search
Back to results

Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa

Primary Purpose

Hidradenitis Suppurativa

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Sonelokimab (M1095)
Adalimumab
Placebo
Sponsored by
MoonLake Immunotherapeutics AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring Hidradenitis Suppurativa, Hidradenitis, Sweat Gland Diseases, Skin Diseases, Skin Diseases, Bacterial, Suppuration, Adalimumab, Anti-Inflammatory Agents, Sonelokimab, Nanobody, Folliculitis, Apocrine Gland Disease, Acne Inversa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site
  • Clinical Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

sonelokimab dose 1

sonelokimab dose 2

Placebo

adalimumab

Arm Description

Subjects randomized to this arm will receive assigned sonelokimab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period.

Subjects randomized to this arm will receive assigned sonelokimab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period.

Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and will be re-randomized to receive a sonelokimab dosage regimen during Part B.

Subjects randomized to this arm will receive adalimumab during the Double-Blind Treatment Period and will be reallocated to receive sonelokimab dosage regimen during Part B.

Outcomes

Primary Outcome Measures

Hidradenitis Suppurativa Clinical Response 75
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.

Secondary Outcome Measures

Hidradenitis Suppurativa Clinical Response 50
Proportion of participants achieving HiSCR50
Change in International Hidradenitis Suppurativa Severity Score System
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.
Dermatology Life Quality Index (DLQI)
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.
Reduction from Numerical Rating Scale (NRS30) in Patient's Global Assessment of Skin Pain (PGA Skin Pain)
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).

Full Information

First Posted
April 4, 2022
Last Updated
October 2, 2023
Sponsor
MoonLake Immunotherapeutics AG
search

1. Study Identification

Unique Protocol Identification Number
NCT05322473
Brief Title
Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa
Official Title
Phase 2, Randomized, Parallel-group, Double-blind, Placebo-controlled Study of Sonelokimab in Patients With Active Moderate to Severe Hidradenitis Suppurativa
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 25, 2022 (Actual)
Primary Completion Date
May 9, 2023 (Actual)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MoonLake Immunotherapeutics AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
234 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sonelokimab dose 1
Arm Type
Experimental
Arm Description
Subjects randomized to this arm will receive assigned sonelokimab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period.
Arm Title
sonelokimab dose 2
Arm Type
Experimental
Arm Description
Subjects randomized to this arm will receive assigned sonelokimab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and will be re-randomized to receive a sonelokimab dosage regimen during Part B.
Arm Title
adalimumab
Arm Type
Active Comparator
Arm Description
Subjects randomized to this arm will receive adalimumab during the Double-Blind Treatment Period and will be reallocated to receive sonelokimab dosage regimen during Part B.
Intervention Type
Drug
Intervention Name(s)
Sonelokimab (M1095)
Intervention Description
randomized treatment; parallel-group
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Intervention Description
randomized treatment; parallel-group
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
randomized treatment; parallel-group
Primary Outcome Measure Information:
Title
Hidradenitis Suppurativa Clinical Response 75
Description
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
Secondary Outcome Measure Information:
Title
Hidradenitis Suppurativa Clinical Response 50
Description
Proportion of participants achieving HiSCR50
Time Frame
Week 12
Title
Change in International Hidradenitis Suppurativa Severity Score System
Description
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
Title
Dermatology Life Quality Index (DLQI)
Description
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
Title
Reduction from Numerical Rating Scale (NRS30) in Patient's Global Assessment of Skin Pain (PGA Skin Pain)
Description
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).
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant is ≥18 years of age; 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; Participant has a total abscess and/or inflammatory nodule (AN) count of ≥5; 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); 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; 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: Participants with known hypersensitivity to sonelokimab or any of its excipients; Participants with known hypersensitivity to adalimumab or any of its excipients; Participant has a draining fistula count of ≥20 at the Screening Visit; Participant has any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of hidradenitis suppurativa; Prior exposure to more than 2 biologic response modifiers; Participant has a diagnosis of ulcerative colitis or Crohn's disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Kristian Reich, M.D., Ph.D. (equ.)
Organizational Affiliation
MoonLake Immunotherapeutics AG
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Clinical Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90056
Country
United States
Facility Name
Clinical Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Clinical Site
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Clinical Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Clinical Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Clinical Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Clinical Site
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Facility Name
Clinical Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Clinical Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Clinical Site
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Clinical Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Clinical Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Clinical Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Clinical Site
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Clinical Site
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Clinical Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Clinical Site
City
Sofia
ZIP/Postal Code
1463
Country
Bulgaria
Facility Name
Clinical Site
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Clinical Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3E 0B2
Country
Canada
Facility Name
Clinical Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
Clinical Site
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 1G9
Country
Canada
Facility Name
Clinical Site
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 4Y3
Country
Canada
Facility Name
Clinical Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 3C3
Country
Canada
Facility Name
Clinical Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada
Facility Name
Clinical Site
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
Clinical Site
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
Country
Canada
Facility Name
Clinical Site
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
Clinical Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 2C1
Country
Canada
Facility Name
Clinical Site
City
Bad Bentheim
ZIP/Postal Code
48455
Country
Germany
Facility Name
Clinical Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Clinical Site
City
Berlin
ZIP/Postal Code
10789
Country
Germany
Facility Name
Clinical Site
City
Berlin
ZIP/Postal Code
13595
Country
Germany
Facility Name
Clinical Site
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Clinical Site
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
Facility Name
Clinical Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Clinical Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Clinical Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Clinical Site
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Clinical Site
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Clinical Site
City
Mahlow
ZIP/Postal Code
15831
Country
Germany
Facility Name
Clinical Site
City
München
ZIP/Postal Code
80337
Country
Germany
Facility Name
Clinical Site
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Clinical Site
City
Dublin
ZIP/Postal Code
D04 T6F4
Country
Ireland
Facility Name
Clinical Site
City
Bergen Op Zoom
ZIP/Postal Code
4624
Country
Netherlands
Facility Name
Clinical Site
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Clinical Site
City
Gdańsk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Clinical Site
City
Kraków
ZIP/Postal Code
31-033
Country
Poland
Facility Name
Clinical Site
City
Olsztyn
ZIP/Postal Code
10-341
Country
Poland
Facility Name
Clinical Site
City
Ossy
ZIP/Postal Code
42-624
Country
Poland
Facility Name
Clinical Site
City
Ostrowiec Świętokrzyski
ZIP/Postal Code
27-400
Country
Poland
Facility Name
Clinical Site
City
Poznań
ZIP/Postal Code
60-681
Country
Poland
Facility Name
Clinical Site
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Clinical Site
City
Warszawa
ZIP/Postal Code
02-692
Country
Poland
Facility Name
Clinical Site
City
Wrocław
ZIP/Postal Code
50566
Country
Poland
Facility Name
Clinical Site
City
Wrocław
ZIP/Postal Code
51318
Country
Poland
Facility Name
Clinical Site
City
Łódź
ZIP/Postal Code
90-265
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa

We'll reach out to this number within 24 hrs