Phase 3 Randomized, Double‑Blind, Placebo‑Controlled Study of Subcutaneous Sonelokimab in Adults with Moderate‑to‑Severe Hidradenitis Suppurativa
- Trial ID
- 2024-511360-87-00
- Protocol
- M1095-HS-301
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to demonstrate the **efficacy** of sonelokimab compared with placebo in achieving HiSCR75 over 16 weeks of treatment in participants with moderate to severe **hidradenitis suppurativa** (HS). This is clinically relevant as achieving HiSCR75, which indicates a 75% reduction in inflammatory nodules and abscesses, is a significant marker of disease improvement and can lead to enhanced quality of life for patients suffering from this chronic condition.
Secondary objectives include:
- Evaluating the efficacy of sonelokimab compared with placebo based on other clinical measures of disease activity over 16 weeks of treatment in participants with moderate to severe HS.
- Assessing the safety and tolerability of sonelokimab over 52 weeks of treatment in participants with moderate to severe HS.
- Assessing the change from baseline to Week 52 in efficacy measures in participants with moderate to severe HS.
Participants
The clinical trial involves a total of **138 participants** diagnosed with **hidradenitis suppurativa (HS)**, a chronic inflammatory skin condition. The study population includes both male and female subjects, aged 18 years and older, who have been diagnosed with moderate to severe HS. Participants were selected based on their inadequate response to systemic antibiotics or intolerance to such treatments, as determined by the investigator. The trial does not include a vulnerable population. Participants are required to maintain a stable dose of antibiotics if enrolled in the antibiotic cohort. Lifestyle considerations such as diet and physical activity are not specified. The trial ensures that female participants of childbearing potential use highly effective contraception methods, and male participants agree to use condoms and refrain from sperm donation during and after the study period. The selection criteria emphasize the ability to provide informed consent and compliance with study requirements.
Plans and Procedures
The clinical trial is a **randomized**, **double-blind**, **placebo-controlled** study designed to evaluate the efficacy and safety of subcutaneous **sonelokimab** in adult participants with moderate to severe **hidradenitis suppurativa**. The trial is set to commence on September 1, 2024, and is expected to conclude by April 30, 2026. The primary objective is to demonstrate the efficacy of sonelokimab compared to placebo with respect to achieving a 75% improvement in the Hidradenitis Suppurativa Clinical Response (HiSCR) score over 16 weeks of treatment. Secondary endpoints include the assessment of treatment-emergent adverse events, serious adverse events, and other clinical parameters.
Participants will be involved in the study for a maximum treatment period of 48 weeks. The trial will begin with a screening visit to confirm eligibility based on inclusion criteria, such as age, previous treatment response, and contraceptive use for women of childbearing potential. Following randomization, participants will receive either sonelokimab or placebo via subcutaneous injection. Study visits will occur at regular intervals to monitor safety, efficacy, and adherence to the protocol. These visits will include physical examinations, vital signs assessments, and laboratory tests.
The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to evaluate the overall treatment outcomes. Participants may be withdrawn from the study early if they experience significant adverse events, fail to comply with the study protocol, or choose to withdraw consent. The trial's design ensures rigorous monitoring and data collection to support the evaluation of sonelokimab's therapeutic potential in treating hidradenitis suppurativa.
Treatment
The clinical trial involves the administration of **Sonelokimab**, an experimental medication designed for the treatment of moderate to severe **Hidradenitis Suppurativa**. Sonelokimab is a nanobody that inhibits **IL-17A** and **IL-17F**, and is provided in the form of an injection. The pharmaceutical form is a subcutaneous injection, with a maximum daily dose of 120 mg/ml and a total maximum dose of 1620 mg/ml over a treatment period of 48 weeks. The medication is administered via subcutaneous injection, and the dosing schedule is determined based on the study protocol. Compliance with the dosing regimen is monitored throughout the trial to ensure adherence to the treatment plan.
The study also includes a **placebo** control, which is a sterile solution provided in a single-use prefilled syringe intended for subcutaneous administration. The placebo is used to maintain the double-blind nature of the trial, allowing for an unbiased comparison of the efficacy and safety of Sonelokimab. The placebo is administered in the same manner as the experimental medication, ensuring consistency in the administration process. Participant compliance with the placebo administration is similarly monitored to maintain the integrity of the study results.
Efficacy
The efficacy of the investigational product, **Sonelokimab**, will be assessed in a phase 3, randomized, double-blind, placebo-controlled, multicenter study involving adult participants with moderate to severe **Hidradenitis Suppurativa** (HS). The primary endpoint for evaluating efficacy is the percentage of participants achieving a 75% improvement in the Hidradenitis Suppurativa Clinical Response (HiSCR) score at Week 16. Secondary endpoints include the percentage of participants achieving a 50% improvement in HiSCR score at Week 16, absolute change in the International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 16, and the percentage of participants achieving a Dermatology Life Quality Index (DLQI) total reduction of ≥4 at Week 16 among those with a baseline DLQI ≥4.
Additional secondary endpoints involve the percentage of participants achieving a ≥30% reduction and a ≥2-unit reduction at Week 16 in the Numerical Rating Scale (NRS30) for pain in the Patient Global Assessment (PGA) among participants with a baseline NRS ≥3, and the percentage of participants achieving a ≥3-unit reduction at Week 16 in the NRS for pain in PGA among participants with a baseline NRS ≥3. Efficacy assessments will be conducted at specified timepoints, including Week 16, using validated scales and patient-reported outcomes. The data collected will be analyzed to determine the efficacy of Sonelokimab in comparison to placebo in achieving the desired clinical response in participants with moderate to severe HS.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Participants must be at least 18 years of age at the time of signing the informed consent
- Participants must complete at least 4 out of 7 days of eDiary entries in at least 1 of the 2 weeks before randomization.
- Participants who have 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), in the investigator’s opinion. Typical duration of treatment before an inadequate response is declared should be no less than 8 to 12 weeks in accordance with to the recommendations in US and European guidelines.
- Participants enrolling in the antibiotic cohort must be on a stable dose (defined as a dose or dose regimen that has not changed in the previous 28 days before the initiation of study treatment).
- Female participants are eligible to participate if they are not pregnant or breastfeeding and must be of nonchildbearing potential or (if WOCBP) must agree to use highly effective methods of contraception during the study and for at least 8 weeks after the last dose of study treatment. WOCBP must have a negative urine pregnancy test at screening and a negative urine pregnancy test at Week 0/Day 1 before initiation of study treatment. Female participant of childbearing potential must refrain from donating oocytes during the study and for at least 8 weeks after the last dose of study treatment. See Appendix 4 for the definition of nonchildbearing potential, childbearing potential, and highly effective methods of contraception.
- Male participants must be willing to use a condom when sexually active with a WOCBP partner during the study and for at least 8 weeks after the last dose of study treatment, unless surgically sterile. Male participants must also agree to refrain from donating sperm during the study and for at least 8 weeks after the last dose of study treatment.
- Participants must be capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
- 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.
Exclusion Criteria
- Participants with a known hypersensitivity to sonelokimab or any of its excipients.
- Participants with evidence of tuberculosis (TB) infection (active, history of active, latent or history of latent) at the Screening Visit. Participants may still enter the study if they have documented evidence that they have completed sufficient treatment, according to local routine clinical practice, at least 4 weeks before randomization. If they completed their treatment at least 4 weeks before and within 24 months of the Baseline Visit, to be enrolled they need to have documented evidence of treatment and have no evidence of active or latent disease. If they completed their treatment over 24 months before baseline, to be enrolled they need to have been adequately treated and confirmed to be fully recovered upon consultation with a TB specialist (see Section 8.1.3).
- Participants with any current nontuberculous mycobacterial infection or any history of nontuberculous mycobacterial infection at the Screening Visit.
- Participants with a concurrent acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at the Screening Visit.
- Participants with evidence of human immunodeficiency virus (HIV) infection at the Screening Visit.
- Participants with a concurrent malignancy or a history of malignancy within 5 years of the initiation of study treatment with the following exceptions: a. Three or fewer 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 before study treatment initiation. c. Actinic keratosis. d. Squamous cell carcinoma in situ of the skin successfully treated >6 months before study treatment initiation. e. Localized carcinoma in situ of the cervix treated and considered cured.
- Participants with a history of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease.
- Participants with primary immunodeficiencies, prior splenectomy, or suppressive conditions, including participants taking immunosuppressive therapy following organ transplants.
- Participants who currently use or plan to use one or more prohibited treatments specified in this protocol unless permitted according to criteria in Section 6.9.1, including high-potency opioid analgesics [eg, methadone, hydromorphone, or morphine], GLP-1 analogs, or ongoing use of prohibited HS treatments/medications [eg, systemic or topical corticosteroids] at baseline).
- Participants who are enrolled in another interventional investigational study for a device or drug or have been so enrolled in the last 28 days before the initiation of study treatment or within 5 half-lives of the investigational study drug before the initiation of study treatment, whichever is longer.
- Participants with clinically significant electrocardiogram (ECG) abnormalities on centrally read ECG at the Screening Visit. Clinically significant ECG abnormalities are considered changes that often indicate underlying cardiac conditions that may require immediate medical attention.
- Participants with laboratory abnormalities at the Screening Visit, including any of the following:a. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP) >3× upper limit of normal (ULN). b. Serum direct bilirubin >1.5×ULN (in the absence of known Gilbert syndrome). c. White blood cell count <3×10^9/L. d. Absolute neutrophil count <1.5×10^9/L. e. Absolute lymphocyte count <0.7×10^9/L. f. Platelet count <100×10^9/L. g. Hemoglobin <85 g/L. h. Creatinine clearance <30 mL/min (by Cockcroft Gault formula).
- Any other laboratory abnormality which, in the opinion of the investigator, might compromise participant’s safety, prevent the participant from completing the study or would interfere with the interpretation of the study results.
- Participants who have had major surgery (e.g., hip replacement, aneurysm removal) within 6 months before the initiation of study treatment or are planning to have major surgery during the study.
- Participants with any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of HS.
- Participants who have a history of chronic alcohol or drug abuse in the past year before the Screening Visit
- Participants who are an employee or a direct relative of an employee of the sponsor, a study center, or a third-party organization involved in the study.
- Participants with underlying conditions (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, or cardiac) that, in the opinion of the investigator, potentially places the participant at unacceptable risk.
- Participants with current severe or uncontrolled disease(s) that put(s) the participant at increased risk, including any medical or psychiatric condition that, in the investigator’s opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
- 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, prevent participants from complying with protocol requirements (including the requirement for prohibited medications), or put the participant at undue risk.
- Participants with a confirmed or suspected diagnosis of inflammatory bowel disease (eg, ulcerative colitis or Crohn’s disease), either in medical history or currently present. Note: participants with functional gastrointestinal disorders (eg, irritable bowel syndrome) can be considered eligible for enrolment if inflammatory bowel disease has been excluded and documented (eg, formal clinical criteria, endoscopy, fecal calprotectin stool test).
- Participants who have experienced a period of ≥3 weeks of unexplained diarrhea in the 24 weeks before the initiation of study treatment.
- Participants with an active infection or history of infections including any of the following: a. Any infection (exception: common cold) requiring systemic anti-infective treatment within 14 days before initiation of study treatment. b. Serious infection, defined as requiring hospitalization or intravenous anti-infectives, within 2 months before initiation of study treatment. c. Candida infection requiring systemic therapy for ≥7 days in the last 12 months before initiation of study treatment. d. Previous esophageal or systemic candidiasis. e. Current active candidiasis or Candida infection within the last 3 months before the initiation of study treatment.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Austria | Not Recruiting | 01 Sept 2024 | 3 |
 Bulgaria | Not Recruiting | 01 Sept 2024 | 18 |
 Germany | Not Recruiting | 01 Sept 2024 | 63 |
 Hungary | Not Recruiting | 01 Sept 2024 | 20 |
 Italy | Not Recruiting | 01 Sept 2024 | 56 |
 Norway | Not Recruiting | 01 Sept 2024 | 8 |
 Poland | Not Recruiting | 01 Sept 2024 | 80 |
 Portugal | Not Recruiting | 01 Sept 2024 | 14 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Sonelokimab | Test | INJECTION | SUBCUTANEOUS INJECTION | 120 | 48 | PRD10271602 |
Placebo is a sterile solution in a single use prefilled syringe (PFS) intended for subcutaneous administration | Placebo | N/A | — | — | — | N/A |