Hidradenitis SuppurativaPhase 3NCT06768671
An Open-label, Single-arm Study to Evaluate Pharmacokinetics and Safety of Subcutaneous Sonelokimab in Adolescents With Moderate to Severe Hidradenitis Suppurativa (VELA-TEEN)
A Phase 3 study testing Sonelokimab in people with Hidradenitis Suppurativa, run by MoonLake Immunotherapeutics AG at 18 sites in United States.
Trial summary
This is a study to evaluate the pharmacokinetic (PK) and safety of sonelokimab in adolescent patients with HS. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Sonelokimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 18 sitesUnited States
- Study dates
- 30 Dec 2024to 28 Sep 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants must be between ≥12 and ≤17 years of age at the time of signing the informed consent.
- Participants who are diagnosed with HS as determined by the investigator and have a history of signs and symptoms of HS for ≥6 months before signing the informed consent.
- Participants who have moderate to severe HS as determined by the refined Hurley staging (Stages IB and IC, IIB and IIC, and III).
- Participants who have had an inadequate response to appropriate systemic antibiotics for treatment of HS .
- Participants must be up to date with age-appropriate vaccine requirements 8 weeks prior to entry in the study.
- Participants with a body weight of ≥ 40 kg.
Who cannot join
- Participants with a known hypersensitivity to sonelokimab or any of its excipients.
- Participants with a draining fistula count of ≥20 at the Screening Visit.
- Participants with any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of HS.
- Participants with underlying conditions that, in the opinion of the investigator, potentially compromise the participant and/or places the participant at unacceptable risk.
- Participants who have history or concurrent clinically significant medical conditions or any other reason, including any physical, psychological, or psychiatric condition, that in the opinion of the investigator would compromise the safety or interfere with participation in the study, would make the participant an unsuitable candidate to receive study drug, or would put the participant at risk.
- Participants with any other skin disease or other medical condition that in the opinion of the investigator would interfere with an accurate assessment of clinical symptoms of HS.
- Participants with a confirmed or suspected diagnosis of inflammatory bowel disease.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Clinical Site
Charleston, South Carolina, 29425
Clinical Site
Chicago, Illinois, 60611
Clinical Site
Columbus, Indiana, 47201
Clinical Site
Dallas, Texas, 75246
Clinical Site
Dallas, Texas, 75390-8575
Clinical Site
Fargo, North Dakota, 58103
Clinical Site
Hollywood, Florida, 33201
Clinical Site
Macon, Georgia, 31217
Clinical Site
Miami, Florida, 33136
Clinical Site
Murray, Kentucky, 42071
Clinical Site
Norfolk, Virginia, 23502
Clinical Site
North Little Rock, Arkansas, 72117
Clinical Site
San Antonio, Texas, 78218
Clinical Site
Sandy Springs, Georgia, 30328
Clinical Site
Seattle, Washington, 98105
Clinical Site
Stanford, California, 94304
Clinical Site
Washington D.C., District of Columbia, 20010
Clinical Site
Waterford, Michigan, 48328
About this study
Official title: An Open-label, Single-arm Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Sonelokimab in Adolescents Aged ≥12 to ≤17 Years at the Time of Study Inclusion With Active Moderate to Severe Hidradenitis Suppurativa
This is a study to evaluate the pharmacokinetic (PK) and safety of sonelokimab in adolescent patients with HS.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Sonelokimab
- Keywords
- Hidradenitis Suppurativa, Hidradenitis, Sweat Gland Diseases, Skin Diseases, Skin Diseases, Bacterial, Suppuration, Anti-Inflammatory Agents, Sonelokimab, Nanobody, Apocrine Gland Disease
- Medical subject headings
- Hidradenitis Suppurativa, Hidradenitis, Sweat Gland Diseases, Skin Diseases, Skin Diseases, Bacterial, Suppuration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonelokimabDrug
Open label
| Study group | Role | What they receive |
|---|---|---|
| sonelokimab | Experimental | Subjects will receive sonelokimab 120mg subcutaneously (SC) as an induction regimen of 4 doses, followed by sonelokimab SC every 4 weeks maintenance dose starting at Week 8 Receives: Drug: Sonelokimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) of sonelokimab in adolescents
PK (trough concentrations) of sonelokimab over 24 weeks of treatment
Measured: Week 24
Adverse events (AEs) following treatment with sonelokimab in adolescents
Incidence, relatedness, severity and seriousness of all AEs over 24 weeks of treatment from baseline
Measured: Week 24
Discontinuation of sonelokimab treatment due to AEs
Number of participants discontinued from sonelokimab treatment due to AE over 24 weeks of treatment from baseline
Measured: Week 24
Clinically significant changes in clinical laboratory parameters
Number of participants with clinically significant changes in hematology, biochemistry and urinalysis from baseline
Measured: Week 24
Clinically significant changes in vital signs
Number of participants with clinically significant changes in vital signs from baseline
Measured: Week 24
Clinically significant changes in standard 12-lead electrocardiogram (ECG) intervals
Number of participants with clinically significant changes in 12-lead ECG intervals from baseline
Measured: Week 24
Secondary outcomes (5)
Hidradenitis Suppurativa Clinical Response (HiSCR)75
Percentage of participants achieving a HiSCR75 response over time
Measured: Week 24
Hidradenitis Suppurativa Clinical Response (HiSCR) 50
Percentage of participants achieving a HiSCR50 response over time
Measured: Week 24
International Hidradenitis Suppurativa Severity Score System (IHS4)
Absolute change in IHS4 score over time
Measured: Week 24
Children's Dermatology Life Quality Index (CDLQI)
Percentage of participants achieving a CDLQI total reduction of ≥2.5 over time among participants with a baseline CDLQI ≥2.5
Measured: Week 24
Numerical Rating Scale (NRS) 30
Percentage of participants achieving a ≥30% reduction and a ≥2-unit reduction over time in the NRS30 for pain in PGA among participants with a baseline NRS ≥3
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start30 Dec 2024
- Primary completion28 Sep 2026 (estimated)
- Study completion28 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MoonLake Immunotherapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768671
- Sponsor's protocol ID
- M1095-HS-304
- Status last verified
- May 2026
- First submitted
- 29 Nov 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Sonelokimab in Adolescents Aged ≥12 to ≤17 Years at the Time of Study Inclusion With Active Moderate to Severe Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT06768671
- Acronym / sponsor ID
- M1095-HS-304
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis Suppurativa, Hidradenitis, Sweat Gland Diseases, Skin Diseases, Skin Diseases, Bacterial, Suppuration, Anti-Inflammatory Agents, Sonelokimab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- MoonLake Immunotherapeutics AGIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 28 Sep 2026 (estimated)
- Study completion
- 28 Sep 2026 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to evaluate the pharmacokinetic (PK) and safety of sonelokimab in adolescent patients with HS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sonelokimab | Experimental | Drug: SonelokimabSubjects will receive sonelokimab 120mg subcutaneously (SC) as an induction regimen of 4 doses, followed by sonelokimab SC every 4 weeks maintenance dose starting at Week 8 |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Participants must be between ≥12 and ≤17 years of age at the time of signing the informed consent.
- Participants who are diagnosed with HS as determined by the investigator and have a history of signs and symptoms of HS for ≥6 months before signing the informed consent.
- Participants who have moderate to severe HS as determined by the refined Hurley staging (Stages IB and IC, IIB and IIC, and III).
- Participants who have had an inadequate response to appropriate systemic antibiotics for treatment of HS .
- Participants must be up to date with age-appropriate vaccine requirements 8 weeks prior to entry in the study.
Key exclusion criteria (7 listed)
- Participants with a known hypersensitivity to sonelokimab or any of its excipients.
- Participants with a draining fistula count of ≥20 at the Screening Visit.
- Participants with any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of HS.
- Participants with underlying conditions that, in the opinion of the investigator, potentially compromise the participant and/or places the participant at unacceptable risk.
- Participants who have history or concurrent clinically significant medical conditions or any other reason, including any physical, psychological, or psychiatric condition, that in the opinion of the investigator would compromise the safety or interfere with participation in the study, would make the participant an unsuitable candidate to receive study drug, or would put the participant at risk.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SonelokimabOpen label | Drug | sonelokimab |
Primary outcome
Pharmacokinetics (PK) of sonelokimab in adolescents
Time frame: Week 24
PK (trough concentrations) of sonelokimab over 24 weeks of treatment
Adverse events (AEs) following treatment with sonelokimab in adolescents
Time frame: Week 24
Incidence, relatedness, severity and seriousness of all AEs over 24 weeks of treatment from baseline
Discontinuation of sonelokimab treatment due to AEs
Time frame: Week 24
Number of participants discontinued from sonelokimab treatment due to AE over 24 weeks of treatment from baseline
Clinically significant changes in clinical laboratory parameters
Time frame: Week 24
Number of participants with clinically significant changes in hematology, biochemistry and urinalysis from baseline
Clinically significant changes in vital signs
Time frame: Week 24
Number of participants with clinically significant changes in vital signs from baseline
Clinically significant changes in standard 12-lead electrocardiogram (ECG) intervals
Time frame: Week 24
Number of participants with clinically significant changes in 12-lead ECG intervals from baseline
5 secondary outcomes
Hidradenitis Suppurativa Clinical Response (HiSCR)75
Time frame: Week 24
Hidradenitis Suppurativa Clinical Response (HiSCR) 50
Time frame: Week 24
International Hidradenitis Suppurativa Severity Score System (IHS4)
Time frame: Week 24
Children's Dermatology Life Quality Index (CDLQI)
Time frame: Week 24
Numerical Rating Scale (NRS) 30
Time frame: Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sonelokimab in people with Hidradenitis Suppurativa, run by MoonLake Immunotherapeutics AG at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK) of sonelokimab in adolescents (time frame: Week 24). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.