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A Seamless Phase 2a/2b, Randomized, Double-Blind, Placebo- and Active-Controlled, Multiple-Arm, Multiple-Stage, Adaptive Study Evaluating the Efficacy and Safety of LAD191 in Adults With Moderate-to-Severe Hidradenitis Suppurativa

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521293-34-00
Acronym
M-27134-10
Enrollment
128
Registered
2025-11-03
Start date
2025-12-09
Completion date
Unknown
Last updated
2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate-to-severe hidradenitis suppurativa

Brief summary

Proportion of participants achieving HiSCR 50, Safety endpoint: Frequency and severity of treatment-emergent AEs, SAEs, AEs leading to discontinuation, and AESIs, Safety endpoint: Local tolerance, vital signs, ECGs, and clinical laboratory parameters

Interventions

DRUGADALIMUMAB
DRUGLAD191 placebo
DRUGLAD191
DRUGSODIUM CHLORIDE

Sponsors

Almirall S.A.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Proportion of participants achieving HiSCR 50, Safety endpoint: Frequency and severity of treatment-emergent AEs, SAEs, AEs leading to discontinuation, and AESIs, Safety endpoint: Local tolerance, vital signs, ECGs, and clinical laboratory parameters

Countries

France, Germany, Ireland, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026