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NCT07202598 · ClinicalTrials.gov registry record · Phase 2
Randomized Stepped Wedge Study of Emapalumab in APECED Enteritis
A Phase 2 study of Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy Enteritis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT07202598: Recruiting Phase 2 study of Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy Enteritis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT07202598 is a Phase 2 study of Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy Enteritis that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07202598, a Phase 2 study of Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy Enteritis, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Autoimmune polyendocrinopathy-candidiasis-ectodermal dystrophy (APECED), also known as Autoimmune polyendocrine syndrome type-1 (APS-1), is a disease that causes the immune system to attack parts of a person s body. In some people, APECED attacks the small intestine; this causes an illness called enteritis. Objective: To test a drug (emapalumab) in people with enteritis caused by APECED. Eligibility: People aged 2 to 75 years with APECED and enteritis. They must also be enrolled in protocol 11-I-0187. Design: Participants will have 10-13 study visits in an 18-month period. Participants will be screened. They will have a physical exam with blood tests. These tests will be repeated at every study visit. They will have a test of their heart function. This will be at screening and prior to drug administration. Other tests are optional: Participants may have imaging exams and a test of lung function. They may have an endoscopy, which is an exam of their digestive tract. Participants may provide samples of urine, stool, nail clippings, saliva, vaginal fluid, or skin. Photos may be taken of their skin or scalp. These tests may be repeated at some visits. Emapalumab is given through a tube attached to a needle inserted into a vein. All participants will receive 7 doses: 2 on their first study visit; then 1 each at 30-day intervals. Some participants will have an observation period before they begin taking the drug; in those situations, they will either be seen in person or via video visit every 2 months before starting emapalumab to see how their symptoms change over time. Participants will have a follow-up visit 1 month after their last dose. Then they will have 2 telehealth visits at 30-day intervals. They will have a final clinic visit 1 year after their first dose. ...
Primary Outcome
To evaluate the efficacy of emapalumab on gastrointestinal (GI) symptoms as measured by the APECED enteritis score (APECED ES) in participants with APECED enteritis.
Conditions Studied
Interventions
- DRUG Emapalumab
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2025-11-12 |
| Est. Completion | 2031-09-01 |
| Phase | Phase 2 |
What NCT07202598 shows while recruiting
NCT07202598 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy Enteritis appearing as the primary indexed condition, and to 1 intervention - of which Emapalumab is the first listed.
NCT07202598 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT07202598 about?
NCT07202598 is a clinical study titled "Randomized Stepped Wedge Study of Emapalumab in APECED Enteritis". Background: Autoimmune polyendocrinopathy-candidiasis-ectodermal dystrophy (APECED), also known as Autoimmune polyendocrine syndrome type-1 (APS-1), is a disease that causes the immune system to attack parts of a person s body. In some people, APECED attacks the small intestine; this causes an illn...
What is the current status of trial NCT07202598?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2025-11-12. Estimated completion is 2031-09-01.
What conditions does trial NCT07202598 study?
This clinical trial studies the following conditions: Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy Enteritis.
What interventions are being tested in trial NCT07202598?
The interventions under investigation include: Emapalumab (DRUG).
Who is sponsoring clinical trial NCT07202598?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07202598 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07202598's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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