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

Phase 1TerminatedNCT03169894

Avalo Therapeutics, Inc.8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Crohn Disease Ulcerative Colitis

Interventions

MDGN-002DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject is male or female, ≥ 18 to ≤ 75 years of age. 2. 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. 3. 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. 4. Subject has failed treatment with an approved therapeutic dose of an anti-TNFα monoclonal antibody treatment. Exclusion Criteria: 1. Subject has a diagnosis of ulcerative colitis (UC) or indeterminate colitis or subject has a diagnosis of Crohn's disease or indeterminate colitis . 2. Subject with signs or symptoms of bowel obstruction. 3. Subject has short bowel syndrome. 4. Subject has a current functional colostomy or ileostomy. 5. Subject has had a surgical bowel resection within the past 6 months prior to screening or is planning any resection during the study period. 6. Subject is pregnant or a nursing mother. 7. Subject is sexually active and not using effective contraception as defined in the protocol.

Locations (13)

Sweet Hope Research Specialty, Inc.

Hialeah, Florida, United States

Advanced Research Institute, Inc.

New Port Richey, Florida, United States

Egleston Hospital

Outcomes

Primary Outcomes

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

Time frame: Baseline to Visit 10 (Day 56) or early termination

Secondary Outcomes

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

The Crohn's Disease Activity Index (CDAI) consists of the following 8 items: abdominal pain, number of liquid stools, general well-being, extraintestinal complication, use of antidiarrheal drugs, abdominal mass, hematocrit, and body weight. Information on abdominal pain, general well-being, and frequency of loose and watery stools was taken from a daily diary completed by the subject. Total CDAI scores can range from 0 to approximately 600 with higher scores indicating more active disease. Disease severity as measured by CDAI is categorized as: Remission (\<150), Mildly active disease (150 - 219); Moderately active disease (220 - 450); Severe disease (\> 450).

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

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

The IBD-Q is a 32-item questionnaire validated to measure quality of life in Crohn's disease subjects. The IBD-Q assesses the dimensions of bowel function, emotional status, systemic symptoms, and social function. Each of the 32 items is scored on a 1 to 7 scale, where higher scores represent a more positive response, and better outcome. The IBD-Q total score is calculated as the sum of all 32 items in the questionnaire, ranging from 32 to 224.

Time frame: Baseline to Visit 10 (Day 56) or Early Termination

Data from ClinicalTrials.gov

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