An investigation of the efficacy and safety of low-dose IL-2 combined with low-dose hormone in the treatment of pemphigus and pemphigoid

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500099202

Enrollment

Unknown

Registered

2025-03-19

Start date

2023-08-01

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pemphigus

Interventions

experimental group:Low-dose interleukin 2 combined with low-dose hormones

control group:Starting hormone approximately 1mg/kg

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Voluntarily sign the informed consent form and be able to fully understand and comply with the trial-related processes; 2.Criteria for definitive diagnosis of the disease: diagnosis based on typical clinical presentation, histological type of lesion and direct immunofluorescence; 3.Age >= 18 years; 4.Patients with either primary or recurrent disease were eligible for enrolment; 5.For patients with moderate to severe pemphigus and pemphigoid, patients with pemphigus were selected with PDAI scores between 30 and 50; patients with pemphigoid were selected with BPDAI scores between 30 and 50.

Exclusion criteria

Exclusion criteria: 1.Those suffering from hyperthermia, severe hypotension, and patients with severe cardiac and renal insufficiency need to be excluded; 2.Recombinant human interleukin-2 has a history of toxicity associated with: sustained ventricular tachycardia; uncontrolled tachyarrhythmias; chest pain with electrocardiographic changes, angina pectoris, or myocardial infarction; cardiac tamponade; renal failure requiring dialysis for >72 hours; coma or toxic psychosis for >48 hours; intractable or refractory epilepsy; localised intestinal ischemia or perforation; and gastrointestinal haemorrhage requiring surgical intervention; 3.Exclude pregnancy or breastfeeding; 4.Patients with hypersensitivity to interleukin-2; 5.Exclude a history of other biologic use.

Design outcomes

Primary

Measure	Time frame
time to disease control;	—

Secondary

Measure	Time frame
Cumulative hormone dosage/body weight;The end of the consolidation period;The dose of steroids used when disease control is reached;	—

Countries

China

Contacts

Public ContactCao Xianwei

The First Affiliated Hospital of Nanchang University

ndyfyygk@163.com+86 13870891199

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026