Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01916967 | An Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Chronic Urticaria (MK-4117-201) | PHASE3 | COMPLETED | 239 | — | — | Aug 27, 2013 | Mar 13, 2014 | Jun 18, 2024 | - | — |
| NCT00795158 | How Desloratadine (Clarinex, Aerius) Affects Quality of Life in Patients With Chronic Idiopathic Urticaria (Have Had Hives for 6 Weeks or Longer)(Study P02988) | PHASE3 | COMPLETED | 282 | — | — | Nov 1, 2002 | Jan 1, 2004 | Feb 17, 2022 | - | — |
The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The score used for pruritus/itch was the higher of the day or night scores (0=Asymptomatic to 4=Severe). The Investigator also assessed the severity of participant rash using the overall rash score (0=No rash to 3=Looks very bad). The sum of the pruritus/itch score (0-4) and rash score (0-3) could range from 0 to 7, with a higher sum score indicating greater severity. The change from Baseline in the sum of the pruritus/itch and overall rash scores at the Week 2 clinic visit was calculated.
An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE.
An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE.
| Arm | Type | Description |
|---|---|---|
| Desloratadine 5 mg | EXPERIMENTAL | Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks |
| Desloratadine 10 mg | EXPERIMENTAL | Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks |
| Placebo | PLACEBO_COMPARATOR | Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks |
| Arm 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Desloratadine | DRUG | Desloratadine 5 mg tablets, given orally, once daily in the evening for 2 weeks |
| Placebo | DRUG | Placebo tablets, given orally, once daily in the evening for 2 weeks |
Inclusion Criteria: * Chronic urticaria \[rash (erythema, wheal) for more than 1 month without any known cause\] * Out-patient Exclusion Criteria: * Stimulation-induced urticaria \[physical urticaria (e.g. cold, solar, and heat urticaria), cholinergic urticaria, contact urticaria)\] * Hypersensit...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 10 | PHASE3 | LOU064, Remibrutinib, Omalizumab, Dupilumab |
| Celldex Therapeutics, Inc. | CLDX | 4 | PHASE3 | barzolvolimab, Barzolvolimab |
| Pfizer Inc. | PFE | 1 | PHASE2 | Ritlecitinib |
| Evommune, Inc. | EVMN | 1 | PHASE2 | EVO756 |
| ARS Pharmaceuticals, Inc. | SPRY | 1 | PHASE2 | epinephrine |
| Jasper Therapeutics, Inc. | JSPR | 2 | PHASE2 | Briquilimab |
| Blueprint Medicines Corporation | BPMC | 1 | PHASE2 | BLU-808 |
| Azitra Inc. | AZTR | 1 | PHASE1 | ATR04-484, Vehicle |
| BeOne Medicines Ltd. Sponsored ADR | ONC | 1 | PHASE1 | BGB-16673 |
| Sanofi SA Sponsored ADR | SNY | 1 | — | Dupilumab |
| Enanta Pharmaceuticals, Inc. | ENTA | 1 | PHASE1 | EDP-978 |