## Protocol Section
### Identification Module
**NCT ID:** NCT06411379

**Brief Title:** Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

**Official Title:** A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

#### Organization Study ID Info
**ID:** M1095-HS-302
#### Organization
**Class:** INDUSTRY
**Full Name:** MoonLake Immunotherapeutics AG
#### Secondary ID Infos
**Domain:** Sponsor
**ID:** VELA-2
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2026-06-17

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-13

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-08

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06-17

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-22

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-13
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** MoonLake Immunotherapeutics AG

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This is a study to evaluate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa. Participants will be randomized 2:1 to either sonelokimab or matching placebo up to Week 16.

### Conditions Module

**Conditions:**

- Hidradenitis Suppurativa

**Keywords:**

- Hidradenitis Suppurativa

- Hidradenitis

- Sweat Gland Diseases

- Skin Diseases

- Skin Diseases, Bacterial

- Suppuration

- Anti-Inflammatory Agents

- Sonelokimab

- Nanobody

- Apocrine Gland Disease

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 400

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Subjects randomized to this arm will receive sonelokimab from Weeks 0-48.

**Intervention Names:**

- Drug: Sonelokimab

**Label:** sonelokimab

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Subjects randomized to this arm will receive placebo from Weeks 0-16. They will receive sonelokimab from weeks 16-48

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- sonelokimab

**Description:** Sonelokimab

**Name:** Sonelokimab

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Placebo

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**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.

**Measure:** Hidradenitis Suppurativa Clinical Response 75

**Time Frame:** Week 16

#### Secondary Outcomes

**Description:** Percentage of participants achieving HiSCR50

**Measure:** Hidradenitis Suppurativa Clinical Response 50

**Time Frame:** Week 16

**Description:** Absolute change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4)

The IHS4 score is calculated as follows: number of nodules (multiplied by 1) + number of abscesses (multiplied by 2) + 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.

**Measure:** Change in International Hidradenitis Suppurativa Severity Score System

**Time Frame:** Week 16

**Description:** Percentage of participants achieving a DLQI total reduction of ≥4 minimal clinically important difference among participants with a baseline DLQI ≥4

**Measure:** Dermatology Life Quality Index (DLQI)

**Time Frame:** Week 16

**Description:** Percentage of participants achieving at least ≥30% (and ≥50%) reduction and at least 2-unit reduction from Baseline in Numerical Rating Scale (NRS30 \& NRS50) in Patient's Global Assessment of Skin Pain (PGA Skin Pain) among subjects with Baseline NRS ≥3

**Measure:** Reduction from Numerical Rating Scale (NRS30 & NRS50) in Patient's Global Assessment of Skin Pain (PGA Skin Pain)

**Time Frame:** week 16

**Description:** Patient Global Impression - Severity of Illness - Hidradenitis Suppurativa at Week 16

**Measure:** Patient Global Impression - Severity of Illness - Hidradenitis Suppurativa at Week 16

**Time Frame:** Week 16

**Description:** Resolution of draining tunnels (DT100)

**Measure:** Resolution of draining tunnels (DT100)

**Time Frame:** Week 16 and Week 52

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Participants must be at least 18 years of age at the time of signing the informed consent.
2. Participants who are diagnosed with hidradenitis suppurativa as determined by the investigator and have a history of signs and symptoms of hidradenitis suppurativa for at least 6 months before signing the informed consent.
3. Participants who have 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.
4. Participants who have a total AN count of ≥5.
5. Participants who have HS lesions present in ≥2 distinct anatomical areas, at least one of which must contain single or multiple fistulas (ie, be Hurley Stage II or III).

Exclusion Criteria:

1. Participants with a known hypersensitivity to sonelokimab or any of its excipients.
2. Participants with any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of HS.
3. Participants with underlying conditions that, in the opinion of the investigator, potentially places the participant at unacceptable risk.
4. Participants with current severe or uncontrolled disease(s) that put(s) the participant at increased risk in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
5. Participants with any other known autoimmune disease or any medical condition that in the opinion of the investigator would interfere with an accurate assessment of clinical symptoms of HS.
6. Participants with a gastrointestinal condition including inflammatory bowel disease or diagnosis of ulcerative colitis or Crohn's disease.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ClinicalTrials@moonlaketx.com

**Name:** Moonlake Clinical Trial Helpdesk

**Phone:** +41 41 510 8022

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** MoonLake Immunotherapeutics AG

**Name:** Prof Kristian Reich, M.D., Ph.D. (equ.)

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000013543

- Term: Sweat Gland Diseases

- ID: D000012871

- Term: Skin Diseases

- ID: D000017192

- Term: Skin Diseases, Bacterial

- ID: D000001424

- Term: Bacterial Infections

- ID: D000001423

- Term: Bacterial Infections and Mycoses

- ID: D000007239

- Term: Infections

- ID: D000012874

- Term: Skin Diseases, Infectious

- ID: D000013492

- Term: Suppuration

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M16273

- Name: Suppuration

- Relevance: LOW

- As Found: Unknown

- ID: M19762

- Name: Hidradenitis Suppurativa

- Relevance: HIGH

- As Found: Hidradenitis Suppurativa

- ID: M18964

- Name: Hidradenitis

- Relevance: HIGH

- As Found: Hidradenitis

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M19500

- Name: Skin Diseases, Bacterial

- Relevance: LOW

- As Found: Unknown

- ID: M16323

- Name: Sweat Gland Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4722

- Name: Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M12136

- Name: Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M4721

- Name: Bacterial Infections and Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M15677

- Name: Skin Diseases, Infectious

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000017497

- Term: Hidradenitis Suppurativa

- ID: D000016575

- Term: Hidradenitis

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
