NCT01893775

Antibody Treatment for Advanced Celiac Disease

Completed Phase 1 Last updated 18 January 2020

What this trial tests

Phase 1 trial testing Hu-Mik- Beta-1 in Celiac Disease in 5 participants. Completed in 20 December 2019.

Timeline

12 June 2013

Primary endpoint
20 December 2019

20 December 2019

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	12 June 2013
Primary completion	20 December 2019
Estimated completion	20 December 2019
Sites	1 location across United States

Drugs / interventions tested

• Hu-Mik- Beta-1

Conditions studied

• Celiac Disease — all drugs for Celiac Disease →
• Celiac Sprue — all drugs for Celiac Sprue →
• Gluten Enteropathy — all drugs for Gluten Enteropathy →
• Gluten-Sensitive Enteropathy — all drugs for Gluten-Sensitive Enteropathy →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 18 to 100, any sex, with Celiac Disease or Celiac Sprue. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

\- Celiac disease is a condition where the immune system attacks the cells of the small intestine. The intestine becomes inflamed and cannot digest food properly. The disease most often causes a reaction to foods that contain gluten. Most people can treat celiac disease with a gluten-free diet. However, some people have digestion problems even on a gluten-free diet. Researchers want to try a new antibody therapy for celiac disease. The treatment may block the immune reaction that causes the disease. They will test this antibody in people who have celiac disease that has not responded to a gluten-free diet.

Objectives:

\- To see if antibody therapy is a safe and effective treatment for celiac disease that has not responded to standard treatments.

Eligibility:

\- Individuals at least 18 years of age who have been on a gluten-free diet for 6 to 12 months but still have symptoms of celiac disease.

Design:

* Participants will be screened with a physical exam and medical history. Blood samples will be collected. These samples will help determine if the specific antibody treatment is likely to work.
* Before the start of the study, participants will have a biopsy of the small intestine.
* Participants will receive three doses of the study antibody as injections. These doses will be given 3 weeks apart.
* Treatment will be monitored with blood tests and heart function tests. Participants will also have a second small intestine biopsy within a week after the last dose of the antibody.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interleukin-15 (dys)regulation of lymphoid homeostasis: Implications for therapy of autoimmunity and cancer.
   Waldmann TA, Miljkovic MD, Conlon KC. · · 2020 · cited 96× · PMID 31821442 · DOI 10.1084/jem.20191062
2. The present and the future in the diagnosis and management of celiac disease.
   Castillo NE, Theethira TG, Leffler DA. · · 2015 · cited 51× · PMID 25326000 · DOI 10.1093/gastro/gou065
3. Novel Nondietary Therapies for Celiac Disease.
   Alhassan E, Yadav A, Kelly CP, Mukherjee R. · · 2019 · cited 37× · PMID 31146067 · DOI 10.1016/j.jcmgh.2019.04.017
4. Celiac disease: mechanisms and emerging therapeutics.
   Besser HA, Khosla C. · · 2023 · cited 31× · PMID 37839914 · DOI 10.1016/j.tips.2023.09.006
5. Gliadin Sequestration as a Novel Therapy for Celiac Disease: A Prospective Application for Polyphenols.
   Van Buiten CB, Elias RJ. · · 2021 · cited 14× · PMID 33435615 · DOI 10.3390/ijms22020595
6. Celiac Disease and Non-celiac Wheat Sensitivity: State of Art of Non-dietary Therapies.
   Serena G, D'Avino P, Fasano A. · · 2020 · cited 13× · PMID 33015123 · DOI 10.3389/fnut.2020.00152
7. The production of a recombinant tandem single chain fragment variable capable of binding prolamins triggering celiac disease.
   Eggenreich B, Scholz E, Wurm DJ, Forster F, et al · · 2018 · cited 4× · PMID 29843684 · DOI 10.1186/s12896-018-0443-0
8. From an understanding of etiopathogenesis to novel therapies-what is new in the treatment of celiac disease?
   Skoracka K, Hryhorowicz S, Tovoli F, Raiteri A, et al · · 2024 · cited 2× · PMID 38698821 · DOI 10.3389/fphar.2024.1378172