A Phase 1/2 interventional study of E6011 2 mg/kg and E6011 5 mg/kg in Crohn's Disease, sponsored by EA Pharma Co., Ltd.. Completed at 17 sites in Japan. Open to participants aged 20 Years to 64 Years. Per ClinicalTrials.gov, last updated 2023-01-30.
Sponsored by EA Pharma Co., Ltd. (part of Eisai Co., Ltd.) · Phase 1/2, Interventional, and Treatment
This study is a multicenter, open-label, uncontrolled, multiple ascending dose (MAD) study to evaluate mainly the safety and tolerability of 12-week repeated intravenous administration of E6011. A total of 24 subjects will enroll into four cohorts. Six subjects per cohort will receive repeated intravenous administration of E6011.
This study consists of Screening Phase, Observation Phase, Treatment Phase, Extension Phase, and Follow-up Phase. Screening assessments will be performed between 42 to 2 days before study drug administration. Observation Phase assessments will be performed a day before or on a day of the initial administration to confirm the eligibility of subjects. The eligible subjects will receive the repeated intravenous administration of E6011. E6011 will be dissolved in physiological saline (nearly 100 mL) for approximately 30-minute infusion. During the Treatment Phase, for the first and second cohorts, E6011 will be administered every 2 weeks up to Week 10, a total of 6 times (with a double dose at Week 0). For the third and fourth cohorts, E6011 will be administered at Weeks 0, 1 and 2, then every 2 weeks up to Week 10, a total of 7 times. Under no safety concerns, Crohn's Disease Activity (CDAI) is less than 150 or a decrease in CDAI from the Observation Phase is greater than 70 and a subject intends to continue administrations, the subject will receive a total of 20 subsequent biweekly administrations (40 weeks) at stable dose (Extension Phase). Subjects will be hospitalized for 24 hours after the initial and second administrations for postdose monitoring and will have out-patient monitoring until 12 weeks after the initial administration. If hospitalization is difficult after the second administration, the subjects can be held at the hospital for 6 hours and then allowed to go home after confirmation of the safety. Subjects who roll over onto the Extension Phase will have continued monitoring until 52 weeks after the initial administration. When the subjects complete (Week 12 or Week 52) or discontinue the study, they will undergo an on-site follow-up 28 days after the study completion or discontinuation and an off-site follow-up or telephone interview 70 days after the final administration. The investigator will conduct full assessments of subjects safety next day of the second administration (24 hours after the second administration) to confirm presence of absence of study-related manifestations which may affect the study drug administration of next cohort. When the sponsor is informed of investigator's judgment on the sixth subject in each cohort, the appropriateness of next cohort will be judged based on the safety data available including the judgment of individual investigator on the next day of the second administration.
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's enrollment of 28 is below the median of 67 across 1,260 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →EA Pharma Co., Ltd. is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects must meet all of the following criteria to be included in this study:
Exclusion Criteria
Subjects who meet any of the following criteria will be excluded from this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
E6011 2 mg/kg
Drug: E6011 2 mg/kg
E6011 5 mg/kg
Drug: E6011 5 mg/kg
E6011 10 mg/kg
Drug: E6011 10 mg/kg
E6011 15 mg/kg
Drug: E6011 15 mg/kg
Drug page: Quetmolimab
Drug page: Quetmolimab
Drug page: Quetmolimab
Drug page: Quetmolimab
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs was defined as adverse event (AEs) that emerged during the treatment, having been absent at pretreatment (Baseline) or re-emerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. An AE was defined as any untoward medical occurrence in a participants or clinical study participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. A SAE was defined as any untoward medical occurrence at any dose if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect.
Time frame: Baseline up to Week 62 (70 days after last dose of study drug)
Number of Participants With Clinically Significant Change in Laboratory Parameters
Clinical laboratory parameters included biochemistry, hematology, urinalysis and other screening test. Number of participants with clinically significant abnormalities in laboratory parameters which were deemed clinically significant by the investigator were reported.
Time frame: Baseline up to Week 52
Number of Participants With Clinically Significant Change in Vital Sign Measurements
Vital sign measurements included blood pressure (systolic and diastolic blood pressure) and pulse rate. Number of participants with clinically significant change in vital signs measurements which were deemed clinically significant by the investigator were reported.
Time frame: Baseline up to Week 52
Number of Participants With Treatment-emergent Clinically Significant Abnormal Electrocardiogram (ECG) Findings
Number of participants with treatment-emergent clinically significant abnormal ECG findings which were deemed clinically significant by the investigator were reported.
Time frame: Baseline up to Week 52
Number of Participants With Abnormal Chest X-ray Findings
Number of participants with abnormal chest X-ray findings were reported.
Time frame: Baseline up to Week 52
Number of Participants With Neurological Findings
Number of participants with neurological findings were reported.
Time frame: Baseline up to Week 52
Mean Trough Serum Concentration of E6011 at Week 12 and 52
Time frame: Week 12: Pre-dose; Week 52: Pre-dose
Number of Participants With Serum Anti-E6011 Antibody at Week 12 and 52
Number of participants with serum anti-E6011 antibody were reported.
Time frame: At Week 12 and Week 52
Participants took part in the study at 22 investigative sites in Japan from 05 April 2014 to 27 November 2017.
| Milestone | Cohort 1: E6011 2 mg/kg | Cohort 2: E6011 5 mg/kg | Cohort 3: E6011 10 mg/kg | Cohort 4: E6011 15 mg/kg |
|---|---|---|---|---|
| Started | 6 | 8 | 7 | 7 |
| Completed | 3 | 6 | 5 | 5 |
| Not completed | 3 | 2 | 2 | 2 |
| Withdrew: Inadequate therapeutic effect | 3 | 2 | 1 | 1 |
| Withdrew: Progression of disease | 0 | 0 | 1 | 1 |
| Milestone | Cohort 1: E6011 2 mg/kg | Cohort 2: E6011 5 mg/kg | Cohort 3: E6011 10 mg/kg | Cohort 4: E6011 15 mg/kg |
|---|---|---|---|---|
| Started | 1 | 3 | 5 | 3 |
| Completed | 1 | 2 | 2 | 2 |
| Not completed | 0 | 1 | 3 | 1 |
| Withdrew: Inadequate therapeutic effect | 0 | 1 | 2 | 0 |
| Withdrew: Progression of disease | 0 | 0 | 0 | 1 |
| Withdrew: Adverse event | 0 | 0 | 1 | 0 |
TEAEs was defined as adverse event (AEs) that emerged during the treatment, having been absent at pretreatment (Baseline) or re-emerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. An AE was defined as any untoward medical occurrence in a participants or clinical study participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. A SAE was defined as any untoward medical occurrence at any dose if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect.
| Participants | Cohort 1: E6011 2 mg/kg | Cohort 2: E6011 5 mg/kg | Cohort 3: E6011 10 mg/kg | Cohort 4: E6011 15 mg/kg |
|---|---|---|---|---|
| TEAE | 6 | 6 | 7 | 3 |
| SAE | 1 | 1 | 5 | 0 |
Clinical laboratory parameters included biochemistry, hematology, urinalysis and other screening test. Number of participants with clinically significant abnormalities in laboratory parameters which were deemed clinically significant by the investigator were reported.
| Participants | Cohort 1: E6011 2 mg/kg | Cohort 2: E6011 5 mg/kg | Cohort 3: E6011 10 mg/kg | Cohort 4: E6011 15 mg/kg |
|---|---|---|---|---|
| Number of Participants With Clinically Significant Change in Laboratory Parameters | 0 | 0 | 0 | 0 |
Vital sign measurements included blood pressure (systolic and diastolic blood pressure) and pulse rate. Number of participants with clinically significant change in vital signs measurements which were deemed clinically significant by the investigator were reported.
| Participants | Cohort 1: E6011 2 mg/kg | Cohort 2: E6011 5 mg/kg | Cohort 3: E6011 10 mg/kg | Cohort 4: E6011 15 mg/kg |
|---|---|---|---|---|
| Number of Participants With Clinically Significant Change in Vital Sign Measurements | 0 | 0 | 0 | 0 |
Number of participants with treatment-emergent clinically significant abnormal ECG findings which were deemed clinically significant by the investigator were reported.
| Participants | Cohort 1: E6011 2 mg/kg | Cohort 2: E6011 5 mg/kg | Cohort 3: E6011 10 mg/kg | Cohort 4: E6011 15 mg/kg |
|---|---|---|---|---|
| Number of Participants With Treatment-emergent Clinically Significant Abnormal Electrocardiogram (ECG) Findings | 0 | 0 | 0 | 0 |
Number of participants with abnormal chest X-ray findings were reported.
| Participants | Cohort 1: E6011 2 mg/kg | Cohort 2: E6011 5 mg/kg | Cohort 3: E6011 10 mg/kg | Cohort 4: E6011 15 mg/kg |
|---|---|---|---|---|
| Number of Participants With Abnormal Chest X-ray Findings | 0 | 0 | 0 | 0 |
Number of participants with neurological findings were reported.
| Participants | Cohort 1: E6011 2 mg/kg | Cohort 2: E6011 5 mg/kg | Cohort 3: E6011 10 mg/kg | Cohort 4: E6011 15 mg/kg |
|---|---|---|---|---|
| Number of Participants With Neurological Findings | 0 | 0 | 0 | 0 |
| microgram per milliliter (mcg/mL) | Cohort 1: E6011 2 mg/kg | Cohort 2: E6011 5 mg/kg | Cohort 3: E6011 10 mg/kg | Cohort 4: E6011 15 mg/kg |
|---|---|---|---|---|
| Week 12 | 3.40 ± 3.74 | 26.1 ± 10.4 | 96.8 ± 60.3 | 146 ± 91.9 |
| Week 52 | 10.8 ± NA | 17.3 ± 2.90 | 105 ± 9.69 | 93.9 ± 46.8 |
Number of participants with serum anti-E6011 antibody were reported.
| Participants | Cohort 1: E6011 2 mg/kg | Cohort 2: E6011 5 mg/kg | Cohort 3: E6011 10 mg/kg | Cohort 4: E6011 15 mg/kg |
|---|---|---|---|---|
| Week 12 | 4 | 3 | 2 | 1 |
| Week 52 | 4 | 3 | 2 | 1 |
Collected over Baseline up to Week 62 (70 days after last dose of study drug). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1: E6011 2 mg/kg | 0/6 (0%) | 1/6 (16.7%) | 6/6 (100%) |
| Cohort 2: E6011 5 mg/kg | 0/8 (0%) | 1/8 (12.5%) | 6/8 (75%) |
| Cohort 3: E6011 10 mg/kg | 0/7 (0%) | 5/7 (71.4%) | 7/7 (100%) |
| Cohort 4: E6011 15 mg/kg | 0/7 (0%) | 0/7 (0%) | 3/7 (42.9%) |
| Event | Cohort 1: E6011 2 mg/kg | Cohort 2: E6011 5 mg/kg | Cohort 3: E6011 10 mg/kg | Cohort 4: E6011 15 mg/kg |
|---|---|---|---|---|
| Crohn's diseaseGastrointestinal disorders | 0/6 | 1/8 | 4/7 | 0/7 |
| Miscarriage of partnerSocial circumstances | 1/6 | 0/8 | 0/7 | 0/7 |
| AnaemiaBlood and lymphatic system disorders | 0/6 | 0/8 | 1/7 | 0/7 |
| Event | Cohort 1: E6011 2 mg/kg | Cohort 2: E6011 5 mg/kg | Cohort 3: E6011 10 mg/kg | Cohort 4: E6011 15 mg/kg |
|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 1/6 | 4/8 | 2/7 | 0/7 |
| PyrexiaGeneral disorders | 2/6 | 0/8 | 0/7 | 0/7 |
| HeadacheNervous system disorders | 2/6 | 0/8 | 1/7 | 1/7 |
| Device related infectionInfections and infestations | 0/6 | 0/8 | 2/7 | 0/7 |
| NauseaGastrointestinal disorders | 1/6 | 0/8 | 1/7 | 0/7 |
| MalaiseGeneral disorders | 1/6 | 0/8 | 0/7 | 0/7 |
| Anal abscessInfections and infestations | 1/6 | 1/8 | 0/7 | 0/7 |
| InfluenzaInfections and infestations | 1/6 | 0/8 | 0/7 | 0/7 |
| PharyngitisInfections and infestations | 1/6 | 0/8 | 0/7 | 0/7 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/6 | 0/8 | 0/7 | 0/7 |
The safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
| Age, Continuous(years) | Cohort 1: E6011 2 mg/kg | Cohort 2: E6011 5 mg/kg | Cohort 3: E6011 10 mg/kg | Cohort 4: E6011 15 mg/kg | Total |
|---|---|---|---|---|---|
| Mean | 31.0 ± 7.35 | 38.1 ± 12.33 | 39.9 ± 14.79 | 37.0 ± 8.16 | 36.8 ± 11.10 |
| Sex: Female, Male(Participants) | Cohort 1: E6011 2 mg/kg | Cohort 2: E6011 5 mg/kg | Cohort 3: E6011 10 mg/kg | Cohort 4: E6011 15 mg/kg | Total |
|---|---|---|---|---|---|
| Female | 1 | 1 | 2 | 3 | 7 |
| Male | 5 | 7 | 5 | 4 | 21 |
| Race/Ethnicity, Customized(Participants) | Cohort 1: E6011 2 mg/kg | Cohort 2: E6011 5 mg/kg | Cohort 3: E6011 10 mg/kg | Cohort 4: E6011 15 mg/kg | Total |
|---|---|---|---|---|---|
| Japanese | 6 | 8 | 7 | 7 | 28 |
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Quetmolimab