A Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): E6011 2 mg/kg; E6011 5 mg/kg; E6011 10 mg/kg; E6011 15 mg/kg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Quetmolimab; Antibodies, Monoclonal
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: Crohn's Disease