Efficacy of Interleukin-2 Gargle in the Treatment of Oral Mucosa Lesion in Pemphigus Vulgaris

NCT04023149 | Unknown Phase 2

• 1 other identifier: IPOEMS201903
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study will test the short-term efficacy of interleukin-2 gargle combined with systemic use of glucocorticoids in the treatment of oral mucosal lesions in mucosal-dominant pemphigus vulgaris and moderate mucocutaneous pemphigus vulgaris.

Conditions

Pemphigus Vulgaris

Keywords

pemphigus vulgaris; oral mucosal lesion; interleukin-2

Outcome Measures

Primary Outcomes (1)

• The decline of the oral mucosa score of Pemphigus Disease Area Index (PDAI) after a 21-day treatment.

  (PDAI score on Day 0 - PDAI score on Day 21)/PDAI score on Day 0 × 100%

  from baseline to 21 days treatment

Secondary Outcomes (13)

• The decline of the oral mucosa score of Pemphigus Disease Area Index (PDAI) after a 7-, 14-, 28- and 42-day treatment, respectively.

  from baseline to 7, 14, 28 and 42 days, respectively

• The decline of Oral Disease Severity Score (ODSS) after a 7-, 14-, 21-, 28- and 42-day treatment, respectively.

  from baseline to 7, 14, 21, 28 and 42 days, respectively

• The decline of oral mucosa Visual Analogue Scale(VAS) after a 7-, 14-, 21-, 28- and 42-day treatment, respectively.

  from baseline to 7, 14, 21, 28 and 42 days, respectively

• The decline of Physician's Global Assessment (PGA) score for oral mucosa damage after a 7-, 14-, 21-, 28- and 42-day treatment, respectively.

  from baseline to 7, 14, 21, 28 and 42 days, respectively

• The decline of sera autoantibodies titer after a 21- and 42-day treatment, respectively.

  from baseline to 21 and 42 days, respectively

Study Arms (2)

experimental group

EXPERIMENTAL

Patients will receive rhIL-2 solution oral gargle twice per day (2 million units of rhIL-2 dissolved in 5ml normal saline for each dose, garble for 3 minutes) and continue for 3 weeks. A standard dose of glucocorticoids (mucosal-dominant PV: prednisone 0.5 mg/kg/d, moderate mucocutaneous PV: prednisone 0.75 mg/kg/d) will be applied at the same time.

Drug: recombinant human interleukin-2 (rhIL-2)

control group

PLACEBO COMPARATOR

Patients will receive placebo solution oral gargle twice per day (5ml for each dose, garble for 3 minutes) and continue for 3 weeks. A standard dose of glucocorticoids (mucosal-dominant PV: prednisone 0.5 mg/kg/d, moderate mucocutaneous PV: prednisone 0.75 mg/kg/d) will be applied at the same time.

Drug: placebo

Interventions

recombinant human interleukin-2 (rhIL-2) DRUG

Drug: rhIL-2; Pharmaceutical form: solution; Route of administration: oral gargle.

experimental group

placebo DRUG

Drug: placebo; Pharmaceutical form: solution; Route of administration: oral gargle.

control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: between 18 years and 70 years;
• Patients definitely diagnosed with pemphigus vulgaris according to 'Diagnostic Criteria for Pemphigus Vulgaris (Autoimmune Disease Sub-Professional Committee of Dermatologist Branch of Chinese Medical Doctor Association)'; or pemphigus vulgaris has been diagnosed in the past.
• Visible oral mucosa lesion due to pemphigus;
• Mucosal-dominant PV or moderate mucocutaneous PV (PDAI score: 15-45);
• Written informed consent was obtained, volunteer to participate in the project and complete as required.

You may not qualify if:

• Patients with severe diseases of heart, brain, lungs, liver, kidney or blood system; patients experienced organ transplantation;
• Patients with any acute severe infection such as pyemia and cellulitis, active tuberculosis, or an infection history of human immunodeficiency virus (HIV);
• Patients with allergic skin diseases with obvious pruritus such as eczema or urticaria, blood routine examination show elevated eosinophils or have a clear history of allergy to rhIL-2;
• Patients with persistent ventricular tachycardia, uncontrolled arrhythmias, chest pain with ECG changes, angina or myocardial infarction, cardiac tamponade;
• Patients with nausea, vomiting, peptic ulcer or intestinal ischemia;
• Patients with drug abuse, alcohol abuse, or mental disorders that are unable to cooperate or adhere to treatment;
• Pregnant women, lactating women or women who are ready to conceive within 3 months;
• Patients receiving treatment of immunosuppressants in the last 3 months;
• Patients receiving continuous treatment of glucocorticoids with a dose of more than 0.75 mg/kg/d in the last 2 weeks;
• Patients with oral fungal infection but don't receive antifungal therapy;
• Participated in other clinical trials within 3 months before the screening.

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

Study Sites (1)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

RECRUITING

MeSH Terms

Conditions

Pemphigus

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Qianjin Lu

  Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qianjin Lu, MD, PhD

CONTACT

+86-13787097676; qianlu5860@gmail.com

Hai Long

CONTACT

+86-18229743206; longhai021123@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director, Dept. of Dermatology, The Second Xiangya Hospital of Central South University

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 17, 2019
• Study Start: April 2, 2020
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)