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

NCT07678645 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-07-01

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Upadacitinib 15 MG

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.

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Xiong Ma, MD, PhD · RenJi Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-11-30
Completion
2028-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07678645 on ClinicalTrials.gov