NCT04117932: PB-USTE

Efficacy and Safety of Ustekinumab in Bullous Pemphigoid

Completed Phase 2 Last updated 8 August 2023

What this trial tests

Phase 2 trial testing Ustekinumab in Bullous Pemphigoid in 18 participants. Completed in 22 June 2023.

Timeline

11 March 2020

Primary endpoint
22 December 2022

22 June 2023

Quick facts

Lead sponsor	CHU de Reims
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	11 March 2020
Primary completion	22 December 2022
Estimated completion	22 June 2023
Sites	1 location across France

Drugs / interventions tested

• Ustekinumab (ustekinumab) — full drug profile →

Conditions studied

• Bullous Pemphigoid — all drugs for Bullous Pemphigoid →

Sponsor

CHU de Reims — full company profile →

Who can join

Adults 18 to 90, any sex, with Bullous Pemphigoid. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pemphigus and Pemphigoid: From Disease Mechanisms to Druggable Pathways.
   Ellebrecht CT, Maseda D, Payne AS. · · 2022 · cited 38× · PMID 34756581 · DOI 10.1016/j.jid.2021.04.040
2. Advancements in Bullous Pemphigoid Treatment: A Comprehensive Pipeline Update.
   Karakioulaki M, Eyerich K, Patsatsi A. · · 2024 · cited 35× · PMID 38157140 · DOI 10.1007/s40257-023-00832-1
3. The cytokine milieu of bullous pemphigoid: Current and novel therapeutic targets.
   Maglie R, Solimani F, Didona D, Pipitò C, et al · · 2023 · cited 21× · PMID 36814775 · DOI 10.3389/fmed.2023.1128154
4. A blistering new era for bullous pemphigoid: A scoping review of current therapies, ongoing clinical trials, and future directions.
   Khalid SN, Khan ZA, Ali MH, Almas T, et al · · 2021 · cited 17× · PMID 34540212 · DOI 10.1016/j.amsu.2021.102799
5. Adaptive and innate immune pathogenesis of bullous pemphigoid: A review.
   Yan T, Zhang Z. · · 2023 · cited 12× · PMID 36993969 · DOI 10.3389/fimmu.2023.1144429
6. Bullous Pemphygoid and Novel Therapeutic Approaches.
   D'Agostino GM, Rizzetto G, Marani A, Marasca S, et al · · 2022 · cited 11× · PMID 36359364 · DOI 10.3390/biomedicines10112844
7. A Review of the Immunologic Pathways Involved in Bullous Pemphigoid and Novel Therapeutic Targets.
   Afarideh M, Borucki R, Werth VP. · · 2022 · cited 11× · PMID 35628982 · DOI 10.3390/jcm11102856
8. Emerging Biomarkers and Therapeutic Strategies for Refractory Bullous Pemphigoid.
   Zhou T, Peng B, Geng S. · · 2021 · cited 11× · PMID 34504496 · DOI 10.3389/fimmu.2021.718073