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

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Roche

Status and phase

Completed
Phase 1

Conditions

Celiac Disease

Treatments

Drug: RO5459072
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02679014
2015-002864-18 (EudraCT Number)
BP29911

Details and patient eligibility

About

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).

Enrollment

19 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

19 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Participants will receive placebo capsules (2 capsules) twice daily for 28 days.
Treatment:
Drug: Placebo
RO5459072
Experimental group
Description:
Participants will receive RO5459072 100 milligrams (mg) capsules (2*50 mg capsules) twice daily for 28 days.
Treatment:
Drug: RO5459072

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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