Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO5459072 · 2 trials · 2 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. |
| 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. |
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 | VAY736 |
| Amgen Inc. | AMGN | 3 | PHASE3 | Dazodalibep |
| Bristol-Myers Squibb Company | BMY | 1 | PHASE3 | Deucravacitinib |
| Johnson & Johnson | JNJ | 1 | PHASE3 | Nipocalimab |
| argenx SE Sponsored ADR | ARGX | 1 | PHASE3 | Efgartigimod PH20 |
| Vor Biopharma, Inc. | VOR | 1 | PHASE3 | Telitacicept |
| Immunovant Inc | IMVT | 1 | PHASE2 | IMVT-1402 |
| Artiva Biotherapeutics, Inc. | ARTV | 1 | PHASE2 | Allogeneic NK Cells |
| Cullinan Therapeutics, Inc. | CGEM | 1 | PHASE1 | CLN-978 |
| Precision BioSciences, Inc. | DTIL | 1 | PHASE1 | CD19 targeted CAR-T cells |
RO5459072 is an investigational small molecule being studied for the treatment of Celiac Disease and Sjogren's Syndrome. It is being developed by Roche Holding AG (RHHBY). The drug has been evaluated in clinical trials for both conditions, with studies completed in the United Kingdom, United States, France, Germany, Poland, and Portugal.
RO5459072 is a small molecule developed by Roche Holding AG (RHHBY). Its specific molecular target has not been disclosed in available clinical trial information. The drug is being investigated for its effects in Celiac Disease and Sjogren's Syndrome, with studies focusing on pharmacokinetics, pharmacodynamics, efficacy, safety, and tolerability.
RO5459072 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company has sponsored clinical trials of the drug in Celiac Disease and Sjogren's Syndrome. These trials have been conducted in multiple countries, including the United States, United Kingdom, France, Germany, Poland, and Portugal.
RO5459072 has been studied in both Phase 1 and Phase 2 clinical trials. A Phase 1 trial in Celiac Disease has been completed, and a Phase 2 trial in Sjogren's Syndrome has also been completed. The drug is investigational and has not been approved by regulatory authorities.
RO5459072 has been evaluated in two completed clinical trials. NCT02679014 was a Phase 1 study in participants with Celiac Disease, enrolling 19 people in the United Kingdom. NCT02701985 was a Phase 2 study in participants with Sjogren's Syndrome, enrolling 75 people across the United States, France, Germany, Poland, Portugal, and the United Kingdom.
RO5459072 is the only name provided for this investigational drug. It is being developed by Roche Holding AG (RHHBY) for Celiac Disease and Sjogren's Syndrome. No alternative names have been reported in the clinical trial information available.