Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Ustekinumab in Bullous Pemphigoid (PB-USTE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04117932
Recruitment Status : Recruiting
First Posted : October 7, 2019
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Tracking Information
First Submitted Date  ICMJE October 4, 2019
First Posted Date  ICMJE October 7, 2019
Last Update Posted Date March 18, 2020
Actual Study Start Date  ICMJE March 11, 2020
Estimated Primary Completion Date October 11, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2019)
complete remission [ Time Frame: 28 weeks ]
Complete remission is defined as the absence of new or established lesions (bullae, eczematous lesions or urticarial lesions)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Ustekinumab in Bullous Pemphigoid
Official Title  ICMJE Efficacy and Safety of Ustekinumab in Bullous Pemphigoid
Brief Summary

Bullous pemphigoid (BP) is an autoimmune subepidermal blistering disease and typically affects the elderly. Clinically, BP is an intensely pruritic erythematous eruption with widespread blister formation. BP is usually a chronic disease, with spontaneous exacerbations and remissions, which may be accompanied by significant morbidity.

BP usually requires on average a 1-year duration of treatment. Superpotent topical corticosteroids have been demonstrated to be effective. Despite their high efficacy, topical corticosteroids are often considered as poorly convenient, requiring the assistance of patients' relatives or a nurse to apply the topical treatment on a long period of time.

Overall, whereas BP lesions can be adequately and rapidly controlled with either topical corticosteroids, there is a high need for a safe maintenance therapy to avoid treatment side effects due to cumulative doses of corticosteroids over months.

Newer therapeutic agents such as ustekinumab targeting molecules involved in the inflammatory cascade associated with BP represent future alternatives to classical immunosuppressant drugs for maintenance therapy.

Detailed Description The aim of the study is to evaluate efficacy of ustekinumab in association during 8 weeks with superpotent topical corticosteroids in patients with bullous pemphigoid
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bullous Pemphigoid
Intervention  ICMJE Drug: Ustekinumab
Ustekinumab (90 mg subcutaneously at weeks 0, 4, 16), in association with topical superpotent corticosteroid (10-30 g per day during the first 4 weeks, then every other day during 4 weeks).
Study Arms  ICMJE Experimental: Arm "ustekinumab"
Patients with bullous pemphigoid, treated using ustekinumab in association during 8 weeks with superpotent topical corticosteroids
Intervention: Drug: Ustekinumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 4, 2019)
18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 11, 2022
Estimated Primary Completion Date October 11, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

inclusion criteria :

  • patient with bullous pemphigoid
  • patient aged between 18 and 90
  • patient with Karnofsky Performance score > 60%
  • patient agreed to participate to the study

exclusion criteria :

  • patient with allergy to corticosteroids
  • patient with allergy to ustekinumab
  • patient with any severe medical condition at time of inclusion including stroke, heart failure, renal failure, high blood pressure and diabetes mellitus
  • malignancy < 5 years prior to inclusion
  • pregnant or nursing (lactating) women, or women of child-bearing potential
  • active infection or with recent history of clinically significant infection within 4 weeks prior to inclusion
  • history or presence of infection with hepatitis B or C.
  • history or presence of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Manuelle VIGUIER 03 10 73 66 76 mviguier@chu-reims.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04117932
Other Study ID Numbers  ICMJE PO19083
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CHU de Reims
Study Sponsor  ICMJE CHU de Reims
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CHU de Reims
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP