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 administered as a lotion and is currently in Phase 3 clinical development. The drug is being studied in adult patients with plaque psoriasis in the United States.
IDP-118 is being developed by Bausch Health Companies Inc., a company traded on the New York Stock Exchange under the ticker symbol BHC. The company is conducting clinical trials of IDP-118 for the treatment of plaque psoriasis in the United States.
IDP-118 is in Phase 3 clinical development for the treatment of plaque psoriasis. It is an investigational drug, meaning it has not been approved by regulatory authorities. Four clinical trials have been completed, including three Phase 3 studies and one Phase 2 study.
IDP-118 has been studied in four completed clinical trials for plaque psoriasis. These include NCT02045277, a Phase 2 study with 212 participants, and three Phase 3 studies: NCT02462070 with 203 participants, NCT02462083 with 555 participants, and NCT02462122 with 215 participants. All trials were conducted in the United States.
Yes, IDP-118 clinical trials are randomized, double-blind, and active-controlled. This means participants are randomly assigned to receive either IDP-118 or an active comparator, and neither the participants nor the investigators know which treatment is being administered. This design is used to evaluate the safety and efficacy of the drug.
A total of 1,185 participants have been enrolled across the four completed clinical trials of IDP-118 for plaque psoriasis. The trials enrolled adults aged 18 years and older, with no healthy volunteers included. All studies were conducted in the United States.