Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IDP-118 · 6 trials · 2 indications
Treatment success was defined as at least a 2-grade improvement from Baseline in IGA score and an IGA score equating to "Clear" or "Almost Clear". IGA was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Local skin reactions (itching, dryness, burning/stinging) graded at a level of 3 (severe) at any point in the study following the first application of study drug were assessed. Severe Itching (as reported by the participant within the last 24 hours) referred to the intense itching that may interrupt daily activities and/or sleep. Severe dryness (as assessed by the investigator) referred to as marked roughness of the skin. Severe burning/stinging (as reported by the participant within the last 24 hours) referred to as hot burning sensation that causes definite discomfort and may interrupt daily activities and/or sleep. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator's Global Assessment (IGA) score and an IGA score equating to "clear" or "almost clear". The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).
Treatment success defined as at least a 2-grade improvement from Baseline in the IGA score and an IGA score equating to "clear" or "almost clear" at Week 8. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).
Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator's Global Assessment (IGA) score and an IGA score equating to "clear" or "almost clear" at Weeks 2, 4, 6, and 12. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).
Tolerability will be evaluated through assessment of local signs and symptoms (itching, dryness, burning/stinging) on a scale of non, mild, moderate, and severe.
| Arm | Type | Description |
|---|---|---|
| IDP-118 Lotion | EXPERIMENTAL | Lotion |
| IDP-118 Vehicle Lotion | ACTIVE_COMPARATOR | Vehicle Lotion |
| Tazorac Cream | ACTIVE_COMPARATOR | Cream |
| IDP 118 Vehicle Lotion | ACTIVE_COMPARATOR | Lotion |
| IDP-118 Vehicle Cream | ACTIVE_COMPARATOR | Cream |
| IDP-118 Monad HP Lotion | ACTIVE_COMPARATOR | HP |
| IDP-118 Monad Taz Lotion | ACTIVE_COMPARATOR | Taz |
| HP Monad Lotion | EXPERIMENTAL | 8 Weeks |
| Ultravate Cream | ACTIVE_COMPARATOR | 2 Weeks |
| Name | Type | Description |
|---|---|---|
| IDP-118 Lotion | DRUG | Lotion |
| IDP-118 Vehicle Lotion | DRUG | Lotion |
| Tazorac Cream | DRUG | Cream |
| IDP-118 Vehicle Cream | DRUG | Cream |
| IDP-118 Monad HP Lotion | DRUG | Active Comparator |
| IDP-118 Monad Taz Lotion | DRUG | Active Comparator |
| HP Monad Lotion | DRUG | Lotion |
| Ultravate Cream | DRUG | Cream |
Key Inclusion Criteria: * Male or female, of any race, at least 18 years of age (inclusive). * Freely provides both verbal and written informed consent. * Has an area of plaque psoriasis appropriate for topical treatment that covers a BSA of at least 3%, but no more than 12%. The face, scalp, palms...
IDP-118 is an investigational small molecule being developed for the treatment of plaque psoriasis, a form of psoriasis. It is formulated as a lotion and is currently in clinical development, having completed Phase 3 trials.
IDP-118 is being developed by Bausch Health Companies Inc., a company traded on the stock exchange under the ticker symbol BHC. The drug is intended for use in dermatology, specifically for plaque psoriasis.
IDP-118 is in Phase 3 of clinical development. It has completed four clinical trials, including Phase 2 and Phase 3 studies, with a total enrollment of 1,185 participants. The drug is not yet approved and remains investigational.
IDP-118 has completed four clinical trials, all in the United States. These include NCT02045277 (Phase 2), NCT02462070 (Phase 3), NCT02462083 (long-term safety, Phase 3), and NCT02462122 (Phase 3). All trials studied the drug in patients with plaque psoriasis.
The specific molecular target of IDP-118 has not been disclosed. As a small molecule lotion for plaque psoriasis, it is applied topically, but its mechanism of action is not publicly detailed in the available information.
IDP-118 is not FDA approved. It is an investigational drug that has completed Phase 3 clinical trials, but approval status has not been granted. The drug remains in clinical development and is not yet available for commercial use.