Hidradenitis Suppurativa
Conditions
Keywords
Hidradenitis Suppurativa, Hidradenitis, Sweat Gland Diseases, Skin Diseases, Skin Diseases, Bacterial, Suppuration, Adalimumab, Anti-Inflammatory Agents, Sonelokimab, Nanobody, Folliculitis, Apocrine Gland Disease, Acne Inversa
Brief summary
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.
Interventions
DRUGSonelokimab (M1095)
randomized treatment; parallel-group
DRUGAdalimumab
randomized treatment; parallel-group
OTHERPlacebo
randomized treatment; parallel-group
Sponsors
MoonLake Immunotherapeutics AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participant is ≥18 years of age; 2. Participant has been diagnosed with hidradenitis suppurativa as determined by the investigator and has a history of signs and symptoms of hidradenitis suppurativa dating back at least 6 months prior to the Screening Visit; 3. Participant has a total abscess and/or inflammatory nodule (AN) count of ≥5; 4. Participant has hidradenitis suppurativa lesions present in ≥2 distinct anatomical areas, at least one of which must contain single or multiple fistulas (i.e., be Hurley Stage II or III); 5. Participant had an inadequate response to appropriate systemic antibiotics for treatment of hidradenitis suppurativa (or demonstrated intolerance to, or had a contraindication to, systemic antibiotics for treatment of their HS), in the investigator's opinion; 6. Participant must be, in the opinion of the investigator, at both the Screening Visit and study treatment initiation, a suitable candidate for treatment with adalimumab per approved local product information.
Exclusion criteria
1. Participants with known hypersensitivity to sonelokimab or any of its excipients; 2. Participants with known hypersensitivity to adalimumab or any of its excipients; 3. Participant has a draining fistula count of ≥20 at the Screening Visit; 4. Participant has any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of hidradenitis suppurativa; 5. Prior exposure to more than 2 biologic response modifiers; 6. Participant has a diagnosis of ulcerative colitis or Crohn's disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75 at Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving HiSCR50 at Week 12 | 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. |
| Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 12 | 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. |
| Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of ≤5 at Week 12 | 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. |
| Percentage of Participants Achieving a Numerical Rating Scale (NRS) 30 in Patient's Global Assessment (PGA) of Skin Pain at Week 12, in Participants With Baseline NRS ≥3 | 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. |
Countries
Bulgaria, Canada, Germany, Ireland, Netherlands, Poland, United States
Contacts
STUDY_DIRECTORMD
MoonLake Immunotherapeutics AG
Participant flow
Recruitment details
Participants were enrolled in 7 countries in Europe and North America. The trial included a screening period of up to 4 weeks, a 12-week placebo-controlled treatment period (Part A), a 12-week active treatment period (Part B), and safety follow-up period of 4 weeks (with safety follow-up visit occurring 8 weeks \[± 7 days\] after the last dose of trial treatment).
Pre-assignment details
In Part A, participants were randomized (2:2:2:1) to receive either: sonelokimab 120 mg, sonelokimab 240 mg, matching placebo, or adalimumab. In Part B, participants initially randomized to sonelokimab 120 mg or 240 mg continued on the same treatment for the remainder of the study, participants initially randomized to placebo were re-randomized (1:1) to either sonelokimab 120 mg or 240 mg, and participants initially randomized to adalimumab were reallocated to treatment with sonelokimab 240 mg.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 37.6 years STANDARD_DEVIATION 11.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 63 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 16 Participants |
| Race/Ethnicity, Customized Not reported | 1 Participants |
| Race/Ethnicity, Customized White | 29 Participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 68 | 0 / 67 | 0 / 66 | 0 / 33 | 0 / 33 | 0 / 29 | 0 / 62 | 0 / 64 | 0 / 32 |
| other Total, other adverse events | 29 / 68 | 39 / 67 | 36 / 66 | 21 / 33 | 14 / 33 | 17 / 29 | 23 / 62 | 30 / 64 | 12 / 32 |
| serious Total, serious adverse events | 2 / 68 | 2 / 67 | 1 / 66 | 0 / 33 | 0 / 33 | 0 / 29 | 0 / 62 | 0 / 64 | 1 / 32 |
Outcome results
None listed