NCT02679014

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2016

Completed
25 days until next milestone

Study Start

First participant enrolled

March 6, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2016

Completed
Last Updated

August 25, 2017

Status Verified

August 1, 2017

Enrollment Period

6 months

First QC Date

February 8, 2016

Last Update Submit

August 24, 2017

Conditions

Celiac Disease

Outcome Measures

Primary Outcomes (1)

  • Overall Numbers of Participants who are Responders to the Gluten Challenge, Defined as Participants with an Increase in Number of Gliadin Specific T-cells Above Assay-Specific Thresholds

    Day 13 and Day 29

Secondary Outcomes (10)

  • Percentage of Participants with Adverse Events (AEs)

    Up to Day 35

  • Number of Participants with an Increase in Antibody Titers (Anti-Tissue Transglutaminase [anti-tTG] Immunoglobulin A [IgA] and Immunoglobulin G [IgG] and Anti-Deamidated Gliadin Peptide (anti-DPG) IgA), as Determined Using Enzyme Immunoassay Methods

    Screening, Day 7, Day 13, Day 21, Day 29 and Day 35 (Follow up)

  • Lactulose to Mannitol Ratio (LMR), Determined by Urine Concentrations of Lactulose and Mannitol

    Day 7: 1 hour (hr) pre-dose to 1 hr post-dose, 1 hr to 3 hr post-dose, 3 hr to 5 hr post-dose and Day 21: 1 hr pre-dose to 1 hr post-dose, 1 to 3 hr post-dose, 3 hr to 5 hr post-dose

  • Change from Baseline in Number of Circulating White Blood Cells

    Day 1 (Baseline), Day 7, Day 13, Day 21, and Day 29

  • Change from Baseline in Concentrations of the 10 kilodalton (kDa) Cluster of Differentiation 74 (CD74) Intermediate (Fragment p10) in B Cells

    Day 1: pre-dose (=Baseline [BL]) and 4 hours (h) post-dose, Day 7: pre-dose and 4 h post-dose, Day 21: pre-dose and 4 h post-dose

  • +5 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

RO5459072

EXPERIMENTAL

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

Drug: RO5459072

Interventions

PlaceboDRUG

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).

Placebo
RO5459072DRUG

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).

Also known as: RG7625
RO5459072

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hammersmith Medicines Research Ltd.

London, NW10 7EW, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 39739628DERIVED

MeSH Terms

Conditions

Celiac Disease

Interventions

petesicatib

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2016

First Posted

February 10, 2016

Study Start

March 6, 2016

Primary Completion

August 28, 2016

Study Completion

August 28, 2016

Last Updated

August 25, 2017

Record last verified: 2017-08

Locations

GB(1)