Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as RO5459072
RG7625 · 4 trials · 3 indications
Percentage of participants with a clinically relevant decrease in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) Score is defined as participants with absolute decrease of ≥ 3-points in ESSDAI score. ESSDAI is physician-assessed disease activity index developed by EULAR consortium consisting of 44 items in 12 organ-specific 'domains' (constitutional,lymphadenopathy, articular,muscular,cutaneous,glandular,pulmonary,renal,peripheral nervous system,central nervous system,hematological,biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity). A score ≥ 5 is considered moderate or severe disease activity and a clinically relevant change in ESSDAI score is defined as absolute decrease of ≥ 3-points.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Matching-placebo capsules will be administered orally, 2 times a day, for up to 12 weeks. |
| RO5459072 | EXPERIMENTAL | RO5459072 at a dose of 100 milligrams (as capsules) will be administered orally, 2 times a day, for up to 12 weeks. |
| RG7625 | EXPERIMENTAL | Participants will undergo a series of Screening visits prior to treatment and 7- to 14-day follow-up. Healthy volunteers will be enrolled in up to 4 cohorts and will receive RG7625 as oral capsules once or twice daily for 8 days. The first cohort is planned to receive 100 milligrams (mg) on Day 1, followed by 100 mg twice daily on Days 3 to 9. Subsequent dose and frequency decisions will be based upon observations in previous cohort(s). Each cohort will receive intradermal administration of 4 antigens (tetanus toxoid, tuberculin PPD, Candida albicans, and Trichophyton species) and a negative control at Screening and on Day 7 of treatment to assess for DTH. |
| Cohort A | EXPERIMENTAL | - |
| Cohort B | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Matching-placebo capsules will be administered orally, 2 times a day with food. |
| RO5459072 | DRUG | RO5459072 at a dose of 100 milligrams (as capsules) will be administered orally, 2 times a day with food. |
| RG7625 | DRUG | Participants will receive RG7625 as oral capsules once or twice daily for 8 days. The first dose will be administered on Day 1 and the regimen will be continued during Days 3 to 9, with only a single dose given on Day 9. |
Inclusion Criteria: * A diagnosis of primary Sjogren's syndrome according to the revised American-European Consensus Group (AECG) criteria * ESSDAI score greater than or equal to (\>/=) 5 * ESSPRI score \>/=5 * Elevated serum titers of anti-Sjogren's-syndrome-related antigen A (anti-SSA) and/or ant...
RG7625 is an investigational small molecule developed by Roche Holding AG. It has been studied in Phase 1 clinical trials in healthy volunteers. No therapeutic indication for RG7625 has been disclosed, and the compound has not been approved for any use.
RG7625 targets cathepsin S, an enzyme. Cathepsin S is a cysteine protease, and RG7625 is a small molecule designed to act on this enzyme target. This mechanism information comes from the drug's disclosed molecular target, not from clinical outcome data.
RG7625 is developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is the sponsor of the clinical studies conducted with RG7625 to date.
RG7625 is in Phase 1. Both of its recorded clinical trials are Phase 1 studies that have been completed, and no active trials are ongoing. RG7625 is investigational and has not been approved by the FDA for any indication.
RG7625 has been evaluated in two completed Phase 1 trials: NCT02521610, a multiple ascending-dose study in healthy volunteers with 33 participants, and NCT02295332, a study in healthy volunteers with 17 participants. Both were conducted in the Netherlands and together enrolled 50 participants.
Yes. The RG7625 Phase 1 program used randomized, double-blind, controlled designs. The two completed studies enrolled a total of 50 healthy volunteers in the Netherlands, with participants aged 18 years and older and no biomarker-based selection.