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

Browse trials for

• Colitis 1,074
• Crohn Disease 1,875
• Colitis, Ulcerative 1,485
• Ulcer 2,023

Study arms

• Experimental
  MDGN-002

  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

• DrugMDGN-002

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

  Also known as: AVTX-002, AEVI-002

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

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

Secondary outcomes

1. 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.

2. 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

3. Change From Baseline in Total Number of Stools Daily

   Subjects reported their daily stool frequency including loose and/or watery stools via a diary. The stool frequency including the number of loose and/or watery stools per day, equivalent to a score of a 6 or 7 on the Bristol Stool Scale, was recorded. Loose stools were described as fluffy pieces with ragged edges, a mushy stool. Watery stools were described as watery, no solid pieces.

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

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

   Subjects reported their daily assessment of stool frequency including loose and/or watery stools via a diary. The stool frequency including the number of loose and/or watery stools per day, equivalent to a score of a 6 or 7 on the Bristol Stool Scale, was recorded. Loose stools were described as fluffy pieces with ragged edges, a mushy stool. Watery stools were described as watery, no solid pieces.

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

5. Change From Baseline in Abdominal Pain

   Subjects reported their daily assessment of abdominal pain via a diary. Abdominal pain was assessed on a scale of 0 to 3 with higher values indicating greater pain severity.

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

6. Change From Baseline in General Well-Being

   Subjects reported their daily assessment of well-being via a diary. General well being was assessed on a scale of 0 to 4, with higher values indicating a poorer condition of health.

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

Baseline characteristics

Study documents

• Study protocol · Jul 23, 2021
• Statistical analysis plan · Oct 5, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No