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Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis

Primary Purpose

Crohn Disease, Ulcerative Colitis

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

MDGN-002

About this trial

This is an interventional treatment trial for Crohn Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject is male or female, ≥ 18 to ≤ 75 years of age.
Subject has a documented diagnosis of CD via endoscopy/colonoscopy and histological confirmation, or subject has received a diagnosis of UC for 90 days or greater prior to Visit 1, confirmed by endoscopy during the Screening Period, with exclusion of current infection, dysplasia and/or malignancy.
Subject has moderate to severe, active CD as evidenced Simple Endoscopy Score for Crohn's Disease (SES-CD) score of ≥7, and histological confirmation, or subject has moderately to severely active UC, as defined by a Modified Mayo Score (excluding the PGA component) of 5 to 9 points at Visit 1.
Subject has failed treatment with an approved therapeutic dose of an anti-TNFα monoclonal antibody treatment.

Exclusion Criteria:

Subject has a diagnosis of ulcerative colitis (UC) or indeterminate colitis or subject has a diagnosis of Crohn's disease or indeterminate colitis .
Subject with signs or symptoms of bowel obstruction.
Subject has short bowel syndrome.
Subject has a current functional colostomy or ileostomy.
Subject has had a surgical bowel resection within the past 6 months prior to screening or is planning any resection during the study period.
Subject is pregnant or a nursing mother.
Subject is sexually active and not using effective contraception as defined in the protocol.

Sites / Locations

Sweet Hope Research Specialty, Inc.
Advanced Research Institute, Inc.
Egleston Hospital
University of Kansas Medical Center
University of Louisville
Hassman Research Institute
University of Cincinnati
Penn Presbyterian Medical Center
The Center for Pediatric Inflammatory Bowel Disease, Children's Hospital of Philadelphia
Vanderbilt University Medical Center
The University of Texas Health Science Center at Houston
Clinical Associates in Research Therapeutics of America, LLC
Care Access Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MDGN-002

Arm Description

MDGN-002 will be supplied in vials of 150 mg/mL. MDGN-002 will be administered by SQ injection in the abdomen every 14 days at 1 of 2 dose levels: 1.0 mg/kg or 3.0 mg/kg.

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Incidence of Vital Signs Findings [Safety and Tolerability]

Incidence of Electrocardiogram (ECG) Findings [Safety and Tolerability]

Incidence of Clinical Laboratory Tests Findings [Safety and Tolerability]

Secondary Outcome Measures

MDGN-002 Plasma Concentration

Change from baseline in Simple Endoscopy Score for Crohn's Disease (SES-CD)

The SES-CD total score, ranging from 0-60, is calculated as the sum of all variable total scores with a higher score indicating more severe endoscopic activity.

Change from baseline in Crohn's Disease Activity Index (CDAI)

The total CDAI score can range from 0 to approximately 600 with higher scores indicating more active disease.

Change from baseline in Inflammatory Bowel Disease Questionnaire (IBD-Q).

The IBD-Q is a 32-item questionnaire scored on a 1 to 7 scale, where higher scores represent a more positive response.

Change from baseline in abdominal pain and loose/watery stool frequency

Abdominal pain will be assessed on a scale of 0 to 3 with higher values indicating greater pain severity. The stool frequency including number of loose and/or watery stools per day, equivalent to a score of a 6 or 7 on the Bristol Stool Scale, will be recorded.

Change from baseline in Modified Mayo Endoscopic Score

The Modified Mayo Endoscopic Score can range from 0 to 3, with higher scores indicating more severe disease.

Full Information

NCT ID

NCT03169894

First Posted

May 24, 2017

Last Updated

February 24, 2022

Sponsor

Aevi Genomic Medicine, LLC, a Cerecor company

1. Study Identification

Unique Protocol Identification Number

NCT03169894

Brief Title

Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis

Official Title

Phase Ib Escalating Dose, Open-Label, Signal-Finding Study to Evaluate the Safety, Tolerability, and Short-Term Efficacy of the Anti-Light Monoclonal Antibody MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis Who Previously Failed Treatment With an Anti-TNFα Agent

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Terminated

Why Stopped

Strategic reasons

Study Start Date

July 14, 2017 (Actual)

Primary Completion Date

September 14, 2021 (Actual)

Study Completion Date

October 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aevi Genomic Medicine, LLC, a Cerecor company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a Phase 1b, open-label, dose-escalation, signal-finding, multi-center study. The study will evaluate the safety, tolerability, pharmacokinetics and short-term efficacy of MDGN-002 in adults with moderate to severe, active Crohn's disease or Ulcerative Colitis who have previously failed anti-tumor necrosis factor alpha (anti-TNFα) treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn Disease, Ulcerative Colitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MDGN-002

Arm Type

Experimental

Arm Description

MDGN-002 will be supplied in vials of 150 mg/mL. MDGN-002 will be administered by SQ injection in the abdomen every 14 days at 1 of 2 dose levels: 1.0 mg/kg or 3.0 mg/kg.

Intervention Type

Drug

Intervention Name(s)

MDGN-002

Other Intervention Name(s)

AVTX-002, AEVI-002

Intervention Description

MDGN-002 is a fully human IgG4 monoclonal antibody specific to human LIGHT.

Primary Outcome Measure Information:

Title

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Time Frame