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

NCT03169894 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: MDGN-002-CD-101
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 13

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.

Conditions

Crohn Disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD)

  The SES-CD is assessed through endoscopic review of 5 predefined gastrointestinal (GI) segments (ileum; right colon; transverse colon; left colon; rectum). For each segment, 4 endoscopic variables are assessed (presence of ulcers, ulcerated surface, affected surface, and presence of narrowing). Each variable is scored from 0 to 3 with higher scores indicating more severe symptoms. For each variable, the total score is calculated as the sum across all segments of the GI tract. 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

  Baseline to Visit 10 (Day 56) or early termination

Secondary Outcomes (6)

• Change From Baseline in Crohn's Disease Activity Index (CDAI)

  Baseline to Visit 10 (Day 56) or early termination.

• Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBD-Q).

  Baseline to Visit 10 (Day 56) or Early Termination

• Change From Baseline in Total Number of Stools Daily

  Baseline to Visit 10 (Day 56) or Early Termination

• Change From Baseline in Total Number of Loose/Watery Stools Daily

  Baseline to Visit 10 (Day 56) or Early Termination

• Change From Baseline in Abdominal Pain

  Baseline to Visit 10 (Day 56) or Early Termination

Study Arms (1)

MDGN-002

EXPERIMENTAL

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.

Drug: MDGN-002

Interventions

MDGN-002 DRUG

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

Also known as: AVTX-002, AEVI-002

MDGN-002

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is male or female, ≥ 18 to ≤ 75 years of age.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Avalo Therapeutics, Inc.: lead

Study Sites (13)

Sweet Hope Research Specialty, Inc.

Hialeah, Florida, 33016, United States

Location

Advanced Research Institute, Inc.

New Port Richey, Florida, 34653, United States

Location

Egleston Hospital

Atlanta, Georgia, 30322, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08900, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

The Center for Pediatric Inflammatory Bowel Disease, Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Clinical Associates in Research Therapeutics of America, LLC

San Antonio, Texas, 78212, United States

Location

Care Access Research

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Limitations and Caveats

This was an open label study, exploratory in nature, without a placebo control group, and as such, limits the interpretation of the study data.

Results Point of Contact

• Title: Garry Neil, MD
• Organization: Avalo Therapeutics, Inc.

gneil@avalotx.com

908-720-2691

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 30, 2017
• Study Start: July 14, 2017
• Primary Completion: September 14, 2021
• Study Completion: October 12, 2021
• Last Updated: February 26, 2024
• Results First Posted: February 26, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)