Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Roflumilast · 3 trials · 2 indications
The percentage of participants achieving viGA-AD "success" is presented with multiple imputation of missing observations. viGA-AD "success" is defined as a viGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The viGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear), with higher scores indicative of greater symptom severity.
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AEs that began after initiating study treatment (treatment-emergent AEs \[TEAEs\]) in ARQ-151-202 are presented.
An SAE is any AE that in the view of either the PI or Sponsor, results in any of the following outcomes: Death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
The percentage of participants with an IGA score of 0 ('clear') or 1 ('almost clear') at Week 6 is reported. The IGA is 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater plaque severity.
| Arm | Type | Description |
|---|---|---|
| Roflumilast Cream 0.15% | EXPERIMENTAL | Participants apply roflumilast cream 0.15% once daily (qd) for 4 weeks. |
| Vehicle Cream | PLACEBO_COMPARATOR | Participants apply vehicle cream qd for 4 weeks. |
| Long-term Safety of Roflumilast | OTHER | Participants applied roflumilast (ARQ-151) cream 0.3% once daily for 52 weeks |
| Roflumilast Cream 0.3% | EXPERIMENTAL | Roflumilast cream 0.3% topically applied QD for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Roflumilast Cream | DRUG | Roflumilast cream 0.15% for topical application |
| Vehicle cream | DRUG | Vehicle cream for topical application |
| Roflumilast | DRUG | Roflumilast cream 0.3% for topical application |
| Roflumilast Cream 0.3% | DRUG | Applied once daily for 12 weeks |
| Roflumilast Cream 0.15% | DRUG | Applied once daily for 12 weeks |
Inclusion Criteria: 1. Participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws. 2. Males and females, ages 6 years and older at time of signing Informed Consent (Screening). Only subjects 18 years and older will be enrolled at sites loc...
Roflumilast is a small molecule being developed by Arcutis Biotherapeutics for chronic plaque psoriasis, atopic dermatitis (eczema), and plaque psoriasis. It is currently in Phase 3 clinical development for these dermatological indications and has received Fast Track designation from the FDA.
Roflumilast works by inhibiting the PDE4 enzyme, which is involved in inflammatory processes. By blocking PDE4, roflumilast reduces the production of pro-inflammatory cytokines, thereby helping to manage inflammatory skin conditions like plaque psoriasis and atopic dermatitis.
Roflumilast is being developed by Arcutis Biotherapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ARQT. The company is focused on developing dermatological therapies.
Roflumilast is in Phase 3 clinical development. It has completed two Phase 3 trials, including one for chronic plaque psoriasis and one for atopic dermatitis, and has received Fast Track designation from the FDA for these indications.
Roflumilast has been studied in several completed clinical trials. Notable ones include NCT04211363, a Phase 3 trial for chronic plaque psoriasis with 439 participants, and NCT04773600, a Phase 3 trial for atopic dermatitis with 683 participants. Both trials were conducted in the United States and Canada.
Yes, Roflumilast is the same as ARQ-151. In clinical trials, the drug was referred to as ARQ-151 cream, as seen in studies like NCT03638258 and NCT03764475, which evaluated its safety and efficacy in subjects with chronic plaque psoriasis.