Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Roflumilast, Roflumilast Cream 0.3%, Roflumilast 0.3%, Roflumilast 0.15%, Roflumilast Cream 0.05%, Roflumilast 0.05%, Roflumilast 0.3% cream, Topical roflumilast
Roflumilast cream 0.15% · 8 trials · 4 indications
The percentage of participants with vIGA-AD success at Week 4 is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity. vIGA success was defined as score of 'clear' or 'almost clear' plus a 2-grade improvement from baseline.
The percentage of participants with ≥TEAE is reported.
The percentage of participants with ≥1 SAE is reported.
The number of participants achieving "success" in IGA assessment of disease severity at Week 8 is presented (observed data only) for each arm. Success was defined as achievement of an IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is a 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.
The least squares (LS) mean (SD) change from baseline in EASI Total Score at Week 4 is reported. The EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). The EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (maximal disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.
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 0.05% | EXPERIMENTAL | Participants applied roflumilast cream 0.05% qd for 4 weeks. |
| Vehicle Cream | PLACEBO_COMPARATOR | Participants applied vehicle cream qd for 4 weeks. |
| Roflumilast Cream 0.15% | EXPERIMENTAL | Participants apply roflumilast cream 0.15% once daily (qd) for 4 weeks. |
| ARQ-151 Cream 0.3% | EXPERIMENTAL | - |
| Rofumilast Cream 0.3% | EXPERIMENTAL | Participants receive roflumilast cream 0.3% once daily for 8 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 0.05% | DRUG | Roflumilast cream for topical application. |
| Vehicle Cream | DRUG | Vehicle cream matched to roflumilast cream for topical application. |
| Roflumilast Cream | DRUG | Roflumilast cream 0.15% for topical application |
| Roflumilast Cream 0.15% | DRUG | Roflumilast Cream 0.15% - Active |
| Topical roflumilast | DRUG | Active treatment |
| Roflumilast 0.3% cream | DRUG | Roflumilast 0.3% cream for topical application. |
| Roflumilast | DRUG | Roflumilast cream 0.3% for topical application |
| Roflumilast Cream 0.3% | DRUG | Applied once daily for 12 weeks |
Inclusion Criteria: 1. Informed consent by parent(s) or legal guardian as required by local laws. 2. Males and females, ages 2 to 5 years old at time of signing Informed Consent (Screening) and at Baseline (Day 1). 3. Diagnosed with atopic dermatitis for at least 6 weeks, as determined by the Inves...
Roflumilast is a topical small molecule developed for dermatology indications including atopic dermatitis eczema, chronic plaque psoriasis, and plaque psoriasis. It is being studied as a cream in multiple strengths, including 0.3%, 0.15%, and 0.05%, for inflammatory skin conditions. Arcutis Biotherapeutics is developing it under the ticker ARQT.
Roflumilast targets phosphodiesterase 4, or PDE4. By inhibiting PDE4, the drug is designed to reduce cyclic AMP breakdown in inflammatory cells, which is the mechanism explored in its dermatology trials. Trial titles describe the program as PDE4 inhibition with roflumilast for the management of atopic dermatitis and plaque psoriasis.
Roflumilast is developed by Arcutis Biotherapeutics, Inc., which trades under the ticker ARQT. The company is advancing topical roflumilast cream formulations across dermatology indications, including atopic dermatitis eczema and chronic plaque psoriasis. The program includes multiple Phase 3 trials conducted in the United States and Canada.
Roflumilast is in Phase 3 development for its dermatology indications. The program includes completed Phase 3 trials in atopic dermatitis eczema and chronic plaque psoriasis, along with completed Phase 2 work in plaque psoriasis. It has received a Fast Track designation from the FDA and remains in clinical development.
Roflumilast has been studied in completed trials including NCT04773600, the Phase 3 INTEGUMENT-II trial in atopic dermatitis eczema with 683 participants, and NCT04286607, a Phase 3 open-label extension in chronic plaque psoriasis with 337 participants. NCT04211363 was a Phase 3 plaque psoriasis trial with 439 participants, and NCT03764475 was a Phase 2 long-term safety study with 332 participants.
Yes. Roflumilast cream 0.3%, roflumilast 0.3%, roflumilast cream 0.15%, roflumilast 0.15%, roflumilast cream 0.05%, roflumilast 0.05%, and topical roflumilast all refer to the same topical roflumilast program. The different numbers indicate the cream strength being evaluated in the dermatology trials.