Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as RG7625
RO5459072 · 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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Ianalumab |
| Bristol-Myers Squibb Company | BMY | 1 | PHASE3 | Deucravacitinib |
| Johnson & Johnson | JNJ | 1 | PHASE3 | Nipocalimab |
| argenx SE Sponsored ADR | ARGX | 2 | PHASE3 | Efgartigimod PH20 SC |
| Amgen Inc. | AMGN | 2 | PHASE3 | Dazodalibep |
| Vor Biopharma, Inc. | VOR | 1 | PHASE3 | Telitacicept |
| Immunovant Inc | IMVT | 1 | PHASE2 | IMVT-1402 |
| Artiva Biotherapeutics, Inc. | ARTV | 1 | PHASE2 | AB-101 |
| Cullinan Therapeutics, Inc. | CGEM | 1 | PHASE1 | CLN-978 |
| Lakefront Biotherapeutics Sponsored ADR | LKFT | 1 | PHASE1 | OM336 |
RO5459072 is an investigational small molecule being studied for the treatment of Sjogren's Syndrome and Celiac Disease. It is being developed by Roche Holding AG (RHHBY). The drug has been evaluated in clinical trials for these conditions, though it remains in clinical development and is not yet approved.
RO5459072 is a small molecule developed by Roche Holding AG (RHHBY). Its specific molecular target is not disclosed in available information. The drug is being investigated for its effects in Sjogren's Syndrome and Celiac Disease, but its mechanism of action has not been publicly detailed.
RO5459072 is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Sjogren's Syndrome and Celiac Disease.
RO5459072 has completed a Phase 1 trial in Celiac Disease and a Phase 2 trial in Sjogren's Syndrome. Both studies are completed, and the drug is still in clinical development. It is not FDA approved and remains investigational.
RO5459072 has been studied in two completed trials. NCT02679014 was a Phase 1 study in 19 volunteers with Celiac Disease in the United Kingdom. NCT02701985 was a Phase 2 study in 75 participants with Sjogren's Syndrome across the US, France, Germany, Poland, Portugal, and the UK.
RO5459072 is the only name provided for this investigational drug. No alternative names or aliases have been associated with it in available information. It is a distinct small molecule being developed by Roche Holding AG.