Lunsayil 1: A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa
Public ClinicalTrials.gov record NCT05819398. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomised, Double-blind, Placebo-controlled, Phase IIb/Phase III Study to Evaluate the Efficacy and Safety of Spesolimab in Patients With Moderate to Severe Hidradenitis Suppurativa. Lunsayil 1.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is open to adults with moderate to severe hidradenitis suppurativa (HS). The purpose of this study is to find out whether a medicine called spesolimab helps people with HS. People who have previously taken specific medicines such as immunosuppressive biologics other than Tumor necrosis factor (TNF) inhibitors cannot take part. This study has 2 parts. In Part 1, participants are divided into 4 groups of almost equal size. 3 groups get different doses of spesolimab, 1 group gets placebo. All participants get injections into a vein or under the skin. Placebo injections look like spesolimab injections, but do not contain any medicine. Every participant has an equal chance of being in each group. In the beginning, participants get the study medicine every week and later every 2 weeks. After 4 months, participants in the placebo group switch to spesolimab treatment. In Part 2, participants are divided into 2 groups. One group gets a suitable dose of spesolimab that was found in Part 1 of the study. The other group gets placebo. After 4 months, participants in the placebo group switch to spesolimab treatment. Participants join only one of the two parts. They are in the study for about 1 year. During this time, they visit the study site in the beginning every week and later every 2 weeks. Some of the visits can be done at the participant's home instead of the study site. The doctors regularly check participants' HS symptoms. The results are compared between the groups to see whether spesolimab works. The doctors also regularly check participants' general health and take note of any unwanted effects.
Study identification
- NCT ID
- NCT05819398
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 209 participants
Conditions and interventions
Conditions
Interventions
- Spesolimab i.v. Drug
- Spesolimab s.c. Drug
- Placebo matching Spesolimab i.v. Drug
- Placebo matching Spesolimab s.c. Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 16, 2023
- Primary completion
- Jul 31, 2024
- Completion
- Mar 30, 2025
- Last update posted
- Nov 4, 2025
2023 – 2025
United States locations
- U.S. sites
- 19
- U.S. states
- 11
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| First OC Dermatology | Fountain Valley | California | 92708 | — |
| Dermatology Research Associates | Los Angeles | California | 90045 | — |
| Integrative Skin Science and Research-Sacramento-69402 | Sacramento | California | 95815 | — |
| Clinical Trials Research Institute | Thousand Oaks | California | 91320 | — |
| Ziaderm Research | North Miami Beach | Florida | 33162 | — |
| ForCare Clinical Research, Inc. | Tampa | Florida | 33613 | — |
| Olympian Clinical Research-Tampa-69560 | Tampa | Florida | 33615 | — |
| Dawes Fretzin Clinical Research Group, LLC-Indianapolis -68995 | Indianapolis | Indiana | 46250 | — |
| Skin Sciences, PLLC | Louisville | Kentucky | 40217 | — |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | — |
| Oakland Hills Dermatology, PC | Auburn Hills | Michigan | 48326 | — |
| Skin Specialists, P.C. | Omaha | Nebraska | 68144 | — |
| AXIS Clinicals | Fargo | North Dakota | 58103 | — |
| Unity Clinical Research | Oklahoma City | Oklahoma | 73118 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Palmetto Clinical Trial Services | Greenville | South Carolina | 29615 | — |
| Center for Clinical Studies-Houston-58806 | Houston | Texas | 77004 | — |
| Progressive Clinical Research | San Antonio | Texas | 78213 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 143 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05819398, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 4, 2025 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05819398 live on ClinicalTrials.gov.