drugset / Trial / NCT02643654
MABp1 IN HIDRADENITIS SUPPURATIVA REFRACTORY TO ADALIMUMAB
Phase 2
Completed
20 enrolled
Evangelos J. Giamarellos-Bourboulis, M.D.
Hellenic Institute for the Study of Sepsis · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Hidradenitis suppurativa (HS) is a chronic inflammatory skin disorder. Although adalimumab is recently licensed for moderate to severe HS, many cases fail to respond or relapse during treatment. Favorable outcomes from a recently conducted double-blind randomized clinical study on the efficacy of anakinra, one interleukin(IL)-1alpha blocker, in hidradenitis suppurativa (HS), led to validate the efficacy of MABp1, a true human antiIL-1α antibody in these cases.
Timeline
- Start
- 2015-12
- Primary completion
- 2016-10
- Completion
- 2017-02
Publications
- Background Tzanetakou V, Kanni T, Giatrakou S, Katoulis A, Papadavid E, Netea MG, Dinarello CA, van der Meer JWM, Rigopoulos D, Giamarellos-Bourboulis EJ. Safety and Efficacy of Anakinra in Severe Hidradenitis Suppurativa: A Randomized Clinical Trial. JAMA Dermatol. 2016 Jan;152(1):52-59. doi: 10.1001/jamadermatol.2015.3903.
- Background Kimball AB, Jemec GB, Yang M, Kageleiry A, Signorovitch JE, Okun MM, Gu Y, Wang K, Mulani P, Sundaram M. Assessing the validity, responsiveness and meaningfulness of the Hidradenitis Suppurativa Clinical Response (HiSCR) as the clinical endpoint for hidradenitis suppurativa treatment. Br J Dermatol. 2014 Dec;171(6):1434-42. doi: 10.1111/bjd.13270. Epub 2014 Nov 11.
- Background Kanni T, Tzanetakou V, Savva A, Kersten B, Pistiki A, van de Veerdonk FL, Netea MG, van der Meer JW, Giamarellos-Bourboulis EJ. Compartmentalized Cytokine Responses in Hidradenitis Suppurativa. PLoS One. 2015 Jun 19;10(6):e0130522. doi: 10.1371/journal.pone.0130522. eCollection 2015.
- Background Kelekis NL, Efstathopoulos E, Balanika A, Spyridopoulos TN, Pelekanou A, Kanni T, Savva A, Brountzos E, Giamarellos-Bourboulis EJ. Ultrasound aids in diagnosis and severity assessment of hidradenitis suppurativa. Br J Dermatol. 2010 Jun;162(6):1400-2. doi: 10.1111/j.1365-2133.2010.09710.x. Epub 2010 Feb 22. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bermekimab | Monoclonal antibody | — | — |