Clinical trial NCT03169894: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Crohn Disease
Ulcerative Colitis
Lead sponsor: Avalo Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-05-30
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD)
timeFrame: Baseline to Visit 10 (Day 56) or early termination
Secondary outcomes:
measure: Change From Baseline in Crohn's Disease Activity Index (CDAI)
timeFrame: Baseline to Visit 10 (Day 56) or early termination.
measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBD-Q).
timeFrame: Baseline to Visit 10 (Day 56) or Early Termination
measure: Change From Baseline in Total Number of Stools Daily
timeFrame: Baseline to Visit 10 (Day 56) or Early Termination
measure: Change From Baseline in Total Number of Loose/Watery Stools Daily
timeFrame: Baseline to Visit 10 (Day 56) or Early Termination
measure: Change From Baseline in Abdominal Pain
timeFrame: Baseline to Visit 10 (Day 56) or Early Termination
measure: Change From Baseline in General Well-Being
timeFrame: Baseline to Visit 10 (Day 56) or Early Termination
Other outcomes:
Locations:
city: Hialeah
country: United States
facility: Sweet Hope Research Specialty, Inc.
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute, Inc.
state: Florida
city: Atlanta
country: United States
facility: Egleston Hospital
state: Georgia
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Center for Pediatric Inflammatory Bowel Disease, Children's Hospital of Philadelphia
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: San Antonio
country: United States
facility: Clinical Associates in Research Therapeutics of America, LLC
state: Texas
city: Salt Lake City
country: United States
facility: Care Access Research
state: Utah
Study officials:
References: