Brief Summary
This is a study to evaluate the long-term safety, tolerability, and efficacy of sonelokimab in participants with moderate to severe hidradenitis suppurativa who were previously enrolled in a parental study.
Brief Title
A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa
Completion Date
Completion Date Type
Estimated
Conditions
Hidradenitis Suppurativa
Eligibility Criteria
Inclusion Criteria:
* Participants who have completed a parental study (M1095-HS-301 or M1095-HS-302 \[adult studies\] or M1095-HS-304 \[adolescent study\]) and are eligible to continue to receive sonelokimab at the time of completing the parental study.
* Female participants are eligible to participate if they are not pregnant or breastfeeding
* Male participants must be willing to use a condom when sexually active with a partner of childbearing potential . Male participants must also agree to refrain from donating sperm during the study and for at least 8 weeks after the last dose of study treatment.
Exclusion Criteria:
* Participants who meet any of the discontinuation criteria of the parental study at the time of enrollment in this OLE study.
* Participants who have ongoing or planned to use one or more of the prohibited HS or non-HS treatments specified in the protocol.
* Participants who plan to participate in another interventional study for a drug or device during this study.
* Participants who have completed a parental study (M1095-HS-301 or M1095-HS-302 \[adult studies\] or M1095-HS-304 \[adolescent study\]) and are eligible to continue to receive sonelokimab at the time of completing the parental study.
* Female participants are eligible to participate if they are not pregnant or breastfeeding
* Male participants must be willing to use a condom when sexually active with a partner of childbearing potential . Male participants must also agree to refrain from donating sperm during the study and for at least 8 weeks after the last dose of study treatment.
Exclusion Criteria:
* Participants who meet any of the discontinuation criteria of the parental study at the time of enrollment in this OLE study.
* Participants who have ongoing or planned to use one or more of the prohibited HS or non-HS treatments specified in the protocol.
* Participants who plan to participate in another interventional study for a drug or device during this study.
Inclusion Criteria
Inclusion Criteria:
* Participants who have completed a parental study (M1095-HS-301 or M1095-HS-302 \[adult studies\] or M1095-HS-304 \[adolescent study\]) and are eligible to continue to receive sonelokimab at the time of completing the parental study.
* Female participants are eligible to participate if they are not pregnant or breastfeeding
* Male participants must be willing to use a condom when sexually active with a partner of childbearing potential . Male participants must also agree to refrain from donating sperm during the study and for at least 8 weeks after the last dose of study treatment.
* Participants who have completed a parental study (M1095-HS-301 or M1095-HS-302 \[adult studies\] or M1095-HS-304 \[adolescent study\]) and are eligible to continue to receive sonelokimab at the time of completing the parental study.
* Female participants are eligible to participate if they are not pregnant or breastfeeding
* Male participants must be willing to use a condom when sexually active with a partner of childbearing potential . Male participants must also agree to refrain from donating sperm during the study and for at least 8 weeks after the last dose of study treatment.
Gender
All
Gender Based
false
Keywords
Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Suppuration
Anti-Inflammatory Agents
Sonelokimab
Nanobody
Apocrine Gland Disease
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
12 Years
NCT Id
NCT07007637
Org Class
Industry
Org Full Name
MoonLake Immunotherapeutics AG
Org Study Id
M1095-HS-303
Overall Status
Enrolling by invitation
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Phase 3, Multicenter, Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa
Primary Outcomes
Outcome Description
Incidence, relatedness, severity and seriousness of all AEs
Outcome Measure
Long-term safety and tolerability of sonelokimab: Adverse events (AEs) following treatment with sonelokimab
Outcome Time Frame
2.5-3 years
Outcome Description
Incidence, relatedness, severity and seriousness of all TEAEs
Outcome Measure
Long-term safety and tolerability of sonelokimab: Treatment emergent adverse events (TEAEs)
Outcome Time Frame
2.5-3 years
Outcome Description
Incidence, relatedness, severity and seriousness of all AESIs
Outcome Measure
Long-term safety and tolerability of sonelokimab: Adverse events of special interest (AESIs)
Outcome Time Frame
2.5-3 years
Outcome Description
Number of participants discontinued from sonelokimab treatment due to AEs
Outcome Measure
Long-term safety and tolerability of sonelokimab: Discontinuation of sonelokimab treatment due to AEs
Outcome Time Frame
2.5-3 years
Outcome Description
Number of participants with clinically significant changes in hematology, biochemistry and urinalysis from baseline
Outcome Measure
Long-term safety and tolerability of sonelokimab: Clinically significant changes in clinical laboratory parameters
Outcome Time Frame
2.5-3 years
Outcome Description
Number of participants with clinically significant changes in vital signs and 12-lead ECG intervals from baseline
Outcome Measure
Long-term safety and tolerability of sonelokimab: Clinically significant changes in vital signs and standard 12-lead electrocardiogram
Outcome Time Frame
2.5-3 years
Secondary Ids
Secondary Id
VELA-OLE
Secondary Outcomes
Outcome Description
Percentage of participants achieving a HiSCR75 response over time
Outcome Time Frame
2.5 - 3 years
Outcome Measure
Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
Outcome Description
Percentage of participants achieving a HiSCR90 and HiSCAR50 response over time
Outcome Time Frame
2.5 - 3 years
Outcome Measure
Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Clinical Response 90 (HiSCR90) and 50 (HiSCR50)
Outcome Description
Absolute change in IHS4 score over time
Outcome Time Frame
2.5 - 3 years
Outcome Measure
Long-term efficacy of sonelokimab: International Hidradenitis Suppurativa Severity Score System (IHS4)
Outcome Description
Absolute change in number of abscesses, draining fistulas/tunnels; inflammatory nodules
Outcome Time Frame
2.5 - 3 years
Outcome Measure
Long-term efficacy of sonelokimab: Number of abscesses, draining fistulas/tunnels; inflammatory nodules
Outcome Description
Change in DLQI total score
Outcome Time Frame
2.5 - 3 years
Outcome Measure
Long-term efficacy of sonelokimab: Dermatology Life Quality Index (DLQI)
Outcome Description
Change in HiSQOL total score
Outcome Time Frame
2.5 - 3 years
Outcome Measure
Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Quality of Life (HiSQOL)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
12
Investigators
Investigator Type
Principal Investigator
Investigator Name
Holly Kanavy
Investigator Email
HKanavy@montefiore.org
Investigator Phone
866-633-8255 / 718-230-2997 / 510-996-0741
Investigator Department
Medicine
Investigator Division
Dermatology
Investigator Sponsor Organization
External
Study Department
Medicine
Study Division
Dermatology
Categories Mesh Debug
COVID-19 --- INFECTIONS
Infectious Disease --- INFECTIONS
Diabetes & Endocrine System --- INFLAMMATION
MeSH Terms
HIDRADENITIS SUPPURATIVA
HIDRADENITIS
SWEAT GLAND DISEASES
SKIN DISEASES
SKIN DISEASES, BACTERIAL
SUPPURATION
BACTERIAL INFECTIONS
BACTERIAL INFECTIONS AND MYCOSES
INFECTIONS
SKIN DISEASES, INFECTIOUS
SKIN AND CONNECTIVE TISSUE DISEASES
INFLAMMATION
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
SONELOKIMAB