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A Study to Investigate the Pharmacokinetics, Pharmacodynamic Effects, Safety and Tolerability of Repeated Dosing of RO5459072 in Volunteers With Celiac Disease

NCT02679014

CompletedPhase 1

Sponsor: Hoffmann-La Roche

Conditions: Celiac Disease

Interventions: Placebo, RO5459072

Countries: United Kingdom

A randomized, double-blind, placebo-controlled, two treatment, parallel group study to investigate the effects of RO5459072, a cathepsin S inhibitor, on the immune response to a gluten challenge in volunteers with celiac disease. Volunteers with previously diagnosed celiac disease will be randomized to receive either 100 milligrams (mg) RO5459072 or placebo twice daily with food for 28 days (Days 1 to 28).

Eligibility overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Volunteers with a biopsy confirmed diagnosis of celiac disease
* Human leukocyte antigen (HLA) serotype DQ 2.5 and HLA-DQ 8 haplotypes
* Maintaining a gluten-free diet for at least one year. Compliance will be assessed by serology, compatible responses to a self-reported assessment of gluten-free diet adherence and the absence of typical celiac disease symptoms
* Able to participate and to comply with the study restrictions including the requirements of the gluten challenge

Exclusion Criteria:

* A diagnosis of non-celiac gluten sensitivity
* A personal history of food intolerance other than to gluten, or diagnosis of galactosemia, lactose, galactose or fructose intolerance
* A personal history of severe acute symptomatic reaction to sporadic gluten ingestion
* A diagnosis of refractory celiac disease or presence of severe complications of celiac disease
* Diagnosed or suspected immunoglobulin A (IgA) deficiency
* Acute inflammatory bowel disease (ulcerative colitis, Crohn's disease), gastrointestinal obstruction or sub-occlusive syndromes, digestive perforation or risk of digestive perforation, painful abdominal syndromes of undetermined cause
* A history of stomach or intestinal surgery or resection. Appendectomy and hernia repair are acceptable
* Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple allergies (non-active hay fever is acceptable)
* Immunocompromised or with reduced immune function considered to be clinically significant by the Investigator
* Immunization within 30 days before the screening visit or planning vaccination during the study
* Women who are pregnant or lactating, or who are of child-bearing potential and do not agree to comply with requirements for contraceptive use. Men who do not agree to comply with requirements for contraceptive use and restrictions on sperm donation
* Participation in an investigational drug or device study within the three months preceding the screening visit

Locations (1)

London, United Kingdom