Efficacy and Safety of Ustekinumab in Bullous Pemphigoid

NCT04117932 | Completed Phase 2

• 1 other identifier: PO19083
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Bullous Pemphigoid

Keywords

bullous pemphigoid; ustekinumab; superpotent topical corticosteroids; efficacy; safety

Outcome Measures

Primary Outcomes (1)

• complete remission

  Complete remission is defined as the absence of new or established lesions (bullae, eczematous lesions or urticarial lesions)

  28 weeks

Study Arms (1)

Arm "ustekinumab"

EXPERIMENTAL

Patients with bullous pemphigoid, treated using ustekinumab in association during 8 weeks with superpotent topical corticosteroids

Drug: Ustekinumab

Interventions

Ustekinumab DRUG

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).

Arm "ustekinumab"

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• patient with allergy to corticosteroids
• patient with allergy to ustekinumab
• pregnant or nursing (lactating) women, or women of child-bearing potential
• 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.

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

Location

MeSH Terms

Conditions

Pemphigoid, Bullous

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 7, 2019
• Study Start: March 11, 2020
• Primary Completion: December 22, 2022
• Study Completion: June 22, 2023
• Last Updated: August 8, 2023

Record last verified: 2022-03

Locations

FR (1)