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NCT05601882 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 920
- Enrollment target
NCT05601882 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 920 participants.
The verdict
NCT05601882, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 920 participants
- Enrollment target
Study Summary
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who have inadequate response to systemic therapies. Adverse events and change in the disease activity will be assessed. Upadacitinib and dupilumab are approved drugs for the treatment of moderate to severe atopic dermatitis (AD). The study is comprised of a 35-day Screening Period, a 16-week treatment Period 1 and a 16-week treatment Period 2. Participants are randomly assigned to 1 of 2 groups called treatment arms to receive upadacitinib Dose A or dupilumab in Period 1. There is a 30-day or 12-week follow-up visit for those on upadacitinib or dupilumab respectively, who will not enter Period 2. In Period 2, participants will receive upadacitinib Dose A or Dose B for 16 weeks, followed by a 30-day follow-up visit. Approximately 880 adolescent and adult participants ages 12 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 330 sites worldwide. There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Interventions
- DRUG Dupilumab
- DRUG Upadacitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 920 participants |
| Start Date | 2022-11-28 |
| Est. Completion | 2024-08-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05601882
The ClinicalTrials.gov registry entry for NCT05601882 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 920 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Dupilumab is the first listed.
NCT05601882 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05601882 about?
NCT05601882 is a clinical study titled "A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis". Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study compares upadacitinib to dupilumab in ad...
What is the current status of trial NCT05601882?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 920 participants. The study started on 2022-11-28. Estimated completion is 2024-08-08.
What interventions are being tested in trial NCT05601882?
The interventions under investigation include: Dupilumab (DRUG), Upadacitinib (DRUG).
Who is sponsoring clinical trial NCT05601882?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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