Clinical Trials Register

Summary
EudraCT Number:	2021-005928-38
Sponsor's Protocol Code Number:	M1095-HS-201
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2022-04-11
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Netherlands - Competent Authority

A.2

EudraCT number

2021-005928-38

A.3

Full title of the trial

Phase 2, randomized, parallel-group, double-blind, placebo-controlled study of sonelokimab in patients with active moderate to severe hidradenitis suppurativa

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Evaluation of Sonelokimab for the treatment of patients with active moderate to severe HS

A.4.1

Sponsor's protocol code number

M1095-HS-201

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	MoonLake Immunotherapeutics AG
B.1.3.4	Country	Switzerland
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	MoonLake Immunotherapeutics AG
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	MoonLake Immunotherapeutics AG
B.5.2	Functional name of contact point	Clinical Trial Information
B.5.3	Address:
B.5.3.1	Street Address	Dorfstrasse 29
B.5.3.2	Town/ city	Zug
B.5.3.3	Post code	6300
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	+41415108022
B.5.6	E-mail	ClinicalTrials@moonlaketx.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Sonelokimab
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Sonelokimab
D.3.9.1	CAS number	1414386-05-2
D.3.9.4	EV Substance Code	SUB196986
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	120
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Humira®
D.2.1.1.2	Name of the Marketing Authorisation holder	AbbVie Deutschland GmbH Co. KG
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	adalimumab
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Adalimumab
D.3.9.1	CAS number	331731-18-1
D.3.9.4	EV Substance Code	SUB20016
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection in pre-filled syringe
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Active moderate to severe hidradenitis suppurativa

E.1.1.1

Medical condition in easily understood language

Pain due to a skin condition that causes small, painful lumps to form under the skin and scarring on the skin.

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10020041
E.1.2	Term	Hidradenitis suppurativa
E.1.2	System Organ Class	100000004858

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the efficacy of sonelokimab at 2 different dose levels (120 mg, 240 mg) compared with placebo in the treatment of participants with active moderate to severe hidradenitis suppurativa.

E.2.2

Secondary objectives of the trial

1. To evaluate the safety and tolerability of sonelokimab at 2 different dose levels (120 mg, 240 mg) compared with placebo in the treatment of participants with active moderate to severe hidradenitis suppurativa;
2. To assess the pharmacokinetics (PK) and immunogenicity of sonelokimab at 2 different dose levels (120 mg, 240 mg) in the treatment of participants with active moderate to severe hidradenitis suppurativa.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. ≥18 years of age.
2. Diagnosed with HS and has a history of signs and symptoms of HS dating back at least 6 months.
3. Total AN count (i.e., abscesses and/or inflammatory nodules) of ≥5.
4. Subject has HS 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. Subject had an inadequate response to appropriate systemic antibiotics for treatment of HS (or demonstrated intolerance to, or had a contraindication to, systemic antibiotics for treatment of their HS).
6. Participants must a suitable candidate for treatment with adalimumab per approved local product information. If a chest X-ray or computed tomography (CT) for tuberculosis (TB) screening is required per local guidance, the X-ray or CT must have been taken within 3 months prior to the Screening.
7. If the subject is female, must be of non-childbearing potential or if of childbearing potential, participant must agree to use highly effective methods of contraception.
8. Women of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) pregnancy test at screening and a negative urine pregnancy test at Week 0/Day1 prior to the first administration of study treatment.
9. If male, participant must be willing to use a condom when sexually active with a partner of childbearing potential during the study and for 12 weeks after the last dose of study drug, unless surgically sterile.
10. Participant is considered reliable and capable of adhering to the protocol, visit schedule, or medication intake according to the judgment of the investigator.
11. Participant is able to understand and provide signed informed consent.

E.4

Principal exclusion criteria

1. Known hypersensitivity to sonelokimab, adalimumab or any of its excipients.
2. Draining fistula count of ≥20.
3. Any other active skin disease or condition that may interfere with the assessment of HS.
4. Subject who currently use or plan used one or more prohibited treatments specified in this protocol.
5. Subjects enrolling in the non-antibiotic strata: use of systemic antibiotics for the treatment of HS within 28 days.
6. Previous exposure or subject in a study of brodalumab (anti-IL-17RA) and/or bimekizumab (anti-IL17 A/F).
7. Unsuitable for interleukin (IL)-17A therapy and anti-tumor necrosis factor alpha (TNFα) therapy.
8. Prior exposure to more than 2 biologic response modifiers.
9. Diagnosis of ulcerative colitis or Crohn’s disease.
10. Subject has an active infection or history of infections.
11. Participant with evidence of TB infection at screening unless the following criteria apply:
i. A full TB work-up within 12 weeks establishes no evidence of active or TB infection.
ii. Positive for latent TB per work-up must have completed sufficient treatment at least 4 weeks prior.
12. Any current nontuberculous mycobacterial (NTM) infection or any history of pulmonary NTM infection.
13. Concurrent acute or chronic viral hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
14. Evidence of human immunodeficiency virus (HIV) infection.
15. Tests positive for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection.
16. Concurrent malignancy or a history of malignancy during the past 5 years of with the following exceptions:
a. ≤3 successfully excised or ablated, basal cell carcinomas of the skin.
b. One squamous cell carcinoma of the skin not worse than Stage T1 that has been successfully treated, with no signs of recurrence or metastases for at least the past 2 years.
c. Actinic keratosis.
d. Squamous cell carcinoma in situ of the skin successfully treated >6 months.
e. Localized carcinoma in situ of the cervix treated and considered cured.
17. History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease.
18. Primary immunodeficiencies, prior splenectomy, or suppressive conditions, including subjects taking immunosuppressive therapy following organ transplants.
19. Had major surgery (e.g., hip replacement, aneurysm removal) within 6 months or is planning to have major surgery during the study.
20. History or concurrent clinically significant medical conditions or any other reason, including any physical, psychological, or psychiatric condition, that would compromise the safety or interfere with the subject’s participation in the study, would make the participant an unsuitable candidate to receive study drug, or would put the participant at risk.
21. Has received live (including attenuated) vaccination within 8 weeks or planned during the study and up to at least 12 weeks after the last dose of study drug.
22. Has received Bacillus Calmette-Guérin vaccination within 1 year.
23. Presence of active suicidal ideation, or positive suicidal behavior; any history of suicidal attempt (including an actual attempt, interrupted attempt, or aborted attempt), or suicidal ideation in the past 6 months.
24. Presence of moderately severe depression or severe depression. Subjects are permitted to use 1 medication to treat depression provided dose is stable for 4 weeks prior. Subjects on multiple medications for depression are excluded from the study.
25. Severe cardiovascular comorbidities including history of myocardial infarction, unstable angina pectoris, stroke or heart failure New York Heart Association (NYHA) III or IV), or uncontrolled hypertension.
26. Clinically significant ECG abnormalities on centrally read ECG at the Screening.
27. Subject with laboratory abnormalities at the Screening.
28. Subject is enrolled in another interventional investigational study for a device or drug or has been so enrolled in the last 28 days prior or within 5 half-lives of the study drug prior to the Screening, whichever is longer.
29. Subject is pregnant or breastfeeding or plans to become pregnant while enrolled in the study
and up to 12 weeks after the last dose of study drug;
30. History of chronic alcohol or drug abuse in the past year.
31. Subject is an employee, or direct relative of an employee, of the sponsor, at a study site, or of a third-party organization involved in the study.

E.5 End points

E.5.1

Primary end point(s)

1. Percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75 at Week 12, 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.

E.5.1.1

Timepoint(s) of evaluation of this end point

From baseline to week 12.

E.5.2

Secondary end point(s)

1. Proportion of participants achieving HiSCR50 at Week 12.
2. Change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 12;
3. Proportion of participants achieving a Dermatology Life Quality Index (DLQI) total score of ≤5 at Week 12.
4. Proportion of participants achieving at least 30% reduction and at least 1-unit reduction from baseline in Numerical Rating Scale (NRS) 30 in Patient's Global Assessment (PGA) of Skin Pain at Week 12 among subjects with baseline NRS ≥3.

E.5.2.1

Timepoint(s) of evaluation of this end point

From baseline to week 12.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Immunogenicity

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Canada

United States

Poland

Bulgaria

Netherlands

Germany

Ireland

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

189

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

117

F.4.2.2

In the whole clinical trial

210

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2022-04-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-06-27

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2023-08-30

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