Clinical trial NCT03733314: A Study of E6011 in Participants With Active Crohn's Disease
Official title: Early Phase 2 Clinical Trial of E6011 in Patients With Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: Crohn's Disease
E6011
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal tract
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-07
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to examine the efficacy and safety of E6011 at 12 weeks after administration by means of double-blind placebo-controlled trial.

Detailed description: Participants with moderate to severe Crohn's disease will be enrolled in this study.

The study will include screening period, remission-induction period (double-blind), rescue period (open-label), extension period (open-label), post-observation period, and a follow-up period.

At the end of remission-induction period, participants with reduction in Crohn's disease activity index (CDAI) score of 70 points or more when compared to baseline will move on to the open-label extension period, and participants with less than 70 points reduction in CDAI score will move on to the rescue period. At the end of the rescue period, participants with a reduction in the CDAI of 70 points or more will move on to the open-label extension period and with less than 70 points reduction in the CDAI score will be discontinued.

The post-observation period will include in-person assessment after the completion or discontinuation of the extension period, and participants will be contacted by telephone, etc. after the last dose of study drug administration. Participants will be contacted over phone after the last dose of study drug administration for follow up assessments.

Eligibility criteria: Inclusion Criteria:

1. Has diagnosed on basis of clinical findings, endoscopic findings, etc. with small intestine-type, small and large-intestine type, or large-intestine type Crohn's disease at least 12 weeks before giving consent.
2. With a baseline (at week 0 before the start of investigational medicinal product \[IMP\] administration) disease severity ranging from moderate to severe. CDAI score between 220 and 450, and a PRO2 score between 14 and 34.
3. With a SES-CD \>=7 (or for participants with isolated ileal disease, \>=4 in ileum segment) in the screening period, with one or more ulcers (in SES-CD score, ulcer presence subscore \>=1 in any segment) assessed by colonoscopy and confirmed by a centralised review.
4. Who received adrenocorticosteroids or immunomodulators in the past, but showed no therapeutic response (insufficient response) or the drugs were not tolerated (intolerance). Alternatively, participants who cannot taper adrenocorticosteroids (dependence). Alternatively, participants who showed no therapeutic response after administering biologic(s) (primary nonresponse), participants who initially showed therapeutic response but it lessened or disappeared afterwards (secondary nonresponse), or participants who did not tolerate the drug (intolerance).
5. If the participants are taking aminosalicylic acid (5-ASA), salazosulfapyridine, or antibiotics for the treatment of Crohn's disease (metronidazole, ciprofloxacin, etc.), the dosage and administration have not changed for at least 4 weeks prior to the start of the IMP administration.
6. If the participants are taking under 30 milligram per day (mg/day) of oral prednisolone (or equivalent adrenocorticosteroid) or 9 mg/day or less of oral budesonide, the dosage and administration have not changed for at least 4 weeks prior to the start of the IMP administration.
7. If the participants are taking azathioprine (AZP), 6-mercaptopurine (6-MP) or methotrexate (MTX), the dosage and administration have not changed for at least 8 weeks prior to the start of the IMP administration.

Exclusion Criteria:

1. Diagnosed with ulcerative colitis or indeterminate colitis.
2. Diagnosed with gastrointestinal epithelial dysplasia.
3. Who have an abscess or are suspected to have one.
4. With an artificial anus, ileo-anal pouch or fistula.
5. With symptomatic or high-grade gastrointestinal stenosis (participants who require expansion by endoscopy or who require have SES-CD score stenosis sub-score of 3, etc.).
6. Who, after undergoing small bowel resection, have been diagnosed with a short bowel syndrome, which makes maintaining caloric intake difficult.

Primary outcomes:
measure: Percentage of Participants With Clinical Response (CR) 100 (CR100) at Week 12
timeFrame: At Week 12
Secondary outcomes:
measure: Percentage of Participants With CR70 and CR100
timeFrame: At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
measure: Percentage of Participants With Below 150 CDAI Points
timeFrame: At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
measure: Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2)
timeFrame: At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
measure: Percentage of Participants With Below 8 Points in PRO2
timeFrame: At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
measure: Percentage of Participants With at Least 50 Percent (%) Improvement in (Endoscopic Response) Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 12
timeFrame: At Week 12
measure: Percentage of Participants With Less Than or Equal to (<=) 2 (Endoscopic Remission) SES-CD Score at Week 12
timeFrame: At Week 12
measure: Change From Baseline in CDAI Score
timeFrame: Baseline, at Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
measure: Percent Change From Baseline in CDAI Score
timeFrame: Baseline, at Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
measure: Change From Baseline in PRO2
timeFrame: Baseline, at Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
measure: Percent Change From Baseline in PRO2
timeFrame: At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
measure: Change From Baseline in SES-CD Score at Week 12
timeFrame: Baseline, at Week 12
measure: Percent Change From Baseline in SES-CD Score at Week 12
timeFrame: Baseline, at Week 12
measure: Percentage of Participants Who Achieved Steroid-free Remission up to Week 64
timeFrame: Up to Week 64
measure: Percentage of Participants Who Achieved Steroid-free Improvement up to Week 64
timeFrame: Up to Week 64
measure: Change From Baseline in Steroid Dosage in Participants Concomitantly Using Adrenocorticosteroids up to Week 64
timeFrame: Baseline up to Week 64
measure: Percent Change From Baseline in Steroid Dosage in Participants Concomitantly Using Adrenocorticosteroids up to Week 64
timeFrame: Baseline up to Week 64
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: 49, CCR Ostrava, s.r.o
city: Debrecen
country: Hungary
facility: 15, University of Debrecen Clinical Centre
city: Győr
country: Hungary
facility: 19, Semmelweis university
city: Nagoya
country: Japan
facility: 4
state: Aichi
city: Toyota
country: Japan
facility: 17
state: Aichi
city: Abiko
country: Japan
facility: 10
state: Chiba
city: Kashiwa
country: Japan
facility: 31
state: Chiba
city: Kitakyushu
country: Japan
facility: 27
state: Fukuoka
city: Kitakyushu
country: Japan
facility: 39
state: Fukuoka
city: Kasamatsu
country: Japan
facility: 29
state: Gifu
city: Kure
country: Japan
facility: 41
state: Hiroshima
city: Asahikawa
country: Japan
facility: 38
state: Hokkaido
city: Sapporo
country: Japan
facility: 26
state: Hokkaido
city: Kobe
country: Japan
facility: 37
state: Hyogo
city: Nishinomiya
country: Japan
facility: 7
state: Hyogo
city: Kanazawa
country: Japan
facility: 32
state: Ishikawa
city: Takamatsu
country: Japan
facility: 8
state: Kagawa
city: Isehara
country: Japan
facility: 52
state: Kanagawa
city: Ōiso
country: Japan
facility: 30
state: Kanagawa
city: Urasoe
country: Japan
facility: 28
state: Okinawa
city: Hirakata
country: Japan
facility: 42
state: Osaka
city: Hamamatsu
country: Japan
facility: 51
state: Shizuoka
city: Shuntougun
country: Japan
facility: 50
state: Shizuoka
city: Bunkyo
country: Japan
facility: 2
state: Tokyo
city: Hachiōji
country: Japan
facility: 33
state: Tokyo
city: Kodaira
country: Japan
facility: 34
state: Tokyo
city: Minato
country: Japan
facility: 3
state: Tokyo
city: Mitaka
country: Japan
facility: 6
state: Tokyo
city: Shinagawa-Ku
country: Japan
facility: 43
state: Tokyo
city: Shinjuku
country: Japan
facility: 1
state: Tokyo
city: Akita
country: Japan
facility: 36
city: Fukuoka
country: Japan
facility: 25
city: Fukuoka
country: Japan
facility: 35
city: Gifu
country: Japan
facility: 11
city: Kagoshima
country: Japan
facility: 5
city: Kanazawa
country: Japan
facility: 40
city: Osaka
country: Japan
facility: 24
city: Bydgoszcz
country: Poland
facility: 21, Vitamed Galaj i Cichomski sp.j.
city: Katowice
country: Poland
facility: 22, Vita Longa
city: Poznań
country: Poland
facility: 20, Clinical Research Center sp. z o.o., Medic-R Sp. k.
city: Wrocław
country: Poland
facility: 23, Centrum Badań Klinicznych - Ośrodek Badań Wczesnej Fazy
city: Krasnoyarsk
country: Russian Federation
facility: 45, Federal Siberian Research and Clinical Center
city: Novosibirsk
country: Russian Federation
facility: 44, LLC, Novosibirskiy Gastrocenter
city: Pyatigorsk
country: Russian Federation
facility: 46, Pyatigorsk City Clinical Hospital
city: Pyatigorsk
country: Russian Federation
facility: 48, LLC Clinic, UZI 4D
city: Saint Petersburg
country: Russian Federation
facility: 47, City Hospital of Saint Martyr Elizaveth
Study officials:
References: