Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis
Public ClinicalTrials.gov record NCT03169894. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03169894
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 8 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 14, 2017 (Actual)
- Primary completion
- Sep 14, 2021 (Actual)
- Completion
- Oct 12, 2021 (Actual)
- Last update posted
- Feb 26, 2024
2017 – 2021
United States locations
- U.S. sites
- 13
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sweet Hope Research Specialty, Inc. | Hialeah | Florida | 33016 | — |
| Advanced Research Institute, Inc. | New Port Richey | Florida | 34653 | — |
| Egleston Hospital | Atlanta | Georgia | 30322 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Hassman Research Institute | Berlin | New Jersey | 08900 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | — |
| The Center for Pediatric Inflammatory Bowel Disease, Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
| Clinical Associates in Research Therapeutics of America, LLC | San Antonio | Texas | 78212 | — |
| Care Access Research | Salt Lake City | Utah | 84124 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03169894, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 26, 2024 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03169894 live on ClinicalTrials.gov.