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.
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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: Week 12
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75), where HiSCR75 is 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.
Time frame: Week 12
Proportion of participants achieving HiSCR50
Time frame: Week 12
Change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4)
The IHS4 score is calculated as follows: 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 or less signifies mild, 4 to 10 signifies moderate and 11 or higher signifies severe disease.
Time frame: Week 12
Proportion of participants achieving a Dermatology Life Quality Index (DLQI) total score of ≤5
The DLQI produces a numeric score that can range from 0 to 30. A higher score indicates greater health-related quality of life impairment.
Time frame: Week 12
Proportion of participants achieving at least 30% reduction and at least 2-unit reduction from Baseline in Numerical Rating Scale (NRS30) in Patient's Global Assessment of Skin Pain (PGA Skin Pain) among subjects with Baseline NRS ≥3
The NRS is a numeric scale in which the respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine).
MoonLake 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.
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