Ulcerative ColitisPhase 2NCT02647866
Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis
A Phase 2 study testing KHK4083 in people with Ulcerative Colitis and Digestive System Diseases, run by Kyowa Kirin, Inc. at 23 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Digestive System Diseases, Colitis, Ulcerative
- What is being tested?
- KHK4083
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 23 sitesin 7 countries
- Study dates
- Jun 2016to Oct 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 36Show fewer
- 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.
Trial locations and contacts
23 sites in 7 countries.
23 sites in 7 countries
Poland7 sites
Study site
Bydgoszcz, 85-168
Study site
Rzeszów, 35-302
Study site
Sopot, 81-756
Study site
Tychy, 43-100
Study site
Warsaw, 00-632
Study site
Warsaw, 03-580
Study site
Warsaw, 54-239
Russia6 sites
Study site
Krasnoyarsk, 660022
Study site
Moscow, 129110
Study site
Novosibirsk, 630091
Study site
Penza, 440026
Study site
Saint Petersburg, 194354
Study site
Saint Petersburg, 196247
Hungary3 sites
Study site
Budapest, 1125
Study site
Budapest, H-1032
Study site
Budapest, H-1083
Serbia3 sites
Bežanija Kosa
Belgrade, 11080
Study site
Kragujevac, 34 000
Study site
Zemun, Belgrade, 11080
About this study
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
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.
Read the 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.
- Conditions
- Ulcerative Colitis, Digestive System Diseases, Colitis, Ulcerative, Colitis, Gastrointestinal Diseases, Inflammatory Bowel Diseases
- Being tested
- KHK4083, Placebo
- Keywords
- 4083-002, Intestinal Diseases, Ulcerative Colitis, UC, Mayo Clinic Scoring, Gastrointestinal Tract
- Medical subject headings
- Colitis, Ulcerative, Digestive System Diseases, Colitis, Gastrointestinal Diseases, Inflammatory Bowel Diseases, Intestinal Diseases, Colonic Diseases, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KHK4083Drug
IV Infusion
PlaceboDrug
IV Infusion
| Study group | Role | What they receive |
|---|---|---|
| KHK4083 Cohort 1 | Experimental | 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. Receives: Drug: KHK4083 |
| KHK4083 Cohort 2 | Experimental | 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. Receives: Drug: KHK4083 |
| KHK4083 Cohort 3 | Experimental | 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. Receives: Drug: KHK4083 |
| KHK4083 Cohort 4 | Experimental | 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. Receives: Drug: KHK4083 |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Treatment-related Adverse Events
To determine the safety and tolerability of KHK4083
Measured: Up to 52 weeks
Number of Subjects With Treatment-related Serious Adverse Events
To determine the safety and tolerability of KHK4083
Measured: Up to 52 weeks
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.
Measured: 12 weeks
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.
Measured: 52 weeks
Secondary outcomes (9)
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.
Measured: 52 weeks
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.
Measured: 12 weeks
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.
Measured: 52 weeks
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.
Measured: 12 weeks
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.
Measured: 52 weeks
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.
Measured: 12 weeks
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.
Measured: 52 weeks
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.
Measured: 12 weeks
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.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vincent Strout, MBA, Study director, Kyowa Kirin, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647866
- Sponsor's protocol ID
- 4083-002
- Status last verified
- Apr 2024
- First submitted
- 8 Dec 2015
- Last updated
- 26 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02647866
- Acronym / sponsor ID
- 4083-002
- Conditions
- Ulcerative Colitis, Digestive System Diseases, Colitis, Ulcerative, Colitis, Gastrointestinal Diseases, Inflammatory Bowel Diseases
- Keywords
- 4083-002, Intestinal Diseases, Ulcerative Colitis, UC, Mayo Clinic Scoring, Gastrointestinal Tract
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Kyowa Kirin, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 6 Jan 2016 (estimated)
- Results
- Posted 5 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- 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).
| Arm | Type | Receives |
|---|---|---|
| KHK4083 Cohort 1 | Experimental | Drug: KHK4083Subjects 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. |
| KHK4083 Cohort 2 | Experimental | Drug: KHK4083Subjects 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. |
| KHK4083 Cohort 3 | Experimental | Drug: KHK4083Subjects 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. |
| KHK4083 Cohort 4 | Experimental | Drug: KHK4083Subjects 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. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (36 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KHK4083IV Infusion | Drug | KHK4083 Cohort 1, KHK4083 Cohort 2, KHK4083 Cohort 3, KHK4083 Cohort 4 |
| PlaceboIV Infusion | Drug | Placebo |
Primary outcome
Number of Subjects With Treatment-related Adverse Events
Time frame: Up to 52 weeks
To determine the safety and tolerability of KHK4083
Number of Subjects With Treatment-related Serious Adverse Events
Time frame: Up to 52 weeks
To determine the safety and tolerability of KHK4083
Number of Subjects Who Show Improvement in the Mucosa at Week 12
Time frame: 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
Time frame: 52 weeks
Measured by the modified Mayo endoscopy sub-score (mMES), which ranges from 0-3 with higher scores = more severe disease.
9 secondary outcomes
Number of Subjects With Confirmed Anti-KHK4083 Antibodies (Immunogenicity)
Time frame: 52 weeks
Number of Subjects Who Achieve Mucosal Healing at Week 12
Time frame: 12 weeks
Number of Subjects Who Achieve Mucosal Healing at Week 52
Time frame: 52 weeks
Number of Subjects Who Achieve Clinical Improvement at Week 12
Time frame: 12 weeks
Change From Baseline in Total Mayo Scale Score at Week 52
Time frame: 52 weeks
Number of Subjects Who Achieve a Clinical Response at Week 12
Time frame: 12 weeks
Number of Subjects Who Achieve a Clinical Response at Week 52
Time frame: 52 weeks
Number of Subjects Who Achieve Clinical Remission at Week 12
Time frame: 12 weeks
Number of Subjects Who Achieve Clinical Remission at Week 52
Time frame: 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Strout, MBA study director
Kyowa Kirin, Inc.
23 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KHK4083 in people with Ulcerative Colitis and Digestive System Diseases, run by Kyowa Kirin, Inc. at 23 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Poland, Russia, Hungary, Serbia, Czechia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Treatment-related Adverse Events (time frame: Up to 52 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.