Clinical Utility Of Genetic Screening For HLA-B*1301, On Susceptibility To Dapsone Hypersensitivity Syndrome

Psoriasis Clinical Trial

Official title:

A Phase IV, Randomised, Multicentre, Double-blind, Study to Evaluate the Clinical Utility of Prospective Genetic Screening (HLA-B*1301) for Susceptibility to Dapsone Hypersensitivity Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02550080
• Other study ID #: SDPIDV-DDS-001
• Status: Recruiting
• Phase: Phase 4
• First received: August 20, 2015
• Last updated: March 1, 2017
• Start date: July 2015
• Est. completion date: May 2019

Study information

• Verified date: March 2017
• Source: Shandong Provincial Institute of Dermatology and Venereology
• Contact: Yonghu Sun, PhD
• Phone: +86-531-87298870
• Email: hongyue2519[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This Study is to evaluate the utility of prospective HLA-B*1301 screening on the incidence of dapsone hypersensitivity syndrome (DHS) in 3130 previously Dapsone(DDS)-naive patients. Those patients include allergic cutaneous vasculitis, urticaria, psoriasis, acne, bullous skin diseases, sterile pustulosis, leprosy, pneumocystis pneumonia and any other patients who need dapsone administration. The study has two (co-primary) objectives: i) to determine if screening for HLA-B*1301 prior to DDS-containing treatment results in a lower incidence of clinically-suspected DHS versus current standard of care (no genetic screening) and ii) to determine if screening for HLA-B*1301 prior to DDS-containing treatment results in a significantly lower incidence of immunologically-confirmed DHS versus current standard of care (no genetic screening or patch testing). The study consists of up to a 5-day screening period, a randomised observation period (Day 1 through Week 6) and, for subjects experiencing a suspected DHS and a subset of DDS-tolerant subjects, an epicutaneous patch test (EPT) assessment period. Eligible subjects will be randomised to one of two study arms: a Current Standard of Care Arm (no prospective genetic screening: Control) and a Genetic Screening Arm (prospective genetic screening: Case). Subjects identified as HLA-B*1301 positive in the prospective Genetic Screening Arm will not receive dapsone and will be excluded from further study. Subjects who experience suspected DHS during the 6-week observation would be withdrawn from dapsone and undergo EPT patch testing 6 weeks later.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3130
• Est. completion date: May 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosed with cutaneous vasculitis, urticaria, psoriasis, acne, bullous skin diseases, sterile pustulosis, leprosy, pneumocystis pneumonia and any other patients who need dapsone administration.

• Subjects are dapsone-naive.

• All subjects must have a clinical need for treatment with dapsone that precedes the decision to participate in the study.

• All subjects are willing to complete the 6-weeks period clinical trial.

• All subjects are written informed consent.

Exclusion Criteria:

• Has previously received Dapsone therapy.

• The subject or any of their healthcare providers is aware of the subjects HLA type.

• Has been diagnosed with Glucose-6-phosphate dehydrogenase deficiency or methemoglobin reductase deficiency

• Satisfies any contraindications or restrictions to Dapsone therapy as listed in the product labels.

• Current severe illness, including heart, liver and renal failure, major organ allograft, malignancy requiring parenteral chemotherapy that can not be discontinued for the duration of the trial, or any other conditions which, in the opinion of the Investigator, would make the patient unsuitable for the study.

• Any laboratory abnormality at Screening which, in the opinion of the Investigator, should preclude the subject's participation in the study [alanine aminotransferase (ALT), glutamic oxaloacetic transaminase(ALT), et al).

• Pregnant women or women who are breastfeeding.

• Subject is, in the opinion of the Investigator, unable to complete the 6 week Observation period and the EPT assessments as required.

• A positive result for HLA-B*1301 in those subjects randomised to the genetic screening arm.

Related Conditions & MeSH terms

• Acne
• Allergic Cutaneous Vasculitis
• Bullous Skin Diseases
• Disease Susceptibility
• Drug Hypersensitivity Syndrome
• Hypersensitivity
• Leprosy
• Pneumocystis Pneumonia
• Pneumonia
• Pneumonia, Pneumocystis
• Psoriasis
• Skin Diseases
• Sterile Pustulosis
• Urticaria
• Vasculitis

Intervention

Drug:
• Dapsone
For the HLA-B*1301 positive subjects, dapsone will not be administrated.

Genetic:
• HLA-B*1301
The prospective genetic screening group will be tested before administrating dapsone

Locations

Country	Name	City	State
China	Shandong Provincial Institute of Dermatology and Venereology	Jinan	Shandong

Sponsors (16)

Lead Sponsor

Collaborator

Shandong Provincial Institute of Dermatology and Venereology

Dezhou People's Hospital,Shandong, Dongying People's Hospital,Shandong, Jinan Central Hospital, Jinan City Dermatology Hospital Prevention and Treatment, Jinan Military General Hospital, Jining City Dermatology Hospital Prevention and Treatment, Laiwu City Dermatology Hospital Prevention and Treatment, Liaocheng People's Hospital, Linyi City Dermatology Hospital Prevention and Treatment, Qingdao Center Medical Group, Rizhao City Dermatology Hospital Prevention and Treatment, Shandong Jining No. 1 People's Hospital, Shandong Provincial Hospital, Shandong Qianfo Hospital, Weifang City Dermatology Hospital Prevention and Treatment

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of clinically-suspected DHS during the 6-week observation period	The primary outcome measure will be the total number of clinically suspected Dapsone induced hypersensitivity syndrome during the 6-week observation period in both the prospective-screening group and control group, as reported by the DHS incidence (DHS patients/ total participants).	6 weeks
Primary	Incidence of immunologically-confirmed DHS during the 6-week observation period	The primary outcome measure will be the total number of immunologically confirmed Dapsone induced hypersensitivity syndrome during the 6-week observation period in both the prospective-screening group and control group, as reported by the DHS incidence (DHS patients/ total participants).	6 weeks