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Also known as IDP-118 Lotion
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 topical lotion being developed for the treatment of plaque psoriasis, including moderate to severe forms of the condition. It is a small molecule therapy applied directly to the skin and is being studied in adult patients aged 18 years and older.
IDP-118 is being developed by Bausch Health Companies Inc., which trades on the New York Stock Exchange under the ticker BHC. The company has sponsored the clinical trial program evaluating the lotion in patients with plaque psoriasis across Phase 1, Phase 2, and Phase 3 studies.
IDP-118 is in Phase 3 clinical development. Four trials have been completed, including two Phase 3 studies, and no trials are currently listed as active. The program has enrolled a total of 1,185 participants across its completed studies.
IDP-118 has been studied in four completed trials: NCT03058744 (Phase 1), NCT02785159 (Phase 2), NCT02462122 (Phase 3), and NCT02462083 (Phase 3, long-term safety). All were conducted in the United States in adults with psoriasis, and the Phase 3 studies enrolled 215 and 555 participants respectively.
Yes, IDP-118 Lotion is an alternative name for IDP-118. Both refer to the same investigational topical small molecule therapy developed by Bausch Health for plaque psoriasis, and the trial titles use the two names interchangeably across the Phase 1, Phase 2, and Phase 3 studies.
Yes, the IDP-118 clinical program used randomized, double-blind, active-controlled designs. The trials enrolled adults aged 18 years and older of all sexes, and the completed studies together included 1,185 participants with plaque psoriasis or psoriasis, all conducted at sites in the United States.