A Study of E6011 in Participants With Active Crohn's Disease

NCT03733314 | Completed Phase 2 Results

• 3 other identifiers: E6011-ET22018-002109-70184139
• Study Type: interventional
• Target: 25
• Locations: 5 countries
• Sites: 46

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.

Conditions

Crohn's Disease

Keywords

Crohn's Disease; E6011; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal tract

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Clinical Response (CR) 100 (CR100) at Week 12

  CR100 was defined as clinical response with a reduction of greater than or equal to (\>=) 100 points in CDAI score from baseline. The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. The sub scores of abdominal pain (0-3), general well-being (0-4, higher values mean worse well-being), and number of very soft or liquid stools were then summed. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.

  At Week 12

Secondary Outcomes (16)

• Percentage of Participants With CR70 and CR100

  At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64

• Percentage of Participants With Below 150 CDAI Points

  At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64

• Percentage of Participants With at Least 5-point and 8-point Reduction From Baseline in Patient Reported Outcome 2 (PRO2)

  At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64

• Percentage of Participants With Below 8 Points in PRO2

  At Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64

• 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

  At Week 12

Study Arms (2)

E6011

EXPERIMENTAL

Drug: E6011

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

E6011 DRUG

E6011, infusion, intravenously.

E6011

Placebo DRUG

Placebo, infusion, intravenously.

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.
• 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.
• 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).
• 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.
• 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.
• 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.

You may not qualify if:

• Diagnosed with ulcerative colitis or indeterminate colitis.
• Diagnosed with gastrointestinal epithelial dysplasia.
• Who have an abscess or are suspected to have one.
• With an artificial anus, ileo-anal pouch or fistula.
• 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.).
• Who, after undergoing small bowel resection, have been diagnosed with a short bowel syndrome, which makes maintaining caloric intake difficult.

Sponsors & Collaborators

• EA Pharma Co., Ltd.: lead

Study Sites (46)

49, CCR Ostrava, s.r.o

Ostrava, Czechia

Location

15, University of Debrecen Clinical Centre

Debrecen, Hungary

Location

19, Semmelweis university

Győr, Hungary

Location

4

Nagoya, Aichi-ken, Japan

Location

17

Toyota, Aichi-ken, Japan

Location

10

Abiko, Chiba, Japan

Location

31

Kashiwa, Chiba, Japan

Location

27

Kitakyushu, Fukuoka, Japan

Location

39

Kitakyushu, Fukuoka, Japan

Location

29

Kasamatsuchō, Gifu, Japan

Location

41

Kure, Hiroshima, Japan

Location

38

Asahikawa, Hokkaido, Japan

Location

26

Sapporo, Hokkaido, Japan

Location

37

Kobe, Hyōgo, Japan

Location

7

Nishinomiya, Hyōgo, Japan

Location

32

Kanazawa, Ishikawa-ken, Japan

Location

8

Takamatsu, Kagawa-ken, Japan

Location

52

Isehara, Kanagawa, Japan

Location

30

Ōiso, Kanagawa, Japan

Location

28

Urasoe, Okinawa, Japan

Location

42

Hirakata, Osaka, Japan

Location

51

Hamamatsu, Shizuoka, Japan

Location

50

Shuntougun, Shizuoka, Japan

Location

2

Bunkyo, Tokyo, Japan

Location

33

Hachiōji, Tokyo, Japan

Location

34

Kodaira, Tokyo, Japan

Location

3

Minato, Tokyo, Japan

Location

6

Mitaka, Tokyo, Japan

Location

43

Shinagawa-Ku, Tokyo, Japan

Location

1

Shinjuku, Tokyo, Japan

Location

36

Akita, Japan

Location

25

Fukuoka, Japan

Location

35

Fukuoka, Japan

Location

11

Gifu, Japan

Location

5

Kagoshima, Japan

Location

40

Kanazawa, Japan

Location

24

Osaka, Japan

Location

21, Vitamed Galaj i Cichomski sp.j.

Bydgoszcz, Poland

Location

22, Vita Longa

Katowice, Poland

Location

20, Clinical Research Center sp. z o.o., Medic-R Sp. k.

Poznan, Poland

Location

23, Centrum Badań Klinicznych - Ośrodek Badań Wczesnej Fazy

Wroclaw, Poland

Location

45, Federal Siberian Research and Clinical Center

Krasnoyarsk, Russia

Location

44, LLC, Novosibirskiy Gastrocenter

Novosibirsk, Russia

Location

46, Pyatigorsk City Clinical Hospital

Pyatigorsk, Russia

Location

48, LLC Clinic, UZI 4D

Pyatigorsk, Russia

Location

47, City Hospital of Saint Martyr Elizaveth

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases; Gastroenteritis

Interventions

quetmolimab

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Corporate Communication Dept.
• Organization: EA Pharma Co., Ltd

contact_ea@eapharma.co.jp

+81-(0)3-6280-9600

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 7, 2018
• Study Start: April 25, 2019
• Primary Completion: March 16, 2022
• Study Completion: April 3, 2024
• Last Updated: April 2, 2025
• Results First Posted: April 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

RU (5); JP (34); CZ (1); PL (4); HU (2)