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Randomized Controlled Trial
. 2024 Sep 18;191(4):508-518.
doi: 10.1093/bjd/ljae144.

Proof-of-concept study exploring the effect of spesolimab in patients with moderate-to-severe hidradenitis suppurativa: a randomized double-blind placebo-controlled clinical trial

Afsaneh Alavi  1 , Errol P Prens  2 , Alexa B Kimball  3 , John W Frew  4 , James G Krueger  5 , Sutirtha Mukhopadhyay  6 , Heli Gao  7 , Usha Ranganathan  6 , Nathalie B Ivanoff  6 , Ana C Hernandez Daly  6 , Christos C Zouboulis  8
Affiliations
Randomized Controlled Trial

Proof-of-concept study exploring the effect of spesolimab in patients with moderate-to-severe hidradenitis suppurativa: a randomized double-blind placebo-controlled clinical trial

Afsaneh Alavi et al. Br J Dermatol. .

Abstract

Background: Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease with a considerable disease burden. Existing treatment options are limited and often suboptimal; a high unmet need exists for effective targeted therapies.

Objectives: To explore the effects of spesolimab treatment in patients with HS.

Methods: This randomized double-blind placebo-controlled proof-of-clinical-concept (PoCC) study was conducted at 25 centres across 12 countries from 3 May 2021 to 21 April 2022. Patients had moderate-to-severe HS for ≥ 1 year before enrolment. Patients were randomized (2 : 1) to receive a loading dose of 3600-mg intravenous spesolimab (1200 mg at weeks 0, 1 and 2) or matching placebo, followed by maintenance with either 1200-mg subcutaneous spesolimab every 2 weeks from weeks 4 to 10 or matching placebo. The primary endpoint was the percentage change from baseline in total abscess and inflammatory nodule (AN) count at week 12. Secondary endpoints were the absolute change from baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4), percentage change from baseline in draining tunnel (dT) count, the proportion of patients achieving a dT count of 0, absolute change from baseline in the revised Hidradenitis Suppurativa Area and Severity Index (HASI-R), the proportion of patients achieving Hidradenitis Suppurativa Clinical Response (HiSCR50), the proportion of patients with ≥ 1 flare (all at week 12) and patient-reported outcomes.

Results: In this completed trial, randomized patients (n = 52) received spesolimab (n = 35) or placebo (n = 17). The difference vs. placebo in least squares mean is reported. At week 12, the percentage change in total AN count was similar between treatment arms: -4.1% [95% confidence interval (CI) -31.7 to 23.4]. There was greater numerical improvement in the spesolimab arm, as measured by IHS4 (13.9, 95% CI -25.6 to -2.3); percentage change from baseline in dT count (-96.6%, 95% CI -154.5 to -38.8); and the proportion of patients achieving a dT count of 0 (18.3%, 95% CI -7.9 to 37.5). Spesolimab treatment also improved HASI-R and HiSCR50 vs. placebo. Spesolimab demonstrated a favourable safety profile, similar to that observed in trials in other diseases.

Conclusions: This exploratory PoCC study supports the development of spesolimab as a new therapeutic option in HS.

Plain language summary

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease that affects approximately 0.4% to 1% of people worldwide. HS mainly affects areas where skin touches skin and can result in painful lumps and abscesses. Tunnel-shaped structures often form below the skin and discharge pus and can greatly affect a person’s quality of life. In this study, we tested a drug called ‘spesolimab’ as a treatment for people with moderate-to-severe HS. Spesolimab is a medicine in development that affects the immune system. This 12-week study included 52 adults who had moderate-to-severe HS for at least 1 year, from North America, Europe and Australia. People who took part were selected at random to receive either spesolimab or placebo. Thirty-five people received spesolimab and 17 received placebo into a vein once a week for 3 weeks, starting at week 0. They then received four injections of spesolimab or placebo under the skin once every 2 weeks until week 10. The number of lumps and abscesses, tunnels and a score based on their combination, called the International Hidradenitis Suppurativa Severity Score System (IHS4), were evaluated before spesolimab or placebo were given, and at week 12. We found that spesolimab and the placebo had a similar effect on the number of lumps and abscesses. However, more people treated with spesolimab showed improvements in tunnels and IHS4 score than those who received the placebo. The safety of spesolimab was favourable, similar to when spesolimab has been used in studies of other diseases. Our findings support further research into the use of spesolimab as a medicine for HS.

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Conflict of interest statement

Conflicts of interest A.A. is a consultant for AbbVie, Almirall, Boehringer Ingelheim, Incyte, InflaRx, Kymera, Novartis and UCB; and an investigator for Boehringer Ingelheim and Processa Pharmaceuticals. E.P. is a consultant and advisory board member for, and has received speaker fees from, AbbVie, Janssen, Novartis and UCB; and his institution has received grant support from AbbVie, Celgene, the Centre for Human Drug Research, Janssen, Novartis, Pfizer and UCB. A.B.K. declares receiving consultant fees from AbbVie, Alumis, Bayer, Boehringer Ingelheim, Eli Lilly, Janssen, MoonLake, Novartis, Pfizer, Priovant, Sanofi, Sonoma Bio, Target RWE and UCB; serves on the board of directors for Almirall; and her institution has received grant support from AbbVie, Admirx, AnaptysBio, Aristea, Bristol Myers Squibb, Eli Lilly, Incyte, Janssen, MoonLake, Novartis, Pfizer, Prometheus, Sonoma Bio and UCB. J.W.F. declares receiving research support from Ortho Dermatologics and Sun Pharmaceutical Industries; has conducted advisory work for AbbVie, Boehringer Ingelheim, Chemocentryx, Janssen, Kyowa Kirin, LEO Pharma, Pfizer, Regeneron and UCB; and has participated in clinical trials for Boehringer Ingelheim, CSL, Eli Lilly, Pfizer and UCB. J.G.K. declares receiving consultant fees/honoraria from AbbVie, Aclaris Therapeutics, Allergan, Almirall, Amgen, Arena, Aristea, Asana BioSciences, Aurigene, Bausch Health, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Escalier Biosciences, Galapagos, Janssen, MoonLake, Nimbus, Novartis, Pfizer, Sanofi, Sienna Biopharmaceuticals, Sun Pharmaceutical Industries, TARGET PharmaSolutions, UCB and Ventyx Biosciences; and his institution has received grant support from AbbVie, Akros, Allergan, Amgen, Avillion, Biogen, Botanix, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Exicure, Incyte, Innovaderm Research, Janssen, Kyowa Kirin, Nimbus Lakshmi, Novan, Novartis, Parexel, Pfizer, Regeneron, UCB and Vitae Pharmaceuticals. C.C.Z. declares receiving disease-relevant consultancy fees/honoraria from Boehringer Ingelheim, Eli Lilly, Idorsia, Incyte, Novartis, Pfizer, Sanofi, and UCB; has received speaker fees from Novartis, Pfizer and UCB; is President of the European Hidradenitis Suppurativa Foundation, Coordinator of the ALLOCATE skin group of European Reference Network Skin, and Chair of the Acne, Rosacea and Hidradenitis Suppurativa Task Force group of the European Academy of Dermatology and Venereology; is Editor of the European Academy of Dermatology and Venereology News and co-copyright holder of IHS4 on behalf of the European Hidradenitis Suppurativa Foundation; and his institution has received disease-relevant grants from Boehringer Ingelheim, InflaRx, Novartis and UCB. S.M., U.R., N.B.I. and A.C.H.D. are employees of Boehringer Ingelheim International GmbH; H.G. is an employee of Boehringer Ingelheim Shanghai Pharmaceuticals Co. Ltd.

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