RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Abrocitinib for Atopic Dermatitis

Q: Is NCT06807281 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

Q: What phase is NCT06807281?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT06807281?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

This 24-month study will assess the long-term safety and how well it works of liquid abrocitinib oral suspension with or without topical medications in children 2 years of age or older with moderate-to-severe atopic dermatitis. The study will enroll two groups: participants who have completed other abrocitinib studies and participants who have never participated in abrocitinib studies.

Official registry: https://clinicaltrials.gov/study/NCT06807281 · Pfizer · enrollment listed as 450

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Abrocitinib. The registry lists allocation as randomized. This 24-month study will assess the long-term safety and how well it works of liquid abrocitinib oral suspension with or without topical medications in children 2 years of age or older with moderate-to-severe atopic dermatitis.

They plan to enroll about 450 people at 40 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 3, Multicenter, Long-Term, Open Label Study Evaluating the Safety and Efficacy of Abrocitinib, With or Without Topical Medications Administered to Pediatric Participants Aged 2 Years and Older With Moderate-to-Severe Atopic Dermatitis

Interventions: Abrocitinib

Primary outcome (registry wording): Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events (AEs) that lead to study discontinuation

Who it is for (from inclusion criteria)

Ages 2 Years to 11 Years
for the Extension Cohort:
1\. Participants who have completed the treatment phase of the qualifying parent study (age 2 to \<12 years old)
who can join for the De Novo Cohort:
No contraception methods are required for male participants
Disease Characteristics:
Participants who meet all of the following AD criteria:
A documented diagnosis of chronic AD for at least 6 months prior to screening and confirmed at screening and baseline visits according to the Hanifin and Rajka criteria; and

Who the registry excludes

for the Extension Cohort:
Medical Conditions:
If the participant has SDQ total score ≥17, the investigator should exclude the child or refer them to a pediatric MHP to determine if it is safe to participate in the study. A copy or summary of the evaluation should be placed in the site source documents
Prior/Concomitant Therapy:
Required use of any prohibited concomitant treatments outlined in Section 6.9.3 and Appendix 9 of study protocol
Required vaccination with live attenuated vaccines during study treatment and for 6 weeks after discontinuing study treatment
Diagnostic Assessments:

Public study contact (from the registry)

Pfizer CT.gov Call Center

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

40 listed

Cahaba Dermatology & Skin Health Center — Birmingham, Alabama (recruiting)
Arkansas Research Trials — North Little Rock, Arkansas (recruiting)
Investigational Drug Service - Rady Childrens Hospital-San Diego — San Diego, California (recruiting)
University of California, San Diego/ Rady Children's Hospital - San Diego — San Diego, California (recruiting)
Solutions Through Advanced Research — Jacksonville, Florida (recruiting)
Ada West Research - Meridian — Meridian, Idaho (recruiting)
Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana (recruiting)
Saint Louis University — St Louis, Missouri (recruiting)
Medical University of South Carolina - South Carolina Translational Research Nexus Clinic — Charleston, South Carolina (recruiting)
Tribe Clinical Research, LLC — Greenville, South Carolina (recruiting)
Texas Dermatology and Laser Specialists — San Antonio, Texas (recruiting)

+ 29 sites outside the US on the same record

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phasePittsburgh, Pennsylvania

Not a traditional drug phase: Blood draw, skin biopsy or urine collection for Cutaneous T-cell Lymphoma

This is a tissue, urine, and blood banking protocol for cutaneous t-cell lymphoma (CTCL), eczema, and atopic dermatitis patients for current and future research.

NCT00177268 · Official ClinicalTrials.gov record · University of Pittsburgh

RecruitingNot a traditional drug phaseBethesda, Maryland

Studies of Skin Microbes in Healthy People and in People With Skin Conditions

This study will examine microbes (e.g., bacteria, fungi, viruses) that live on human skin and how microbes contribute to health and disease. It will analyze healthy human skin and how the these microorganisms might change in patients with atopic dermatitis (AD), a skin condition also known as eczema.

NCT00605878 · Official ClinicalTrials.gov record · National Human Genome Research Institute (NHGRI)

RecruitingPhase 2Bethesda, Maryland

Phase 2: testing Trimethoprim/sulfamethoxazole (TMP/SMZ) for Eczema

Background: \- Atopic dermatitis, or eczema, is a chronic skin disorder. Patients sometimes have infections with S.

NCT01631617 · Official ClinicalTrials.gov record · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

FAQ about this NCT record

Is NCT06807281 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06807281?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06807281?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary