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Also known as Dupilumab 300mg Dose, Dupilumab Dose
Dupilumab · 1 trial · 1 indication
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch).
| Arm | Type | Description |
|---|---|---|
| Dupilumab (Period 1) | EXPERIMENTAL | Adult participants received a loading dose of 600 mg dupilumab by subcutaneous (SC) injection at the Baseline visit followed by 300 mg dupilumab SC every other week (EOW) until Week 16. Adolescents (12 to 17 years of age and weighing at least 40 kg) received treatment according to their body weight. Participants weighing 40 to \< 60 kg received a loading dose of 400 mg dupilumab SC at the Baseline visit followed by 200 mg SC EOW until Week 16. Those weighing 60 kg or more received a loading dose of 600 mg dupilumab SC at the Baseline visit followed by 300 mg dupilumab SC EOW until Week 16. |
| Upadacitinib (Period 1) | EXPERIMENTAL | Participants received 15 mg upadacitinib orally once a day (QD) up to Week 16. Starting at Week 4, participants had their dose increased to 30 mg QD if they had a \< 50% reduction from Baseline in Eczema Area and Severity Index (EASI 50) response or a \< 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average). Starting at Week 8, participants had their dose increased to 30 mg QD if they had a \< EASI 75 response. |
| Dupilumab -> Upadacitinib (Period 2) | EXPERIMENTAL | At Week 16, participants receiving dupilumab as per its label in Period 1 were reassigned based on their Eczema Area and Severity Index (EASI) response. Those with \< EASI 75 were offered the option to receive oral doses of upadacitinib 15 mg QD in Period 2 up to Week 32. Those with ≥ EASI 75 completed the end of study procedures. Starting at Week 20, participants with \< EASI 75 or a \< 4-point improvement from Baseline in Worst Pruritus Numerical Rating Scale (WP-NRS; weekly average) had their dose increased to 30 mg QD up to Week 32. |
| Upadacitinib -> Upadacitinib 30 mg (Period 2) | EXPERIMENTAL | At Week 16, participants receiving upadacitinib in Period 1 were reassigned based on their Eczema Area and Severity Index (EASI) response. Those with \< EASI 75 were allocated or continued to receive upadacitinib 30 mg QD in Period 2. Those with ≥ EASI 75 completed the end of study procedures. |
| Name | Type | Description |
|---|---|---|
| Dupilumab | DRUG | Dupilumab is administered as a subcutaneous (SC) injection. |
| Upadacitinib | DRUG | Extended-release tablet |
Inclusion Criteria: * Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to baseline and participant meets Hanifin and Rajka criteria. * Eczema area and severity index (EASI) score ≥ 16;validated Investigator´s Global Assessment for AD (vIGA-AD) score ≥ 3 and ≥ 10% Body Su...
Top 20 of 25 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 9 | PHASE3 | Upadacitinib, corticosteroids |
| Pfizer Inc. | PFE | 11 | PHASE3 | Abrocitinib |
| Eli Lilly and Company | LLY | 4 | PHASE3 | Lebrikizumab, Corticosteroid |
| Sanofi SA Sponsored ADR | SNY | 13 | PHASE3 | Amlitelimab |
| Regeneron Pharmaceuticals, Inc. | REGN | 4 | PHASE3 | Dupilumab |
| Incyte Corporation | INCY | 3 | PHASE3 | Ruxolitinib, Vehicle |
| Organon & Co. | OGN | 1 | PHASE3 | Tapinarof, 1%, Vehicle |
| Apogee Therapeutics, Inc. | APGE | 3 | PHASE2 | APG777 |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | GIA632 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Corvus Pharmaceuticals, Inc. | CRVS | 1 | PHASE2 | Soquelitinib |
| Nektar Therapeutics | NKTR | 1 | PHASE2 | Rezpegaldesleukin |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE2 | Barzolvolimab |
| Evommune, Inc. | EVMN | 1 | PHASE2 | EVO756 |
| Sunshine Biopharma Incorporated | SBFM | 3 | PHASE3 | 611, corticosteroid |
| Aclaris Therapeutics, Inc. | ACRS | 1 | PHASE2 | ATI-045 |
| Q32 Bio Inc | QTTB | 1 | PHASE2 | ADX-914 |
| Turn Therapeutics Inc. | TTRX | 1 | PHASE2 | GX-03 |
| Arcutis Biotherapeutics Inc | ARQT | 1 | PHASE1 | ARQ-234 |
Dupilumab is an investigational biologic being studied for the treatment of moderate to severe atopic dermatitis in adolescent and adult participants. It is administered subcutaneously and is currently in Phase 3 clinical development. The drug has received Breakthrough Therapy designation from the FDA.
Dupilumab is a monoclonal antibody, classified as a -mab (antibody) modality. It is being evaluated for its ability to modulate disease activity in atopic dermatitis. The specific molecular target is not disclosed in the available clinical trial information.
Dupilumab is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with moderate to severe atopic dermatitis.
Dupilumab is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug has received Breakthrough Therapy designation from the FDA, which is intended to expedite the development and review of drugs for serious conditions.
Dupilumab is being studied in clinical trial NCT05601882, a Phase 3 study comparing oral upadacitinib to subcutaneous dupilumab in adolescent and adult participants with moderate to severe atopic dermatitis. The trial has been completed and enrolled 920 participants across multiple countries.
Yes, Dupilumab is also known as Dupilumab 300mg Dose and Dupilumab Dose. These alternative names refer to the same drug product being investigated for the treatment of moderate to severe atopic dermatitis.