Evaluation of the Efficacy and Safety of ALV003 in Symptomatic in Celiac Disease Patients

Conditions

Celiac Disease

Keywords

Celiac disease, Gluten-free diet, Coeliac disease, Celiac sprue

Brief summary

To determine the effects of 12 weeks administration of different dose levels of ALV003 on the mucosal lining of the small intestine and symptoms in celiac disease patients.

Jack A. Syage, Philip T. Lavin

International Journal of Celiac Disease2020-08-03

10.12691/ijcd-8-3-3

Latiglutenase Treatment for Celiac Disease: Symptom and Quality of Life Improvement for Seropositive Patients on a Gluten-Free Diet.

Syage JA, Green PHR, Khosla C, Adelman DC, Sealey-Voyksner JA, Murray JA.

2019-10-0831 citations

10.1002/ygh2.371

Latiglutenase Improves Symptoms in Seropositive Celiac Disease Patients While on a Gluten-Free Diet.

Syage JA, Murray JA, Green PHR, Khosla C.

2017-07-2854 citations

10.1007/s10620-017-4687-7

No Difference Between Latiglutenase and Placebo in Reducing Villous Atrophy or Improving Symptoms in Patients With Symptomatic Celiac Disease.

Murray JA, Kelly CP, Green PHR, Marcantonio A, Wu TT, Mäki M, Adelman DC, CeliAction Study Group of Investigators.

2016-11-1593 citations

10.1053/j.gastro.2016.11.004

Interventions

DRUGALV003

ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase)

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

No

Inclusion criteria

* Ages 18 to 80 years * Physician diagnosed celiac disease * Adherence to a gluten-free diet * Experiencing symptoms of celiac disease over a 1-month period * Willing to take study medication for 12 weeks * Willing to comply with all study procedures * Sign informed consent

Exclusion criteria

* Active inflammatory bowel disease * Active dermatitis herpetiformis * Use of certain specific medications prior to entry * History of alcohol or illicit drug abuse in previous 6 months * Pregnant or lactating * Received any experimental drug within 30 days of enrollment * Uncontrolled chronic disease or condition

Design outcomes

Primary

Measure	Time frame	Description
Efficacy: Intestinal mucosal morphometry	12 weeks	Change in villus height to crypt depth (Vh:Cd) ratio between baseline and week 12

Secondary

Measure	Time frame	Description
Efficacy: Intestinal intraepithelial lymphocyte density	12 weeks	Change in intestinal intraepithelial lymphocytes between baseline and week 12 (CD3+ cells/100 epithelial cells)
Safety: safety and tolerability of ALV003	12 weeks	Incidence of adverse events between baseline and week 12

Other

Measure	Time frame
Celiac disease-specific serology	12 weeks
Quality of life	12 weeks

Countries

Canada, Finland, Ireland, Norway, United Kingdom, United States

Outcome results

None listed