Sonelokimab (M1095)
Drugrandomized treatment; parallel-group
NCT Number: NCT05322473
This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 2
Clinical Site, Sofia, Bulgaria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
randomized treatment; parallel-group
randomized treatment; parallel-group
randomized treatment; parallel-group
Time frame: At Week 12
HiSCR75 was defined as at least a 75% reduction from baseline in abscess and inflammatory nodule (AN) count, with no increase from baseline in abscess or draining fistula count. A non-responder imputation (NRI) method was used for missing data.
Time frame: At Week 12
HiSCR50 was defined as at least a 50% reduction from baseline in abscess and AN count, with no increase from baseline in abscess or draining fistula count. An NRI method was used for missing data.
Time frame: Baseline and Week 12
The IHS4 is a validated tool to dynamically assess hidradenitis suppurativa (HS) severity. The IHS4 score was calculated as: number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A total score of ≤3 signified mild, score of 4 to 10 signified moderate, and score of ≥11 signified severe disease. A negative change from baseline indicated an improvement in HS severity.
Time frame: At Week 12
The DLQI is an instrument designed to assess the impact of the disease on a participant's dermatology-specific quality of life (QoL). The DLQI total score ranged from 0 to 30, with higher scores indicating greater health-related QoL impairment. A negative change from baseline indicated an improvement in health-related QoL. An NRI method was used for missing data.
Time frame: At Week 12
The PGA of Skin Pain NRS in the past 24 hours was used to assess pain "at its worst" due to HS in the last 24 hours and was completed by the participant using the electronic Diary device. NRS scores ranged from 0 to 10, with higher scores indicating greater skin pain. The weekly averages score was calculated based on the available daily scores from the 7 days on or prior to the nominal day of the visit. The average of the 7 days on or before the date of first dose of trial treatment was used as baseline. A PGA skin pain responder was a participant who achieved NRS30, defined as at least 30% reduction and at least 1-unit reduction from baseline in NRS in PGA skin pain. An NRI method was used for missing data.
Looking for future studies?
Notify MeMoonLake Immunotherapeutics AG
Industry
Phase 2, Randomized, Parallel-group, Double-blind, Placebo-controlled Study of Sonelokimab in Patients With Active Moderate to Severe Hidradenitis Suppurativa
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06411899
Bacterial Infections, Bacterial Infections and Mycoses
Los Angeles, California, United States
View Trial DetailsNCT06411379
Bacterial Infections, Bacterial Infections and Mycoses
Birmingham, Alabama, United States
View Trial DetailsNCT07007637
Bacterial Infections, Bacterial Infections and Mycoses
Birmingham, Alabama, United States
View Trial DetailsNCT06768671
Bacterial Infections, Bacterial Infections and Mycoses
North Little Rock, Arkansas, United States
View Trial Details