A Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's Disease

NCT02039063 | Completed Phase 1 Results

• 2 other identifiers: E6011-J081-101142543
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 17

Brief 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.

Conditions

Crohn's Disease

Keywords

Crohn's Disease

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  Baseline up to Week 52

• Number of Participants With Neurological Findings

  Number of participants with neurological findings were reported.

  Baseline up to Week 52

Secondary Outcomes (2)

• Mean Trough Serum Concentration of E6011 at Week 12 and 52

  Week 12: Pre-dose; Week 52: Pre-dose

• Number of Participants With Serum Anti-E6011 Antibody at Week 12 and 52

  At Week 12 and Week 52

Study Arms (4)

1

EXPERIMENTAL

E6011 2 mg/kg

Drug: E6011 2 mg/kg

2

EXPERIMENTAL

E6011 5 mg/kg

Drug: E6011 5 mg/kg

3

EXPERIMENTAL

E6011 10 mg/kg

Drug: E6011 10 mg/kg

4

EXPERIMENTAL

E6011 15 mg/kg

Drug: E6011 15 mg/kg

Interventions

E6011 2 mg/kg DRUG

1

E6011 5 mg/kg DRUG

2

E6011 10 mg/kg DRUG

3

E6011 15 mg/kg DRUG

4

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must meet all of the following criteria to be included in this study:
• Japanese patients aged 20 to 64 years old at the time of informed consent.
• Diagnosed with Crohn's disease based on the diagnostic criteria for Crohn's disease of the Health and Labor Sciences Research Grants "Research on Measures against Intractable Diseases (Inflammatory Bowel Disease)" Group (2012).
• Mild to moderate severity at Observation Phase (CDAI between 150 and 450, based on the above diagnosis criteria for Crohn's disease).
• History of aminosalycylic acid (5-ASA), salazosulfapyridine, cortical steroid, immunomodulators, infliximab or adalimumab treatment with no apparent effect, or unable to continue the treatment due to AEs (except for infliximab and adalimumab).
• Consent to use contraception (both the subject and the subject's partner), if the subject is a a man capable of reproduction or a woman of childbearing potential.
• Has voluntarily consented, in writing, to participate in this study.
• Has been thoroughly briefed on the conditions for participation in the study, and is willing and able to comply with the conditions.

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from this study:
• Abscess or suspected abscess found at Screening or Observation Phase (not applicable to perianal abscess).
• Diagnosed with gastrointestinal epithelia dysplasia at Screening or Observation Phase.
• Suspected of colitis other than Crohn's disease at Screening or Observation Phase (such as pseudomembranous colitis).
• Symptomatic obstruction at Screening or Observation Phase.
• Underwent intestinal resection within 24 weeks before the start of the study treatment, or planning to undergo intestinal resection in the next 52 weeks.
• Newly started with Seaton drainage within 12 weeks before Observation Phase.
• Diagnosed with short bowel syndrome at Screening or Observation Phase.
• Positive C.Difficile toxin test at Screening.
• Prior history or current complication of malignant tumor, lymphoma, leukemia, or lymphoproliferative disease.
• Immunodeficiency or history of HIV infection.
• Infection requiring hospitalization or intravenous administration of antibiotics within 4 weeks before the start of the study treatment; or an infection requiring oral antibiotics within 2 weeks before the start of the study treatment.
• History of tuberculosis or current complication of active tuberculosis.
• History of serious allergy (shock, or anaphylactoid symptoms).
• History of clinically important vascular edema, hematemesis, or hemoptysis.

Sponsors & Collaborators

• EA Pharma Co., Ltd.: lead

Study Sites (17)

Unknown Facility

Nagoya, Aichi-ken, Japan

Location

Unknown Facility

Chikushino-shi, Fukuoka, Japan

Location

Unknown Facility

Kurume, Fukuoka, Japan

Location

Unknown Facility

Asahikawa, Hokkaido, Japan

Location

Unknown Facility

Nishinomiya, Hyōgo, Japan

Location

Unknown Facility

Kanazawa, Ishikawa-ken, Japan

Location

Unknown Facility

Morioka, Iwate, Japan

Location

Unknown Facility

Sagamihara, Kanagawa, Japan

Location

Unknown Facility

Tsu, Mie-ken, Japan

Location

Unknown Facility

Urazoe, Okinawa, Japan

Location

Unknown Facility

Takatsuki, Osaka, Japan

Location

Unknown Facility

Minato-ku, Tokyo, Japan

Location

Unknown Facility

Shinjuku-ku, Tokyo, Japan

Location

Unknown Facility

Chiba, Japan

Location

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Kyoto, Japan

Location

Unknown Facility

Osaka, Japan

Location

Related Publications (1)

• Matsuoka K, Naganuma M, Hibi T, Tsubouchi H, Oketani K, Katsurabara T, Hojo S, Takenaka O, Kawano T, Imai T, Kanai T. Phase 1 study on the safety and efficacy of E6011, antifractalkine antibody, in patients with Crohn's disease. J Gastroenterol Hepatol. 2021 Aug;36(8):2180-2186. doi: 10.1111/jgh.15463. Epub 2021 Mar 31.

  PMID: 33599356 RESULT

MeSH Terms

Conditions

Crohn Disease

Interventions

quetmolimab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; 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: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2014
• First Posted: January 17, 2014
• Study Start: April 5, 2014
• Primary Completion: January 6, 2017
• Study Completion: November 27, 2017
• Last Updated: January 30, 2023
• Results First Posted: January 30, 2023

Record last verified: 2019-01

Locations

JP (17)