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

NCT ID: NCT02679014

Last Updated: 2017-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-06
• Study Completion Date: 2016-08-28

Brief Summary

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).

Conditions

Celiac Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Participants will receive placebo capsules (2 capsules) twice daily for 28 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

With the exception of the mornings of Days 7 and 21, placebo capsules will be taken orally with a glass of still water in the morning and evening under fed conditions. On the mornings of Days 7 and 21, placebo will be administered under fasted conditions (overnight fast of at least 8 hours before dosing).

RO5459072

Participants will receive RO5459072 100 milligrams (mg) capsules (2\*50 mg capsules) twice daily for 28 days.

Group Type: EXPERIMENTAL

RO5459072

Intervention Type: DRUG

With the exception of the mornings of Days 7 and 21, RO5459072 capsules will be taken orally with a glass of still water in the morning and evening under fed conditions. On the mornings of Days 7 and 21, RO5459072 will be administered under fasted conditions (overnight fast of at least 8 hours before dosing).

Interventions

Placebo

With the exception of the mornings of Days 7 and 21, placebo capsules will be taken orally with a glass of still water in the morning and evening under fed conditions. On the mornings of Days 7 and 21, placebo will be administered under fasted conditions (overnight fast of at least 8 hours before dosing).

Intervention Type: DRUG

RO5459072

With the exception of the mornings of Days 7 and 21, RO5459072 capsules will be taken orally with a glass of still water in the morning and evening under fed conditions. On the mornings of Days 7 and 21, RO5459072 will be administered under fasted conditions (overnight fast of at least 8 hours before dosing).

Intervention Type: DRUG

Other Intervention Names

RG7625

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Hammersmith Medicines Research Ltd.

London, , United Kingdom

Countries

United Kingdom

References

Bentley D, Mannino M, Manchester M, Teixeira PC, Reis B, Boyce M, Nagel S. A randomized, double-blind, placebo-controlled, multiple dose, parallel study to investigate the effects of a cathepsin S inhibitor in celiac disease. Clin Transl Sci. 2025 Jan;18(1):e13901. doi: 10.1111/cts.13901.

Reference Type: DERIVED

PMID: 39739628 (View on PubMed)

Other Identifiers

2015-002864-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BP29911

Identifier Type: -

Identifier Source: org_study_id