臨床研究等提出・公開システム

Lunsayil LTE: An extension trial assessing long-term spesolimab treatment in patients with Hidradenitis Suppurativa (HS)

A study to test long-term treatment with spesolimab in people with a skin condition disease called hidradenitis suppurativa (HS) who took part in a previous study with spesolimab

39

This trial included participants with HS who had completed their treatment in 1368-0098 part1. Of the 39 enrolled participants, 23 were male and 16 were female. The participants were aged 24 to 66 years, with a mean age of 41 years. The racial distribution was 51% White, 39% Asian, 5% Black or African American, and 5% unknown.

Of the 46 subjects enrolled (screened), 39 were treated with the median duration of drug exposure being 6.4 weeks (maximum being 23 weeks) due to early termination of trial.

Of the 39 patients treated, a total of 14 (35.9%) patients experienced an AE during the on-treatment period. The most frequently reported AE by SOC was infections and infestations, of which the most frequently reported PT was nasopharyngitis. Two (5.1%) patients were reported with AEs with CTCAE grade >=3 under PT hidradenitis. Three (7.7%) patients were reported with drug-related AEs assessed by investigator. The SOCs reported were general disorders (PT: Gastroenteritis, 1 patient, 6.2%) and administration site conditions (PT: injection site bruising (1 patient, 6.2%) and injection site pain (1 patient, 6.2%)). Two patients (5.1%) were reported with AESIs, namely interferon gamma release assay positive and Mycobacterium tuberculosis complex test positive. No AEs leading to treatment discontinuation were reported. No AEs leading to death were reported. Only one (2.6%) patient had SAEs (PT: sweat gland infection) under criteria required or prolonged hospitalisation.

The primary endpoint was the occurrence of treatment-emergent adverse events (TEAE) up to the end of the maintenance treatment period, including residual effect period (REP) (i.e. 16 weeks after the last trial treatment). There were no secondary endpoints defined in this trial. Efficacy was not analyzed in this report as this trial was terminated.

This was a randomised, double-blind, 92-week extension trial in participants with HS who had completed their treatment in trial 1368-0098 part 1. Given the early termination of this trial, no analysis or conclusions about the efficacy of spesolimab can be made. Of the 46 subjects enrolled (screened), 39 were treated. Overall, the safety and tolerability assessments of spesolimab did not yield any new safety concerns and were in line with the known safety profile of spesolimab.

https://clinicaltrials.gov/study/NCT06241573

Yes

Researchers can refer to https://trials.boehringer-ingelheim.com/ to request access to raw data from our clinical studies.

https://jrct.mhlw.go.jp/latest-detail/jRCT2031240075

Arita Takafumi

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

medchiken.jp@boehringer-ingelheim.com

Yamada Nobuko

Boehringer Ingelheim

2-1-1, Osaki, Shinagawa-ku, Tokyo

+81-120-189-779

medchiken.jp@boehringer-ingelheim.com

Complete

July. 04, 2024

Interventional

non-randomized controlled trial

double blind

dose comparison control

parallel assignment

treatment purpose

1. Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
2. Participants must be within the defined Residual Effect Period corresponding to 16 weeks since last spesolimab administration.
3. Participants who have completed treatment in the parent HS spesolimab trial without premature discontinuation and are willing and able to continue treatment in this trial. etc.

1. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
2. Use of any drug considered by the investigator likely to interfere with the safe conduct of the trial since the last visit of the parent trials.
3. Participants who require/ intend to use certain restricted medications such as immunomodulatory biologics or other investigational drugs/devices during the course of the trial. etc.

Both

Hidradenitis suppurativa

Drug: Spesolimab (Spevigo) / Solution for injection

D017497

The primary endpoint is the occurrence of treatment emergent adverse events (TEAE) up to the end of maintenance treatment period including REP (i.e., 16 weeks after the last study treatment).

Not applicable.

+81-3-3815-5411

April. 22, 2024

Argentina/Australia/Austria/Belgium/Bulgaria/Canada/Chile/China/Czech Republic/Denmark/Finland/France/Germany/Greece/Israel/Italy/Lithuania/Malaysia/Mexico/Netherlands/New Zealand/Norway/Philippines/Poland/Portugal/Singapore/Slovakia/South Africa/South Korea/Spain