Celiac DiseasePhase 1NCT02679014
A Study to Investigate the Pharmacokinetics, Pharmacodynamic Effects, Safety and Tolerability of Repeated Dosing of RO5459072 in Volunteers With Celiac Disease
A Phase 1 study testing RO5459072 in people with Celiac Disease, run by Hoffmann-La Roche at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Celiac Disease
- What is being tested?
- RO5459072
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Mar 2016to 28 Aug 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
Hammersmith Medicines Research Ltd.
London, NW10 7EW
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Parallel Study to Investigate the Pharmacokinetics, Pharmacodynamic Effects, Safety and Tolerability of Repeated Dosing of RO5459072 in Volunteers With Celiac Disease
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
- Being tested
- Placebo, RO5459072
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
RO5459072Drug
Also called RG7625
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).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will receive placebo capsules (2 capsules) twice daily for 28 days. Receives: Drug: Placebo |
| RO5459072 | Experimental | Participants will receive RO5459072 100 milligrams (mg) capsules (2*50 mg capsules) twice daily for 28 days. Receives: Drug: RO5459072 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 13 and Day 29
Secondary outcomes (10)
Percentage of Participants with Adverse Events (AEs)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Change from Baseline in Concentrations of Cathepsin S Mass Biomarker
Measured: Day 1 (Baseline), Day 7, Day 13, Day 21 and Day 29
Change from Baseline in Concentrations of Cystatin C Biomarker
Measured: Day 1 (Baseline), Day 7, Day 13, Day 21 and Day 29
Maximum Response (Emax ) in p10 upon Cathepsin S Inhibition Ex vivo
Measured: Day 1: pre-dose
Concentration of RO5459072 that Gives Half-maximal Response (EC50) in Ex Vivo p10 Stimulation Assay
Measured: Day 1: pre-dose
Change from Baseline in 4Beta-hydrocholesterol Concentration
Measured: Day 1 (Baseline), Day 7, Day 13, Day 21 and Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study start6 Mar 2016
- Primary completion28 Aug 2016
- Study completion28 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679014
- Sponsor's protocol ID
- BP29911
- Other IDs
- 2015-002864-18, 2015
- Status last verified
- Aug 2017
- First submitted
- 8 Feb 2016
- Last updated
- 25 Aug 2017
- Results posted
- No
Publications
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.
PubMed 39739628
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Parallel Study to Investigate the Pharmacokinetics, Pharmacodynamic Effects, Safety and Tolerability of Repeated Dosing of RO5459072 in Volunteers With Celiac Disease
- ClinicalTrials.gov ID
- NCT02679014
- Acronym / sponsor ID
- BP29911
- Conditions
- Celiac Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2016 (actual)
- Primary completion
- 28 Aug 2016 (actual)
- Study completion
- 28 Aug 2016 (actual)
- First posted
- 10 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo capsules (2 capsules) twice daily for 28 days. |
| RO5459072 | Experimental | Drug: RO5459072Participants will receive RO5459072 100 milligrams (mg) capsules (2*50 mg capsules) twice daily for 28 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboWith 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). | Drug | Placebo |
| RO5459072Also: RG7625With 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). | Drug | RO5459072 |
Primary outcome
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
Time frame: Day 13 and Day 29
10 secondary outcomes
Percentage of Participants with Adverse Events (AEs)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Change from Baseline in Concentrations of Cathepsin S Mass Biomarker
Time frame: Day 1 (Baseline), Day 7, Day 13, Day 21 and Day 29
Change from Baseline in Concentrations of Cystatin C Biomarker
Time frame: Day 1 (Baseline), Day 7, Day 13, Day 21 and Day 29
Maximum Response (Emax ) in p10 upon Cathepsin S Inhibition Ex vivo
Time frame: Day 1: pre-dose
Concentration of RO5459072 that Gives Half-maximal Response (EC50) in Ex Vivo p10 Stimulation Assay
Time frame: Day 1: pre-dose
Change from Baseline in 4Beta-hydrocholesterol Concentration
Time frame: Day 1 (Baseline), Day 7, Day 13, Day 21 and Day 29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2017.
- Derived from this study: PubMed 39739628Bentley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO5459072 in people with Celiac Disease, run by Hoffmann-La Roche at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Day 13 and Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02679014, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2017; AzTrials last refreshed its copy on 7 Nov 2026.