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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Ustekinumab in Bullous Pemphigoid|
|Actual Study Start Date :||March 11, 2020|
|Estimated Primary Completion Date :||October 11, 2021|
|Estimated Study Completion Date :||April 11, 2022|
Experimental: Arm "ustekinumab"
Patients with bullous pemphigoid, treated using ustekinumab in association during 8 weeks with superpotent topical corticosteroids
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).
- complete remission [ Time Frame: 28 weeks ]Complete remission is defined as the absence of new or established lesions (bullae, eczematous lesions or urticarial lesions)
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
|Contact: Manuelle VIGUIER||03 10 73 66 email@example.com|
|Contact: Manuelle VIGUIER 03 10 73 66 76 ext 0033 firstname.lastname@example.org|