Randomized Stepped Wedge Study of Emapalumab in APECED Enteritis
Recruiting
Phase 2
Interventional Study
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy Enteritis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 2 – 75
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 10 (estimated)
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID) · NIH
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 AP…
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
* INCLUSION CRITERIA:
1. Participant must be able to understand and provide informed consent.
2. Aged \>= 2 to \<= 75 years.
3. Currently co-enrolled on NIH protocol 11-I-0187, "The Natural History and Pathogenesis of Human Fungal Infections."
4. Patients with APECED (genetic or clinical di…
Contacts