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.
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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
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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
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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

Michail S Lionakis, M.D.

(301) 443-5089

lionakism@mail.nih.gov

CONTACT