | United States | 29615 | |
| 2 | Hradec Kralove | Czechia | 500 12 | ||
| 3 | Znojmo | Czechia | 669 02 | ||
| 4 | Budapest | Hungary | 1125 | ||
| 5 | Budapest | Hungary | H-1032 | ||
| 6 | Budapest | Hungary | H-1083 | ||
| 7 | Bydgoszcz | Poland | 85-168 | ||
| 8 | Rzeszow | Poland | 35-302 | ||
| 9 | Sopot | Poland | 81-756 | ||
| 10 | Tychy | Poland | 43-100 | ||
| 11 | Warsaw | Poland | 00-632 | ||
| 12 | Warsaw | Poland | 03-580 | ||
| 13 | Warsaw | Poland | 54-239 | ||
| 14 | Bucharest | Sector 2 | Romania | 020125 | |
| 15 | Krasnoyarsk | Russian Federation | 660022 | ||
| 16 | Moscow | Russian Federation | 129110 | ||
| 17 | Novosibirsk | Russian Federation | 630091 | ||
| 18 | Penza | Russian Federation | 440026 | ||
| 19 | St. Petersburg | Russian Federation | 194354 | ||
| 20 | St. Petersburg | Russian Federation | 196247 | ||
| 21 | Zemun | Belgrade | Serbia | 11080 | |
| 22 | Bežanija Kosa | Belgrade | Serbia | 11080 | |
| 23 | Kragujevac | Serbia | 34 000 |
Sponsors and Collaborators
- Kyowa Kirin, Inc.
Investigators
- Study Director: Vincent Strout, MBA, Kyowa Kirin, Inc.
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Kyowa Kirin, Inc.
ClinicalTrials.gov Identifier:
NCT02647866
Other Study ID Numbers:
- 4083-002
First Posted:
Jan 6, 2016
Last Update Posted:
Mar 5, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Kyowa Kirin, Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Investigative sites in the US, Poland, Czech Republic, Russia, Romania, Serbia, and Hungary screened patients from January 2016 until June 2017, with the first patient enrolled in June 2016. |
|---|---|
| Pre-assignment Detail | A total of 109 patients were screened during the recruiting period. Subjects were enrolled into the study only if all inclusion criteria and none of the exclusion criteria were fulfilled. |
| Arm/Group Title | KHK4083 Cohort 1 | KHK4083 Cohort 2 | KHK4083 Cohort 3 | KHK4083 Cohort 4 | Placebo |
|---|---|---|---|---|---|
| Arm/Group 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. |
| Period Title: Overall Study | |||||
| STARTED | 9 | 10 | 9 | 21 | 17 |
| Completed Induction Therapy | 8 | 9 | 8 | 19 | 17 |
| Completed Induction Therapy Follow-Up | 5 | 1 | 2 | 0 | 2 |
| Completed Long-Term Extension Therapy | 3 | 0 | 0 | 0 | 0 |
| Completed LTE Follow-up | 2 | 0 | 0 | 0 | 0 |
| Completed Open-Label Extension Therapy | 0 | 7 | 4 | 17 | 13 |
| Completed OLE Follow-up | 0 | 6 | 4 | 14 | 10 |
| Moved From LTE to OLE Therapy | 0 | 5 | 0 | 0 | 2 |
| Discontinued the Treatment | 4 | 5 | 5 | 5 | 8 |
| Discontinued the Study | 5 | 4 | 5 | 6 | 8 |
| COMPLETED | 4 | 6 | 4 | 15 | 9 |
| NOT COMPLETED | 5 | 4 | 5 | 6 | 8 |
Baseline Characteristics
| Arm/Group Title | KHK4083 Cohort 1 | KHK4083 Cohort 2 | KHK4083 Cohort 3 | KHK4083 Cohort 4 | Placebo | Total |
|---|---|---|---|---|---|---|
| Arm/Group 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. | Total of all reporting groups |
| Overall Participants | 9 | 10 | 9 | 21 | 17 | 66 |
| Age (Count of Participants) | ||||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
7
77.8%
|
8
80%
|
9
100%
|
19
90.5%
|
17
100%
|
60
90.9%
|
| >=65 years |
2
22.2%
|
2
20%
|
0
0%
|
2
9.5%
|
0
0%
|
6
9.1%
|
| Age (years) [Mean (Full Range) ] | ||||||
| Mean (Full Range) [years] |
47.3
|
46.1
|
41.2
|
41.1
|
33.8
|
40.8
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
4
44.4%
|
2
20%
|
5
55.6%
|
6
28.6%
|
8
47.1%
|
25
37.9%
|
| Male |
5
55.6%
|
8
80%
|
4
44.4%
|
15
71.4%
|
9
52.9%
|
41
62.1%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
9
100%
|
10
100%
|
9
100%
|
21
100%
|
17
100%
|
66
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
5.9%
|
1
1.5%
|
| White |
9
100%
|
10
100%
|
9
100%
|
21
100%
|
16
94.1%
|
65
98.5%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Number of Subjects With Treatment-related Adverse Events |
|---|---|
| Description | To determine the safety and tolerability of KHK4083 |
| Time Frame | Up to 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Analysis Set - All randomized subjects who received any (even partial dose) investigational product (KHK4083 or placebo). |
| Arm/Group Title | KHK4083 Cohort 1 | KHK4083 Cohort 2 | KHK4083 Cohort 3 | KHK4083 Cohort 4 | KHK4083 Combined | Placebo |
|---|---|---|---|---|---|---|
| Arm/Group 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. | The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy. | Subjects received placebo IV infusion treatments from Baseline to Week 12. Subjects who completed double-blind Induction Therapy (i.e., at least five of six treatments) were eligible to enter OLE Therapy and receive 10 treatments of open-label KHK4083 (at the same dose administered to that subject during Induction Therapy) as maintenance therapy. Each subject was to receive one IV infusion every 4 weeks from Week 12 to Week 48. |
| Measure Participants | 9 | 10 | 9 | 21 | 49 | 17 |
| With Any TEAE |
5
55.6%
|
7
70%
|
7
77.8%
|
14
66.7%
|
33
194.1%
|
13
19.7%
|
| With Any Drug-related TEAE |
3
33.3%
|
2
20%
|
3
33.3%
|
3
14.3%
|
11
64.7%
|
2
3%
|
| With Any TEAE with an Outcome of Death |
0
0%
|
1
10%
|
0
0%
|
0
0%
|
1
5.9%
|
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Analysis Set - All randomized subjects who received any (even partial dose) investigational product (KHK4083 or placebo). |
| Arm/Group Title | KHK4083 Cohort 1 | KHK4083 Cohort 2 | KHK4083 Cohort 3 | KHK4083 Cohort 4 | KHK4083 Combined | Placebo |
|---|---|---|---|---|---|---|
| Arm/Group 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. | The total number of participants analyzed who received KHK4083 during Induction Therapy. | 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. |
| Measure Participants | 9 | 10 | 9 | 21 | 49 | 17 |
| With Any Serious TEAE |
1
11.1%
|
1
10%
|
1
11.1%
|
3
14.3%
|
6
35.3%
|
3
4.5%
|
| With Any Drug-related Serious TEAE |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Who Died |
0
0%
|
1
10%
|
0
0%
|
0
0%
|
1
5.9%
|
0
0%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set - All randomized subjects who received at least one full dose of investigational product and had a Baseline and at least one post-treatment primary efficacy variable. |
| Arm/Group Title | KHK4083 Cohort 1 | KHK4083 Cohort 2 | KHK4083 Cohorts 3 + 4 Combined | KHK4083 Combined | Placebo |
|---|---|---|---|---|---|
| Arm/Group 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. | The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy. | 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. |
| Measure Participants | 7 | 8 | 22 | 37 | 15 |
| mMES Improvement |
2
22.2%
|
4
40%
|
9
100%
|
15
71.4%
|
5
29.4%
|
| Modified Baron Endoscopic Score Improvement |
3
33.3%
|
5
50%
|
8
88.9%
|
16
76.2%
|
6
35.3%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | KHK4083 Cohort 1 | KHK4083 Cohort 2 | KHK4083 Cohorts 3 + 4 Combined | KHK4083 Combined | Placebo |
|---|---|---|---|---|---|
| Arm/Group 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. | The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy, | 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. |
| Measure Participants | 7 | 8 | 21 | 36 | 14 |
| Count of Participants [Participants] |
1
11.1%
|
3
30%
|
9
100%
|
13
61.9%
|
4
23.5%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All subjects who received at least one dose of KHK4083, including 14 subjects initially randomized to placebo and who then continued into Open-Label Extension therapy, where they received the maximum tolerated dose of KHK4083. |
| Arm/Group Title | KHK4083 Cohort 1 | KHK4083 Cohort 2 | KHK4083 Cohort 3 | KHK4083 Cohort 4 | Placebo |
|---|---|---|---|---|---|
| Arm/Group 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. |
| Measure Participants | 9 | 10 | 9 | 21 | 14 |
| Subjects with Pre-Existing ADA at Baseline |
1
11.1%
|
2
20%
|
1
11.1%
|
0
0%
|
1
5.9%
|
| Subjects with Production of Treatment-Induced ADA |
3
33.3%
|
0
0%
|
1
11.1%
|
5
23.8%
|
4
23.5%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set - All randomized subjects who received at least one full dose of investigational product and had a Baseline and at least one post-treatment primary efficacy variable. |
| Arm/Group Title | KHK4083 Cohort 1 | KHK4083 Cohort 2 | KHK4083 Cohorts 3 + 4 Combined | KHK4083 Combined | Placebo |
|---|---|---|---|---|---|
| Arm/Group 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. | The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy. | 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. |
| Measure Participants | 7 | 8 | 22 | 37 | 15 |
| Count of Participants [Participants] |
1
11.1%
|
3
30%
|
8
88.9%
|
12
57.1%
|
4
23.5%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | KHK4083 Cohort 1 | KHK4083 Cohort 2 | KHK4083 Cohorts 3 + 4 Combined | KHK4083 Combined | Placebo |
|---|---|---|---|---|---|
| Arm/Group 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. | The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy. | 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. |
| Measure Participants | 7 | 8 | 21 | 36 | 14 |
| Count of Participants [Participants] |
1
11.1%
|
3
30%
|
7
77.8%
|
11
52.4%
|
3
17.6%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set - All randomized subjects who received at least one full dose of investigational product and had a Baseline and at least one post-treatment primary efficacy variable. |
| Arm/Group Title | KHK4083 Cohort 1 | KHK4083 Cohort 2 | KHK4083 Cohorts 3 + 4 Combined | KHK4083 Combined | Placebo |
|---|---|---|---|---|---|
| Arm/Group 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. | The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy. | 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. |
| Measure Participants | 7 | 8 | 22 | 37 | 15 |
| Count of Participants [Participants] |
2
22.2%
|
4
40%
|
9
100%
|
15
71.4%
|
5
29.4%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The overall number of participants is the number in the full analysis set. The number of patients analyzed is the number of patients who had values at the noted visits. There were no subjects in the 10.0 mg/kg KHK4083 group in the LTE Therapy Period. There were no subjects in the 1.0 mg/kg KHK4083 group in the OLE Therapy Period. |
| Arm/Group Title | KHK4083 Cohort 1 | KHK4083 Cohort 2 | KHK4083 Cohorts 3 + 4 Combined | KHK4083 Combined | Placebo |
|---|---|---|---|---|---|
| Arm/Group 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. | The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy. | 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. |
| Measure Participants | 7 | 8 | 22 | 37 | 15 |
| LTE Period - Baseline Score |
8.0
(0.0)
|
7.8
(0.8)
|
7.9
(0.6)
|
7.5
(2.1)
|
|
| LTE Period - Week 52 Score |
2.5
(2.1)
|
2.5
(2.1)
|
|||
| LTE Period - Week 52 Change from Baseline |
-5.5
(2.1)
|
-5.5
(2.1)
|
|||
| OLE Period - Baseline Score |
7.6
(1.1)
|
7.8
(1.5)
|
7.8
(1.4)
|
7.6
(0.9)
|
|
| OLE Period - Week 52 Score |
3.7
(3.1)
|
3.6
(2.4)
|
3.6
(2.5)
|
4.3
(3.4)
|
|
| OLE Period - Week 52 Change from Baseline |
-4.0
(2.4)
|
-4.4
(2.7)
|
-4.3
(2.5)
|
-3.5
(2.8)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set - All randomized subjects who received at least one full dose of investigational product and had a Baseline and at least one post-treatment primary efficacy variable. |
| Arm/Group Title | KHK4083 Cohort 1 | KHK4083 Cohort 2 | KHK4083 Cohorts 3 + 4 Combined | KHK4083 Combined | Placebo |
|---|---|---|---|---|---|
| Arm/Group 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. | The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy. | 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. |
| Measure Participants | 7 | 8 | 22 | 37 | 15 |
| Count of Participants [Participants] |
3
33.3%
|
8
80%
|
11
122.2%
|
22
104.8%
|
9
52.9%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | KHK4083 Cohort 1 | KHK4083 Cohort 2 | KHK4083 Cohorts 3 + 4 Combined | KHK4083 Combined | Placebo |
|---|---|---|---|---|---|
| Arm/Group 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. | The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy. | 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. |
| Measure Participants | 7 | 8 | 21 | 36 | 14 |
| Count of Participants [Participants] |
2
22.2%
|
4
40%
|
14
155.6%
|
20
95.2%
|
5
29.4%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | KHK4083 Cohort 1 | KHK4083 Cohort 2 | KHK4083 Cohorts 3 + 4 Combined | KHK4083 Combined | Placebo |
|---|---|---|---|---|---|
| Arm/Group 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. | The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy. | 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. |
| Measure Participants | 7 | 8 | 22 | 37 | 15 |
| Count of Participants [Participants] |
1
11.1%
|
3
30%
|
6
66.7%
|
10
47.6%
|
3
17.6%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | KHK4083 Cohort 1 | KHK4083 Cohort 2 | KHK4083 Cohorts 3 + 4 Combined | KHK4083 Combined | Placebo |
|---|---|---|---|---|---|
| Arm/Group 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. | The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy. | 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. |
| Measure Participants | 7 | 8 | 21 | 36 | 14 |
| Count of Participants [Participants] |
1
11.1%
|
3
30%
|
6
66.7%
|
10
47.6%
|
5
29.4%
|
Adverse Events
| Time Frame | 52 Weeks | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||
| Arm/Group Title | KHK4083 Cohort 1 | KHK4083 Cohort 2 | KHK4083 Cohort 3 | KHK4083 Cohort 4 | KHK4083 Combined | Placebo | ||||||
| Arm/Group Description | Subjects who qualify will receive 1.0 mg/kg IV infusion treatments of KHK4083 from Baseline to Week 48. | Subjects who qualify will receive 3.0 mg/kg IV infusion treatments of KHK4083 from Baseline to Week 48. | Subjects who qualify will receive 10.0 mg/kg IV infusion treatments of KHK4083 from Baseline to Week 48. | Subjects who qualify will receive maximum tolerated dose (10.0 mg/kg) IV infusion treatments of KHK4083 from Baseline to Week 48. | The total number of participants analyzed who were randomized to KHK4083 during Treatment parts A & B. | Subjects received placebo IV infusion treatments from Baseline to Week 12. Subjects who completed double-blind Induction Therapy (i.e., at least five of six treatments) were eligible to enter OLE Therapy and receive 10 treatments of open-label KHK4083 (at the same dose administered to that subject during Induction Therapy) as maintenance therapy. Each subject was to receive one IV infusion every 4 weeks from Week 12 to Week 48. | ||||||
All Cause Mortality |
||||||||||||
| KHK4083 Cohort 1 | KHK4083 Cohort 2 | KHK4083 Cohort 3 | KHK4083 Cohort 4 | KHK4083 Combined | Placebo | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | 1/10 (10%) | 0/9 (0%) | 0/21 (0%) | 1/49 (2%) | 0/17 (0%) | ||||||
Serious Adverse Events |
||||||||||||
| KHK4083 Cohort 1 | KHK4083 Cohort 2 | KHK4083 Cohort 3 | KHK4083 Cohort 4 | KHK4083 Combined | Placebo | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/9 (11.1%) | 1/10 (10%) | 1/9 (11.1%) | 3/21 (14.3%) | 6/49 (12.2%) | 3/17 (17.6%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| Anaemia | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 0/49 (0%) | 0 | 1/17 (5.9%) | 2 |
| Cardiac disorders | ||||||||||||
| Myocardial infarction | 0/9 (0%) | 0 | 1/10 (10%) | 2 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 1/49 (2%) | 2 | 0/17 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||
| Colitis | 1/9 (11.1%) | 1 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 1/49 (2%) | 1 | 0/17 (0%) | 0 |
| Colitis ulcerative | 1/9 (11.1%) | 2 | 0/10 (0%) | 0 | 1/9 (11.1%) | 1 | 1/21 (4.8%) | 1 | 3/49 (6.1%) | 4 | 0/17 (0%) | 0 |
| Hepatobiliary disorders | ||||||||||||
| Hepatotoxicity | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 0/49 (0%) | 0 | 0/17 (0%) | 0 |
| Infections and infestations | ||||||||||||
| Clostridium difficile infection | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 1/21 (4.8%) | 1 | 1/49 (2%) | 1 | 1/17 (5.9%) | 1 |
| Pneumonia | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 1/21 (4.8%) | 1 | 1/49 (2%) | 1 | 0/17 (0%) | 0 |
| Post procedural infection | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 1/21 (4.8%) | 1 | 1/49 (2%) | 1 | 0/17 (0%) | 0 |
| Pyelonephritis | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 0/49 (0%) | 0 | 1/17 (5.9%) | 1 |
| Investigations | ||||||||||||
| Blood albumin decreased | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 1/21 (4.8%) | 1 | 1/49 (2%) | 1 | 0/17 (0%) | 0 |
| Surgical and medical procedures | ||||||||||||
| Abscess drainage | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 0/49 (0%) | 0 | 1/17 (5.9%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||||||||
| KHK4083 Cohort 1 | KHK4083 Cohort 2 | KHK4083 Cohort 3 | KHK4083 Cohort 4 | KHK4083 Combined | Placebo | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/9 (55.6%) | 7/10 (70%) | 7/9 (77.8%) | 13/21 (61.9%) | 32/49 (65.3%) | 13/17 (76.5%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| Anaemia | 2/9 (22.2%) | 2 | 2/10 (20%) | 2 | 0/9 (0%) | 0 | 3/21 (14.3%) | 3 | 7/49 (14.3%) | 7 | 3/17 (17.6%) | 4 |
| Lymphopenia | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 1/9 (11.1%) | 1 | 1/21 (4.8%) | 1 | 2/49 (4.1%) | 2 | 1/17 (5.9%) | 1 |
| Thrombocytosis | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 1/9 (11.1%) | 1 | 0/21 (0%) | 0 | 1/49 (2%) | 1 | 0/17 (0%) | 0 |
| Cardiac disorders | ||||||||||||
| Sinus bradycardia | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 1/9 (11.1%) | 1 | 0/21 (0%) | 0 | 0/49 (0%) | 0 | 0/17 (0%) | 0 |
| Congenital, familial and genetic disorders | ||||||||||||
| Renal aplasia | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 0/49 (0%) | 0 | 1/17 (5.9%) | 1 |
| Gastrointestinal disorders | ||||||||||||
| Abdominal distension | 0/9 (0%) | 0 | 1/10 (10%) | 1 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 0/49 (0%) | 0 | 0/17 (0%) | 0 |
| Abdominal pain | 0/9 (0%) | 0 | 3/10 (30%) | 3 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 3/49 (6.1%) | 3 | 1/17 (5.9%) | 1 |
| Abdominal pain lower | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 0/49 (0%) | 0 | 1/17 (5.9%) | 1 |
| Abdominal pain upper | 0/9 (0%) | 0 | 1/10 (10%) | 1 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 1/49 (2%) | 1 | 0/17 (0%) | 0 |
| Abdominal tenderness | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 0/49 (0%) | 0 | 1/17 (5.9%) | 1 |
| Colitis ulcerative | 1/9 (11.1%) | 1 | 1/10 (10%) | 1 | 1/9 (11.1%) | 1 | 2/21 (9.5%) | 2 | 5/49 (10.2%) | 5 | 5/17 (29.4%) | 5 |
| Diarrhoea | 0/9 (0%) | 0 | 1/10 (10%) | 2 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 1/49 (2%) | 2 | 0/17 (0%) | 0 |
| Flatulence | 0/9 (0%) | 0 | 1/10 (10%) | 1 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 1/49 (2%) | 1 | 0/17 (0%) | 0 |
| Gastrooesophageal reflux disease | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 0/49 (0%) | 0 | 1/17 (5.9%) | 1 |
| Haemorrhoidal haemorrhage | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 0/49 (0%) | 0 | 1/17 (5.9%) | 1 |
| Haemorrhoids | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 0/49 (0%) | 0 | 1/17 (5.9%) | 1 |
| Mouth ulceration | 1/9 (11.1%) | 1 | 0/10 (0%) | 0 | 1/9 (11.1%) | 1 | 0/21 (0%) | 0 | 2/49 (4.1%) | 2 | 0/17 (0%) | 0 |
| Mucous stools | 0/9 (0%) | 0 | 1/10 (10%) | 1 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 1/49 (2%) | 1 | 0/17 (0%) | 0 |
| Nausea | 0/9 (0%) | 0 | 1/10 (10%) | 1 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 1/49 (2%) | 1 | 1/17 (5.9%) | 1 |
| Vomiting | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 0/49 (0%) | 0 | 1/17 (5.9%) | 1 |
| General disorders | ||||||||||||
| Asthenia | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 1/9 (11.1%) | 1 | 0/21 (0%) | 0 | 1/49 (2%) | 1 | 0/17 (0%) | 0 |
| Chest discomfort | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 1/9 (11.1%) | 1 | 0/21 (0%) | 0 | 1/49 (2%) | 1 | 0/17 (0%) | 0 |
| Chills | 1/9 (11.1%) | 1 | 1/10 (10%) | 1 | 0/9 (0%) | 0 | 1/21 (4.8%) | 1 | 3/49 (6.1%) | 3 | 0/17 (0%) | 0 |
| Pyrexia | 3/9 (33.3%) | 3 | 1/10 (10%) | 1 | 1/9 (11.1%) | 1 | 1/21 (4.8%) | 1 | 6/49 (12.2%) | 6 | 0/17 (0%) | 0 |
| Hepatobiliary disorders | ||||||||||||
| Hepatic steatosis | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 0/49 (0%) | 0 | 1/17 (5.9%) | 1 |
| Infections and infestations | ||||||||||||
| Influenza | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 0/49 (0%) | 0 | 1/17 (5.9%) | 1 |
| Oral candidiasis | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 0/49 (0%) | 0 | 1/17 (5.9%) | 1 |
| Oral herpes | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 0/49 (0%) | 0 | 1/17 (5.9%) | 1 |
| Pharyngitis | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 1/21 (4.8%) | 1 | 1/49 (2%) | 1 | 1/17 (5.9%) | 1 |
| Sinusitis | 0/9 (0%) | 0 | 1/10 (10%) | 1 | 0/9 (0%) | 0 | 1/21 (4.8%) | 1 | 2/49 (4.1%) | 2 | 0/17 (0%) | 0 |
| Tonsillitis | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 0/49 (0%) | 0 | 1/17 (5.9%) | 1 |
| Urinary tract infection | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 1/21 (4.8%) | 1 | 1/49 (2%) | 1 | 1/17 (5.9%) | 1 |
| Viral upper respiratory tract infection | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 0/49 (0%) | 0 | 1/17 (5.9%) | 1 |
| Injury, poisoning and procedural complications | ||||||||||||
| Arthropod bite | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 0/49 (0%) | 0 | 1/17 (5.9%) | 1 |
| Scar | 1/9 (11.1%) | 1 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 1/49 (2%) | 1 | 0/17 (0%) | 0 |
| Investigations | ||||||||||||
| Alanine aminotransferase increased | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 0/49 (0%) | 0 | 1/17 (5.9%) | 1 |
| Amylase increased | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 0/49 (0%) | 0 | 1/17 (5.9%) | 1 |
| Aspartate aminotransferase abnormal | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 0/49 (0%) | 0 | 2/17 (11.8%) | 2 |
| Aspartate aminotransferase increased | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 0/49 (0%) | 0 | 2/17 (11.8%) | 2 |
| Blood creatine phosphokinase abnormal | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 0/49 (0%) | 0 | 1/17 (5.9%) | 1 |
| Blood creatine phosphokinase increased | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 1/9 (11.1%) | 1 | 1/21 (4.8%) | 2 | 2/49 (4.1%) | 3 | 1/17 (5.9%) | 1 |
| Blood folate decreased | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 1/9 (11.1%) | 1 | 0/21 (0%) | 0 | 1/49 (2%) | 1 | 0/17 (0%) | 0 |
| C-reactive protein increased | 1/9 (11.1%) | 1 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 1/49 (2%) | 1 | 0/17 (0%) | 0 |
| Lipase increased | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 0/49 (0%) | 0 | 1/17 (5.9%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Arthralgia | 2/9 (22.2%) | 2 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 1/21 (4.8%) | 1 | 3/49 (6.1%) | 3 | 1/17 (5.9%) | 1 |
| Joint swelling | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 1/9 (11.1%) | 1 | 0/21 (0%) | 0 | 1/49 (2%) | 1 | 0/17 (0%) | 0 |
| Muscular weakness | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 0/49 (0%) | 0 | 1/17 (5.9%) | 1 |
| Myalgia | 1/9 (11.1%) | 1 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 1/49 (2%) | 1 | 1/17 (5.9%) | 1 |
| Nervous system disorders | ||||||||||||
| Headache | 0/9 (0%) | 0 | 1/10 (10%) | 1 | 1/9 (11.1%) | 1 | 0/21 (0%) | 0 | 2/49 (4.1%) | 2 | 1/17 (5.9%) | 1 |
| Paraesthesia | 0/9 (0%) | 0 | 1/10 (10%) | 1 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 1/49 (2%) | 1 | 0/17 (0%) | 0 |
| Psychiatric disorders | ||||||||||||
| Anxiety | 0/9 (0%) | 0 | 1/10 (10%) | 1 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 1/49 (2%) | 1 | 0/17 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Cough | 0/9 (0%) | 0 | 0/10 (0%) | 0 | 1/9 (11.1%) | 1 | 0/21 (0%) | 0 | 1/49 (2%) | 1 | 0/17 (0%) | 0 |
| Oropharyageal pain | 1/9 (11.1%) | 1 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 1/49 (2%) | 1 | 0/17 (0%) | 0 |
| Sneezing | 0/9 (0%) | 0 | 1/10 (10%) | 1 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 1/49 (2%) | 1 | 0/17 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||
| Pruritis | 1/9 (11.1%) | 1 | 0/10 (0%) | 0 | 0/9 (0%) | 0 | 0/21 (0%) | 0 | 1/49 (2%) | 1 | 0/17 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Kyowa Kirin Pharmaceutical Development |
|---|---|
| Organization | Kyowa Kirin Pharmaceutical Development |
| Phone | 609-919-1100 |
| kkd.clintrial.82@kyowakirin.com |
Responsible Party:
Kyowa Kirin, Inc.
ClinicalTrials.gov Identifier:
NCT02647866
Other Study ID Numbers:
- 4083-002
First Posted:
Jan 6, 2016
Last Update Posted:
Mar 5, 2020
Last Verified:
Feb 1, 2020