Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Backgrounds: Pemphigus vulgaris (PV) is a life-threatening autoimmune bullous skin disease characterized by blisters or bullae on the skin and mucosal membranes. The formation of painful erosion surface after rupture of blisters may result in infection, haemorrhage and even electrolyte imbalance due to excessive water loss. PV can be divided into two types: mucocutaneous PV and mucosal-dominant PV. Patients with mucocutaneous PV not only suffer from severe mucosal damage but also general skin lesions, while slight or no skin lesions involved in patients with mucosal-dominant PV. Oral mucosal damage occurred 3 months to 1 year before skin lesions in about 60% of PV patients. The most common involving parts of the oral mucosa are pars buccalis and oropharynx, presenting with persistent and painful erosion or ulceration, which leads to difficulty in feeding and aggravates the electrolyte imbalance. Glucocorticoid is the main treatment strategy of PV. Besides the blisters and erosion, complications of long-term use of glucocorticoid are also the death causes of PV patients, such as osteoporosis, hyperglycemia, hypertension, hypokalemia, femoral head necrosis, peptic ulcer, and infection. Many patients have gotten remission from the standard application of glucocorticoids, Immunosuppressants and biological agent. However, there is still a part of patients that are insensitive to these drugs or intolerant the side effects of corticosteroids. Even for those steroid-sensitive patients, the healing of oral mucosa often takes a long course, lasting from weeks to months, which has a serious impact on the quality of life. It is a critical problem to develop novel therapeutics to accelerate the healing of oral mucosa. Recombinant human interleukin-2 (rhIL-2) is an immunomodulator agent commonly used in the treatment of patients with tumours. The safety and efficacy of low dose rhIL-2 have been demonstrated in the treatment of type I diabetes, systemic lupus erythematosus, and graft-versus-host disease. We found that topical application of rhIL-2 can effectively relieve pain and improve the condition of oral mucosa for PV patients. Studies have shown that IL-2 selectively modulates CD4+ T cell subsets and increases the amounts and function of regulatory T cells. Moreover, IL-2 plays an important role in the proliferation of fibroblasts and wound healing. These evidences provide us the theoretical basis to explore the potential mechanism of rhIL-2 in treatment of mucosal damage of patients with PV. Design of Study: This is a randomized, controlled, double-blind, multicenter clinical trial to assess the safety and short-term efficacy of rhIL-2 for oral erosion in patients with pemphigus. Methods: rhIL-2 oral gargle combined with the standard dose of glucocorticoids (mucosal-dominant PV: prednisone 0.5 mg/kg/d, mucocutaneous PV: prednisone 1 mg/kg/d) will be applied to pemphigus patients meeting the inclusion criteria. The end points include clinical response and immunological changes, as well as safety. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04023149
Study type Interventional
Source Second Xiangya Hospital of Central South University
Contact Qianjin Lu, MD, PhD
Phone +86-13787097676
Email qianlu5860@gmail.com
Status Recruiting
Phase Phase 2
Start date April 2, 2020
Completion date December 1, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT04422912 - A Phase 1/2, Open-label, Safety and Dosing Study of Autologous CART Cells (Desmoglein 3 Chimeric Autoantibody Receptor T Cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T Cells [CABA-201]) in Subjects With Active, Pemphigus Vulgaris (RESET-PV) Phase 1
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Recruiting NCT04117529 - Phenotypic and Functional Characterisation of Human B-cell Response in Pemphigus N/A
Completed NCT03334058 - A Study to Evaluate the Safety, PD, PK and Efficacy of ARGX-113 in Patients With Pemphigus Phase 2
Terminated NCT03239470 - Polyclonal Regulatory T Cells (PolyTregs) for Pemphigus Phase 1
Completed NCT00606749 - Use of KC706 for the Treatment of Pemphigus Vulgaris Phase 2
Terminated NCT00429533 - Efficacy of Dapsone as a Steroid Sparing Agent in Pemphigus Vulgaris Phase 2
Recruiting NCT05594472 - Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid Phase 3
Completed NCT02383589 - A Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil (MMF) in Participants With Pemphigus Vulgaris (PV) Phase 3
Withdrawn NCT03780166 - A Study of the Safety and Tolerability of INCB050465 in Pemphigus Vulgaris Phase 2
Recruiting NCT04096222 - Comparative Analysis of the Th17 Cellular Response in Active and Inactive Pemphigus Vulgaris Patients
Not yet recruiting NCT03177213 - Serum IL-21 Levels in Patients With Pemphigus Vulgaris N/A
Completed NCT00135720 - Study of Etanercept (Enbrel) in the Treatment of Pemphigus Vulgaris Phase 2
Completed NCT00063752 - Safety Study of PI-0824 to Treat Pemphigus Vulgaris Phase 1
Terminated NCT03075904 - A Safety and Dose-Finding Study of SYNT001 in Subjects With Pemphigus (Vulgaris or Foliaceus) Phase 1/Phase 2
Terminated NCT04598477 - A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus) Phase 3
Completed NCT02704429 - A Study of PRN1008 in Adult Patients With Pemphigus Vulgaris Phase 2
Completed NCT00626678 - Azathioprine Versus Placebo in Pemphigus Vulgaris Treated With Prednisolone Phase 2
Active, not recruiting NCT05338112 - Role of Tzanck Smear in Determining Pemphigus Vulgaris Disease Activity
Completed NCT06167408 - Identifying Factors Influencing In-Hospital Relapse in Pemphigus Patients