Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Roflumilast Foam 0.3% · 5 trials · 3 indications
The IGA is a static evaluation of qualitative overall seborrheic dermatitis severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4). IGA success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement.
The percentage of participants with S-IGA success at Week 8 is presented. Success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement from baseline at Week 8. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4), with higher scores indicative of greater symptom severity.
The percentage of participants with B-IGA success at Week 8 is presented. Success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement from baseline at Week 8. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2),Moderate (3), Severe (4), with higher scores indicative of greater symptom severity.
The percentage of participants achieving IGA "success" is presented. Success is defined as a score of 0 ('clear') or 1 ('almost clear') plus a 2-point improvement at Week 8. The IGA is 5-point scale assessing the severity of seborrheic dermatitis with total scores ranging from 0 ('clear') to 4 ('severe') \[higher scores indicating greater severity\].
The number of participants achieving success in the S-IGA scale is presented for each arm. Success is defined as an S-IGA score of 0 ('clear') or 1 ('almost clear'), plus a 2-grade improvement from baseline.The S-IGA is 5-point scale assessing the severity of plaque psoriasis on the scalp, with scores ranging from 0 ('clear') to 4 ('severe'). Higher scores indicate greater symptom severity.
The number of participants achieving "success" in IGA assessment of disease severity at Week 8 is presented for each arm. Success was defined as achievement of an IGA score of 0 ('completely clear') or 1 ('almost clear'), accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is 5-point scale assessing the severity of Seborrheic Dermatitis, with scores ranging from 0 ('completely clear') to 4 ('severe'), and higher scores indicate greater severity. The IGA scores are based on observed data, whereas odds ratio and p-values were calculated using multiple imputation of missing values.
| Arm | Type | Description |
|---|---|---|
| Roflumilast foam 0.3% | EXPERIMENTAL | - |
| Vehicle foam | PLACEBO_COMPARATOR | - |
| ARQ-154 foam 0.3% | EXPERIMENTAL | active |
| ARQ foam VehicleRQ-154 foam Vehicle | PLACEBO_COMPARATOR | placebo |
| Name | Type | Description |
|---|---|---|
| Roflumilast Foam 0.3% | DRUG | Roflumilast foam 0.3% is applied once daily for 8 weeks. |
| Vehicle foam | DRUG | Vehicle foam is applied once daily for 8 weeks. |
| Roflumilast Foam | DRUG | Roflumilast 0.3% foam for topical application |
Inclusion Criteria: 1. Males and females ages 9 years and older (inclusive) at the time of consent. 2. Clinical diagnosis of seborrheic dermatitis of at least 3 months duration at screening as determined by the Investigator. Stable disease for the past 4 weeks. 3. Seborrheic dermatitis up to 20% BS...
Roflumilast Foam 0.3% is an investigational topical foam being developed for the treatment of scalp psoriasis, seborrheic dermatitis, and plaque psoriasis. It is a small molecule in the dermatology therapeutic area, currently in Phase 3 clinical development.
Roflumilast Foam 0.3% targets the PDE4 enzyme, which plays a role in inflammatory processes. By inhibiting PDE4, the drug aims to reduce inflammation associated with scalp psoriasis, seborrheic dermatitis, and plaque psoriasis.
Roflumilast Foam 0.3% is being developed by Arcutis Biotherapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker ARQT. The company is focused on developing innovative dermatology treatments.
Roflumilast Foam 0.3% is in Phase 3 clinical development. It has received Fast Track designation from the FDA. The drug is investigational and not yet approved, with ongoing clinical trials evaluating its safety and efficacy.
Roflumilast Foam 0.3% has been studied in several clinical trials, including NCT04091646 (Phase 2 for seborrheic dermatitis), NCT04128007 (Phase 2 for plaque psoriasis), NCT04973228 (Phase 3 for seborrheic dermatitis, known as STRATUM), and NCT05028582 (Phase 3 for scalp psoriasis, known as ARRECTOR).
Yes, Roflumilast Foam 0.3% is also known as ARQ-154. Clinical trials have used the ARQ-154 designation, such as NCT04091646 and NCT04128007, to refer to the same investigational drug.