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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2021
• Main ID: NCT04023149
• Date of registration: 03/07/2019
• Prospective Registration: Yes
• Primary sponsor: Second Xiangya Hospital of Central South University
• Public title: Efficacy of Interleukin-2 Gargle in the Treatment of Oral Mucosa Lesion in Pemphigus Vulgaris
• Scientific title: Short-term Efficacy of Interleukin-2 Gargle Combined With Systemic Use of Glucocorticoids in the Treatment of Oral Mucosal Lesion in Pemphigus Vulgaris: a Randomized, Controlled, Double-blind, Multicenter Clinical Study
• Date of first enrolment: April 2, 2020
• Target sample size: 180
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT04023149
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

China

Contacts

• Name: Qianjin Lu
• Affiliation: Central South University

• Name: Qianjin Lu, MD, PhD

• Name: Xiangqi Tang, MD, PhD

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age: between 18 years and 70 years;

2. 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.

3. Visible oral mucosa lesion due to pemphigus;

4. Mucosal-dominant PV or moderate mucocutaneous PV (PDAI score: 15-45);

5. Written informed consent was obtained, volunteer to participate in the project and
complete as required.

Exclusion Criteria:

1. Patients with severe diseases of heart, brain, lungs, liver, kidney or blood system;
patients experienced organ transplantation;

2. Patients with any acute severe infection such as pyemia and cellulitis, active
tuberculosis, or an infection history of human immunodeficiency virus (HIV);

3. 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;

4. Patients with persistent ventricular tachycardia, uncontrolled arrhythmias, chest pain
with ECG changes, angina or myocardial infarction, cardiac tamponade;

5. Patients with nausea, vomiting, peptic ulcer or intestinal ischemia;

6. Patients with drug abuse, alcohol abuse, or mental disorders that are unable to
cooperate or adhere to treatment;

7. Pregnant women, lactating women or women who are ready to conceive within 3 months;

8. Patients receiving treatment of immunosuppressants in the last 3 months;

9. Patients receiving continuous treatment of glucocorticoids with a dose of more than
0.75 mg/kg/d in the last 2 weeks;

10. Patients with oral fungal infection but don't receive antifungal therapy;

11. Participated in other clinical trials within 3 months before the screening.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pemphigus Vulgaris

Intervention(s)

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

Drug: placebo

Primary Outcome(s)

The decline of the oral mucosa score of Pemphigus Disease Area Index (PDAI) after a 21-day treatment. [Time Frame: from baseline to 21 days treatment]

Secondary Outcome(s)

The percentage of patients from whose oral mucosa the fungal infection can be detected on Day 21 and Day 42. [Time Frame: 21 and 42 days]

The change of serum potassium level on Day 21 and Day 42. [Time Frame: 21 and 42 days]

The change of white blood cell (WBC) counts on Day 21 and Day 42. [Time Frame: 21 and 42 days]

The decline of Oral Disease Severity Score (ODSS) after a 7-, 14-, 21-, 28- and 42-day treatment, respectively. [Time Frame: from baseline to 7, 14, 21, 28 and 42 days, respectively]

The decline of the oral mucosa score of Pemphigus Disease Area Index (PDAI) after a 7-, 14-, 28- and 42-day treatment, respectively. [Time Frame: from baseline to 7, 14, 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. [Time Frame: from baseline to 7, 14, 21, 28 and 42 days, respectively]

The percentage of patients receiving incremental dose of glucocorticoids, steroid pulse therapy, or combined with immunosuppressants/intravenous immunoglobulin(IVIG)/biological agents on Day 28 and Day 42, respectively. [Time Frame: 28 and 42 days]

The safety evaluation about the drug adverse reactions throughout the entire study process. [Time Frame: through study completion, an average of 42 days]

The change of serum albumin level on Day 21 and Day 42. [Time Frame: 21 and 42 days]

The decline of Physician's Global Assessment (PGA) score for oral mucosa damage after a 7-, 14-, 21-, 28- and 42-day treatment, respectively. [Time Frame: from baseline to 7, 14, 21, 28 and 42 days, respectively]

The change of fasting blood-glucose (FBS) level on Day 21 and Day 42. [Time Frame: 21 and 42 days]

The decline of sera autoantibodies titer after a 21- and 42-day treatment, respectively. [Time Frame: from baseline to 21 and 42 days, respectively]

The dose of glucocorticoids on Day 28 and Day 42, respectively. [Time Frame: 28 and 42 days]

Secondary ID(s)

IPOEMS201903

Source(s) of Monetary Support

Please refer to primary and secondary sponsors