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Arcutis Biotherapeutics, Inc. (ARQT)

Arcutis Biotherapeutics, Inc. is a biopharmaceutical firm dedicated to developing and marketing therapies for a range of skin-related diseases. The company's flagship investigational compound, ARQ-151, a roflumilast cream administered topically, has successfully concluded late-stage clinical development for treating both plaque psoriasis and atopic dermatitis. Beyond its lead asset, Arcutis's pipeline includes several other promising compounds. Among these is ARQ-154, a roflumilast foam applied topically, aimed at seborrheic dermatitis and scalp psoriasis. Furthermore, ARQ-252, a topical selective Janus kinase type 1 (JAK1) inhibitor, is under investigation for hand eczema and vitiligo. ARQ-255, a variation of ARQ-252 designed for deeper dermal absorption, is being explored for alopecia areata. Established in 2016, the company was initially named Arcutis, Inc. before changing to Arcutis Biotherapeutics, Inc. in October 2019. Its corporate headquarters are situated in Westlake Village, California.

Sector: Pharmaceutical Preparations

Industry: Biotechnology

Arcutis Biotherapeutics, Inc. logo

Arcutis Biotherapeutics, Inc.

NASDAQ:ARQTHealthcare
+0.31%$32.07
AH$31.82-0.78%vs close
Mkt Cap$4.03B
Float113.54M
O/S125.69M
Vol
$ Vol
RVOL
Inst Own-
SI18.0%
Earnings
Dilution
Arcutis Biotherapeutics, Inc. logoNASDAQ:ARQT$32.07+0.31%
Upcoming Catalysts
Phase Distribution
25 lead-sponsored trials·1 active·23 completed
Phase 14
Phase 1/22
Phase 210
Phase 39
(4 more as collaborator)

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 3
    Completed

    Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

    Roflumilast 0.3% cream, Vehicle Cream

    Chronic Plaque Psoriasis

    Enrollment
    439
    Start
    Dec 2019
    Primary Completion
    Nov 2020
    Completion
    Nov 2020
    NCT04211363
  • Phase 3
    Completed

    Twin Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

    ARQ-151 0.3% cream, ARQ-151 vehicle cream

    Chronic Plaque Psoriasis

    Enrollment
    442
    Start
    Dec 2019
    Primary Completion
    Nov 2020
    Completion
    Nov 2020
    NCT04211389
  • Phase 3
    Completed

    Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

    Topical roflumilast

    Chronic Plaque Psoriasis

    Enrollment
    337
    Start
    Feb 2020
    Primary Completion
    Jan 2024
    Completion
    Jan 2024
    NCT04286607
  • Phase 3
    Completed

    Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis

    Roflumilast Cream 0.15%, Vehicle Cream

    Atopic Dermatitis Eczema

    Enrollment
    654
    Start
    Jan 2021
    Primary Completion
    Aug 2022
    Completion
    Aug 2022
    NCT04773587
  • Phase 3
    Completed

    Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II)

    Roflumilast Cream, Vehicle cream

    Atopic Dermatitis Eczema

    Enrollment
    683
    Start
    Feb 2021
    Primary Completion
    Sep 2022
    Completion
    Sep 2022
    NCT04773600
  • Phase 3
    Completed

    Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis

    ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%

    Atopic Dermatitis Eczema

    Enrollment
    1,220
    Start
    Feb 2021
    Primary Completion
    May 2024
    Completion
    May 2024
    NCT04804605
  • Phase 3
    Completed

    Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)

    Roflumilast Cream 0.05%, Vehicle Cream

    Atopic Dermatitis Eczema

    Enrollment
    652
    Start
    Apr 2021
    Primary Completion
    Jun 2023
    Completion
    Jun 2023
    NCT04845620
  • Phase 3
    Completed

    Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM)

    Roflumilast Foam, Vehicle Foam

    Seborrheic Dermatitis

    Enrollment
    457
    Start
    Jul 2021
    Primary Completion
    Apr 2022
    Completion
    Apr 2022
    NCT04973228
  • Phase 3
    Completed

    Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR)

    Roflumilast Foam 0.3%, Vehicle Foam

    Scalp Psoriasis

    Enrollment
    432
    Start
    Aug 2021
    Primary Completion
    Jun 2022
    Completion
    Jun 2022
    NCT05028582
  • Phase 2
    Completed

    The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis

    Roflumilast Cream 0.3%, Roflumilast Cream 0.15%

    Plaque Psoriasis

    Enrollment
    331
    Start
    Sep 2018
    Primary Completion
    May 2019
    Completion
    May 2019
    NCT03638258
  • Phase 2
    Completed

    Long-Term Safety of ARQ-151 Cream in Adult Subjects With Chronic Plaque Psoriasis

    Roflumilast

    Plaque Psoriasis

    Enrollment
    332
    Start
    Dec 2018
    Primary Completion
    Oct 2020
    Completion
    Oct 2020
    NCT03764475
  • Phase 2
    Completed

    Safety and Efficacy of ARQ-151 Cream in Adolescents and Adults With Atopic Dermatitis

    Roflumilast Cream 0.05%, Roflumilast Cream 0.15%

    Atopic Dermatitis

    Enrollment
    136
    Start
    May 2019
    Primary Completion
    Nov 2019
    Completion
    Nov 2019
    NCT03916081
  • Phase 2
    Completed

    Safety and Efficacy of ARQ-154 Foam in Subjects With Seborrheic Dermatitis

    Roflumilast Foam 0.3%, Vehicle foam

    Seborrheic Dermatitis

    Enrollment
    226
    Start
    Dec 2019
    Primary Completion
    Aug 2020
    Completion
    Aug 2020
    NCT04091646
  • Phase 2
    Completed

    Safety and Efficacy of ARQ-154 Foam in Adolescent and Adult Subjects With Scalp and Body Psoriasis

    Roflumilast foam 0.3%, Vehicle foam

    Plaque Psoriasis

    Enrollment
    304
    Start
    Jan 2020
    Primary Completion
    Sep 2020
    Completion
    Sep 2020
    NCT04128007
  • Phase 2
    Completed

    Long-Term Safety of ARQ-154 Foam in Subjects With Seborrheic Dermatitis

    ARQ-154

    Seborrheic Dermatitis

    Enrollment
    408
    Start
    Jun 2020
    Primary Completion
    Nov 2022
    Completion
    Nov 2022
    NCT04445987
  • Phase 2
    Completed

    Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-215)

    ARQ-151 cream 0.3%

    Psoriasis, Plaque Psoriasis

    Enrollment
    20
    Start
    Nov 2020
    Primary Completion
    Jan 2022
    Completion
    Jan 2022
    NCT04655313
  • Phase 2
    Completed

    Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-216)

    ARQ-151 cream 0.3%

    Psoriasis, Plaque Psoriasis

    Enrollment
    10
    Start
    Mar 2021
    Primary Completion
    May 2022
    Completion
    May 2022
    NCT04746911
  • Phase 2
    Terminated

    Safety and Efficacy of ARQ-252 Cream 0.3% in Subjects With Non-Segmental Facial Vitiligo

    ARQ-252 cream 0.3%, ARQ-252 Vehicle cream

    Vitiligo

    Enrollment
    114
    Start
    Mar 2021
    Primary Completion
    Aug 2021
    Completion
    Aug 2021
    NCT04811131
  • Phase 2
    Completed

    Safety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis

    ARQ-151 cream 0.05%

    Atopic Dermatitis (Eczema)

    Enrollment
    101
    Start
    Jun 2025
    Primary Completion
    Dec 2025
    Completion
    Dec 2025
    NCT06998056
  • Phase 1/2
    Completed

    Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream in Adults With Mild to Moderate Chronic Plaque Psoriasis

    ARQ-151 cream 0.5%, ARQ-151 cream 0.15%

    Psoriasis

    Enrollment
    91
    Start
    Dec 2017
    Primary Completion
    May 2018
    Completion
    May 2018
    NCT03392168
  • Phase 1/2
    Completed

    Safety and Efficacy of ARQ-252 Cream in Subjects With Chronic Hand Eczema

    ARQ-252 cream 0.3%, ARQ-252 cream 0.1%

    Chronic Hand Eczema

    Enrollment
    230
    Start
    Apr 2020
    Primary Completion
    Feb 2021
    Completion
    Feb 2021
    NCT04378569
  • Phase 1
    Completed

    Pharmacokinetics (PK), Safety, Efficacy and Maximal Use PK of ARQ-151 in Adolescents/Children With Mild/Moderate Eczema

    ARQ-151 cream 0.15%, ARQ-151 cream 0.05%

    Atopic Dermatitis (Eczema)

    Enrollment
    101
    Start
    Dec 2019
    Primary Completion
    May 2023
    Completion
    May 2023
    NCT04156191
  • Phase 1
    Completed

    Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Adolescents and Adults With Chronic Plaque Psoriasis

    ARQ-151- cream 0.3%

    Plaque Psoriasis

    Enrollment
    26
    Start
    Mar 2020
    Primary Completion
    Mar 2021
    Completion
    Mar 2021
    NCT04279119
  • Phase 1
    Completed

    Maximal Usage Pharmacokinetics and Safety Study of ARQ-154 Foam 0.3% in Pediatric Participants With Scalp and Body Psoriasis

    ARQ-154 Foam 0.3%

    Psoriasis

    Enrollment
    22
    Start
    Dec 2025
    Primary Completion
    Apr 2026
    Completion
    Apr 2026
    NCT07340216
  • Phase 1
    Recruiting

    Ph 1a/1b Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234

    ARQ-234, Placebo

    Atopic Dermatitis (AD), Eczema

    Enrollment
    125
    Start
    Mar 2026
    Primary Completion
    Apr 2028est.
    Completion
    Apr 2028est.
    NCT07453602
Search ClinicalTrials.gov for “Arcutis Biotherapeutics”