Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002864-18 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants will receive placebo capsules (2 capsules) twice daily for 28 days. |
|
| RO5459072 | Experimental | Participants will receive RO5459072 100 milligrams (mg) capsules (2*50 mg capsules) twice daily for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Medicines Research Ltd. | London | NW10 7EW | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39739628 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| RO5459072 | 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). |
|
|
| 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 |
| Change from Baseline in Concentrations of Cathepsin S Mass Biomarker | Day 1 (Baseline), Day 7, Day 13, Day 21 and Day 29 |
| Change from Baseline in Concentrations of Cystatin C Biomarker | Day 1 (Baseline), Day 7, Day 13, Day 21 and Day 29 |
| Maximum Response (Emax ) in p10 upon Cathepsin S Inhibition Ex vivo | Day 1: pre-dose |
| Concentration of RO5459072 that Gives Half-maximal Response (EC50) in Ex Vivo p10 Stimulation Assay | Day 1: pre-dose |
| Change from Baseline in 4Beta-hydrocholesterol Concentration | Day 1 (Baseline), Day 7, Day 13, Day 21 and Day 29 |
| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000709727 | petesicatib |
Not provided
Not provided
Not provided