Abrocitinib Dose Tapering in Patients With Atopic Dermatitis

NCT07848074 | Not Yet Recruiting Phase 4

• 1 other identifier: 27976
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective, multicenter study aims to evaluate whether patients with moderate-to-severe atopic dermatitis who achieve optimal disease control during treatment with abrocitinib 200 mg once daily can maintain disease control following dose reduction to 100 mg once daily. Adult patients who have achieved Minimal Disease Activity (MDA) at two consecutive visits at least one month apart will undergo abrocitinib dose tapering from 200 mg/day to 100 mg/day. Patients will be evaluated at Weeks 4, 16, and 32 after dose reduction. The primary objective is to determine the proportion of patients maintaining MDA following dose tapering and to explore clinical factors associated with successful maintenance of disease control. Additional outcomes include changes in disease severity, itch, sleep disturbance, quality of life, treatment adherence, involvement of difficult-to-treat anatomical areas, use of topical therapies, and treatment safety and tolerability.

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis; abrocitinib

Outcome Measures

Primary Outcomes (2)

• Proportion of Participants Maintaining Minimal Disease Activity at Week 16

  Proportion of participants who maintain Minimal Disease Activity (MDA) 16 weeks after abrocitinib dose reduction from 200 mg/day to 100 mg/day without dose re-escalation. MDA is defined as the concurrent achievement of at least one predefined clinician-reported optimal target (EASI ≤3 or EASI-90) and at least one predefined patient-reported optimal target (peak pruritus NRS ≤1, sleep NRS ≤1, or DLQI 0-1).

  16 weeks after dose tapering

• Proportion of Participants Maintaining Minimal Disease Activity at Week 32

  Proportion of participants who maintain Minimal Disease Activity (MDA) 32 weeks after abrocitinib dose reduction from 200 mg/day to 100 mg/day without dose re-escalation. MDA is defined as the concurrent achievement of at least one predefined clinician-reported optimal target (EASI ≤3 or EASI-90) and at least one predefined patient-reported optimal target (peak pruritus NRS ≤1, sleep NRS ≤1, or DLQI 0-1).

  32weeks after dose tapering

Secondary Outcomes (2)

• Change in Eczema Area and Severity Index

  Baseline and Weeks 4, 16, and 32

• Maintenance of EASI-50, EASI-75, and EASI-90 Responses

  week 4,16,32

Study Arms (1)

abrocitinib dose tapering

EXPERIMENTAL

Participants with atopic dermatitis who have achieved sustained Minimal Disease Activity while receiving abrocitinib 200 mg once daily will undergo dose reduction to abrocitinib 100 mg once daily at study baseline. Participants will be followed at Weeks 4, 16, and 32 after dose tapering. In case of clinically relevant loss of disease control, the abrocitinib dose may be re-escalated to 200 mg once daily according to physician judgment.

Drug: Abrocitinib

Interventions

Abrocitinib DRUG

Participants who have achieved sustained Minimal Disease Activity while receiving abrocitinib 200 mg once daily will undergo dose reduction to abrocitinib 100 mg once daily at study baseline. Treatment with abrocitinib 100 mg once daily will be continued during follow-up. In case of clinically relevant loss of disease control, the dose may be re-escalated to 200 mg once daily according to physician judgment.

abrocitinib dose tapering

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years. Diagnosis of atopic dermatitis according to Hanifin and Rajka criteria for at least 6 months.
• Moderate-to-severe atopic dermatitis meeting applicable criteria for systemic treatment.
• Receiving abrocitinib 200 mg once daily for at least 3 months. Achievement of Minimal Disease Activity at two consecutive visits at least one month apart; the second visit will constitute the baseline visit for study enrollment and dose tapering.
• Ability to provide written informed consent. Ability and willingness to attend scheduled study visits. -

You may not qualify if:

• Presence of another skin disease that may interfere with the diagnosis or clinical assessment of atopic dermatitis.
• Concomitant treatment with systemic immunosuppressive or immunomodulatory therapy for another inflammatory or autoimmune condition.
• Inability to provide informed consent. Inability or unwillingness to attend scheduled follow-up visits.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

abrocitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Ketty Peris

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ketty Peris, Prof

CONTACT

+390630157258; ketty.peris@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All enrolled participants who have achieved sustained Minimal Disease Activity during treatment with abrocitinib 200 mg/day will undergo dose reduction to abrocitinib 100 mg/day and will be followed prospectively for 32 weeks.

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 29, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09