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

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ClinicalTrials.gov Identifier: NCT04117932
Recruitment Status : Not yet recruiting
First Posted : October 7, 2019
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

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.


Condition or disease Intervention/treatment Phase
Bullous Pemphigoid Drug: Ustekinumab Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Ustekinumab in Bullous Pemphigoid
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pemphigus
Drug Information available for: Ustekinumab

Arm Intervention/treatment
Experimental: Arm "ustekinumab"
Patients with bullous pemphigoid, treated using ustekinumab in association during 8 weeks with superpotent topical corticosteroids
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).




Primary Outcome Measures :
  1. complete remission [ Time Frame: 28 weeks ]
    Complete remission is defined as the absence of new or established lesions (bullae, eczematous lesions or urticarial lesions)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04117932


Contacts
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Contact: Manuelle VIGUIER 03 10 73 66 76 mviguier@chu-reims.fr

Locations
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France
Damien JOLLY Not yet recruiting
Reims, France
Contact: Manuelle VIGUIER    03 10 73 66 76 ext 0033    mviguier@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims

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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT04117932     History of Changes
Other Study ID Numbers: PO19083
First Posted: October 7, 2019    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CHU de Reims:
bullous pemphigoid
ustekinumab
superpotent topical corticosteroids
efficacy
safety
Additional relevant MeSH terms:
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Pemphigoid, Bullous
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Ustekinumab
Dermatologic Agents