The Safety and Efficacy of Upadacitinib in Refractory Autoimmune Related Cholangitis and Atopic Dermatitis With Moderate to Severe Itching

Sponsor
RenJi Hospital
Study ID
NCT07678645
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Atopic Dermatitis (AD)
  • Primary Biliary Cholangitis (PBC)
  • Primary Sclerosing Cholangitis (PSC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Upadacitinib 15 MG — DRUG
    This is a single-arm, open-label, fixed-dose exploratory clinical trial. All eligible subjects who meet the inclusion and exclusion criteria will receive a uniform, fixed-dose regimen of upadacitinib in combination with background therapy, without a concurrent control group. The administered dose is 15 mg once daily (QD), which falls within the recommended dose range for atopic dermatitis as approved in the upadacitinib Chinese package insert (product labeling). This study will not investigate alternative dosage regimens, nor will it evaluate the efficacy or safety of off-label dose levels.

Study Details

Cholestatic liver diseases are characterized by jaundice, pruritus, and elevated levels of alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT). Primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC) represent the major autoimmune-driven entities within this category. Without effective intervention, these conditions may progress to liver failure and even death. Ursodeoxycholic acid (UDCA), the first-line therapy for PBC, has been shown to improve prognosis; however, 20%-40% of patients exhibit an inadequate biochemical response. For PSC, no clearly effective pharmacologic agent is currently available. In refractory patients, pruritus often progressively worsens, severely impairing quality of life and treatment adherence, underscoring an urgent need for novel therapeutic approaches that simultaneously address disease control and itch relief. Autoimmune-associated cholangitis frequently coexists with atopic dermatitis, and in a subset of patients, pruritus may be compounded by dermatologic factors. The pruritus of atopic dermatitis involves the JAK-STAT signaling pathway, which not only serves as a convergent node for pruritic signals but also constitutes a key downstream hub in the immune dysregulation characteristic of cholangitis. Inhibition of this pathway is therefore hypothesized to alleviate pruritus and modulate aberrant immune responses. Case reports have suggested that upadacitinib, a selective JAK inhibitor, may improve biochemical parameters in refractory PBC and exhibit potential anti-fibrotic effects. To this end, investigators plan to conduct an exploratory clinical study to systematically evaluate the safety and efficacy of upadacitinib in patients with atopic dermatitis complicated by moderate-to-severe pruritus and refractory autoimmune-associated cholangitis.

Key Dates

First listed
Jul 1, 2026
Start date
Jun 1, 2026
Status verified
Jun 2026
Primary completion
Nov 30, 2027
Completion
May 31, 2028

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients with atopic dermatitis complicated by moderate-to-severe pruritus and refractory PBC/PSC

Primary Outcome Measure

Pruritus of atopic dermatitis [ Time Frame: At screening, week 12 and week 24 ]

Central Contacts

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