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

Sponsor

MoonLake Immunotherapeutics AG (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05322473

Collaborator

(none)

210

Enrollment

Locations

Arms

18.2

Anticipated Duration (Months)

5.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hidradenitis Suppurativa	Drug: Sonelokimab (M1095) Drug: Adalimumab Other: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Phase 2, Randomized, Parallel-group, Double-blind, Placebo-controlled Study of Sonelokimab in Patients With Active Moderate to Severe Hidradenitis Suppurativa

Actual Study Start Date :

Apr 25, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: sonelokimab dose 1 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.	Drug: Sonelokimab (M1095) randomized treatment; parallel-group
Experimental: sonelokimab dose 2 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.	Drug: Sonelokimab (M1095) randomized treatment; parallel-group
Placebo Comparator: Placebo 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.	Other: Placebo randomized treatment; parallel-group
Active Comparator: adalimumab 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.	Drug: Adalimumab randomized treatment; parallel-group

Outcome Measures

Primary Outcome Measures

Hidradenitis Suppurativa Clinical Response 75 [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.

Secondary Outcome Measures

Hidradenitis Suppurativa Clinical Response 50 [Week 12]
Proportion of participants achieving HiSCR50
Change in International Hidradenitis Suppurativa Severity Score System [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.
Dermatology Life Quality Index (DLQI) [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.
Reduction from Numerical Rating Scale (NRS30) in Patient's Global Assessment of Skin Pain (PGA Skin Pain) [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Site	Fountain Valley	California	United States	92708
2	Clinical Site	Los Angeles	California	United States	90056
3	Clinical Site	Largo	Florida	United States	33770
4	Clinical Site	Miami	Florida	United States	33136
5	Clinical Site	Ormond Beach	Florida	United States	32127
6	Clinical Site	Tampa	Florida	United States	33613
7	Clinical Site	Indianapolis	Indiana	United States	46250
8	Clinical Site	Beverly	Massachusetts	United States	01915
9	Clinical Site	Boston	Massachusetts	United States	02215
10	Clinical Site	Saint Louis	Missouri	United States	63110
11	Clinical Site	Omaha	Nebraska	United States	68144
12	Clinical Site	New York	New York	United States	10003
13	Clinical Site	Durham	North Carolina	United States	27705
14	Clinical Site	Hershey	Pennsylvania	United States	17033
15	Clinical Site	Philadelphia	Pennsylvania	United States	19103
16	Clinical Site	Charleston	South Carolina	United States	29425
17	Clinical Site	Nashville	Tennessee	United States	37215
18	Clinical Site	Bellaire	Texas	United States	77401
19	Clinical Site	Sofia		Bulgaria	1407
20	Clinical Site	Sofia		Bulgaria	1431
21	Clinical Site	Sofia		Bulgaria	1463
22	Clinical Site	Stara Zagora		Bulgaria	6000
23	Clinical Site	Calgary	Alberta	Canada	T3E 0B2
24	Clinical Site	Winnipeg	Manitoba	Canada	R3M 3Z4
25	Clinical Site	Fredericton	New Brunswick	Canada	R3M 3Z4
26	Clinical Site	Saint John's	Newfoundland and Labrador	Canada	A1A 4Y3
27	Clinical Site	Burlington	Ontario	Canada	L7R 4H9
28	Clinical Site	London	Ontario	Canada	N6H 5L5
29	Clinical Site	Markham	Ontario	Canada	L3P 1X2
30	Clinical Site	Newmarket	Ontario	Canada	L3Y 5G8
31	Clinical Site	Peterborough	Ontario	Canada	K9J 5K2
32	Clinical Site	Saskatoon	Saskatchewan	Canada	S7K 2C1
33	Clinical Site	Gdańsk		Poland	80-214
34	Clinical Site	Kraków		Poland	31-033
35	Clinical Site	Ossy		Poland	42-624
36	Clinical Site	Poznań		Poland	60-369
37	Clinical Site	Warszawa		Poland	02-507
38	Clinical Site	Warszawa		Poland	02-692
39	Clinical Site	Wrocław		Poland	50566
40	Clinical Site	Łódź		Poland	90-436