VENT-03 for Cutaneous lupus erythematosus

Inclusion criteria

• {"criterion_text":"- Male or female participants of age 18 to 70 years, inclusive.\n- Body weight within the range of 40 to 110 kg (88 to 242 lbs), (inclusive).\n- Has provided written informed consent\n- Participants of childbearing potential, participants who are not post-menopausal or surgically sterile must agree to use a highly effective method of contraception from ≥ 30 days prior to dosing through 30 days after the last IMP administration.\n- Participants (or partners of POCBP) who can produce sperm must use a highly effective methods of contraception from ≥ 30 days prior to dosing through 90 days after the last IMP administration. Participants who can produce sperm must agree to not donate sperm through 90 days after the last IMP administration.*\n- Participant is, per the investigator’s assessment, reliable and willing to be available for the duration of the study and is willing and able to perform and follow all study procedures and requirements.\n- Cutaneous lupus at Screening"}

Exclusion criteria

• {"criterion_text":"- Has any clinical condition or clinically significant abnormality at Screening that in the opinion of the Investigator would interfere with evaluation of the IMP, affect participant safety, or interpretation of study results\n- Participant is involved with the conduct of the study, or is an employee, or immediate family member of individuals involved with the conduct of the study.\n- Had a major surgery within 8 weeks before Day 1 or elective major surgery planned during thestudy period.\n- Pregnant or nursing.\n- Known hypersensitivity to any components of the VENT-03 formulation.\n- Poor venous access.\n- Currently enrolled in any other interventional clinical trial involving an investigational product within 30 days or 5 half-lives (whichever is longer) prior to dosing or enrolled in any other type of medical research.\n- History of alcohol or substance use disorder in the 12 months prior to Screening or positive drug test at Screening.\n- Regular use of > 1 nonsteroidal anti-inflammatory drug (NSAID) within 2 weeks prior to Day 1 or receipt of fluctuating doses of a NSAID within 2 weeks prior to Day 1.\n- Use of any restricted medications within the stated washout period\n- Intra-articular, intramuscular or IV glucocorticosteroids within 6 weeks prior to Day 1\n- Any live or attenuated vaccine within 8 weeks prior to signing the ICF or Bacillus Calmette-Guerin (BCG) vaccine within 1 year prior to Day 1. Administration of killed vaccines is acceptable;\n- Blood transfusion within 4 weeks prior to Day1.\n- Patient is taking a strong inhibitor or inducer of CYP2C8 or CYP1A2 Patient is taking a strong inhibitor of the BCRP transporter Patient is taking a narrow therapeutic index medication that is a substrate of CYP2C8 or CYP2C9 Patient is taking a narrow therapeutic index medication that is a substrate of the BCRP, OAT1, OAT3, OATP1B1 or OATP1B3 transporters\n- Has drug induced lupus, rather than “idiopathic” lupus.\n- History of, or current, inflammatory joint or skin disease other than SLE and cutaneous lupus, including other autoimmune that, in the opinion of the Investigator, could interfere with disease activity assessments\n- Diagnosis of mixed connective tissue disease or any history of overlap syndromes of SLE or systemic sclerosis (SSc) within 1 year prior to signing the ICF\n- History of, or current diagnosis of, a clinically significant non SLE-related vasculitis syndrome. Vasculitis due to SLE is permissible.\n- Active severe or unstable neuropsychiatric SLE\n- Active severe SLE-driven renal disease\n- History or current diagnosis of catastrophic or severe anti-phospholipid syndrome within 1 year prior to Day 1.\n- History of any non-lupus disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to Day 1.\n- Known history of a primary (HIV)\n- Latent or active tuberculosis (TB)\n- Confirmed positive test on hepatitis B serology\n- Positive test for hepatitis C antibody\n- History of any severe herpes infection\n- Herpes zoster\n- Opportunistic infection requiring hospitalization.\n- Use of any restricted medications within the stated washout period"}

Primary endpoints

• {"endpoint_text":"- Change from baseline in CLASI-A score on Day 28","definition_or_measurement_approach":"Change from baseline in CLASI-A (Cutaneous Lupus Erythematosus Disease Area and Severity Index activity) score measured on Day 28."}

Secondary endpoints

• {"endpoint_text":"- Treatment-emergent adverse events (TEAEs), vital signs, electrocardiogram (ECG), physical examination, and safety laboratory assessments","definition_or_measurement_approach":"Safety assessments including monitoring and reporting of TEAEs, vital signs, ECGs, physical examinations and safety laboratory tests."}
• {"endpoint_text":"- Change from baseline in MXA immunostaining in lesional skin biopsy","definition_or_measurement_approach":"Pharmacodynamic assessment using Myxovirus-resistant protein A (MXA) immunostaining on lesional skin biopsy; change from baseline measured histologically/immunohistochemically."}
• {"endpoint_text":"- Plasma concentrations and PK parameters of VENT-03","definition_or_measurement_approach":"Pharmacokinetic analysis measuring plasma concentrations of VENT-03 and deriving PK parameters from plasma samples."}

Methods

• Online advertising: Facebook ads and web banner ads (country-specific languages) as indicated in recruitment materials for Czech Republic, Spain, Poland, Bulgaria, France and Hungary.
• Printed and onsite materials: Study posters, brochures and patient letters distributed at participating sites.
• Healthcare professional outreach: HCP letters and HCP factsheets to dermatology and rheumatology clinics to identify potential participants.
• Telephone pre-screening and Scout recruitment: Scout Clinical telephone contact and pre-ICF telephone data consent used for pre-screening and recruitment.
• Participant-facing materials and guides: ICF flipbooks, study visit guides and participant cards available in country-specific documents.

Czechia

Earliest CTIS Part Ii Submission Date

30-07-2025

Latest Decision Or Authorization Date

26-08-2025

Processing Time Days

27

Number Of Sites

1

Number Of Participants

1

Spain

Earliest CTIS Part Ii Submission Date

08-08-2025

Latest Decision Or Authorization Date

28-08-2025

Processing Time Days

20

Number Of Sites

2

Number Of Participants

1

Poland

Earliest CTIS Part Ii Submission Date

13-08-2025

Latest Decision Or Authorization Date

01-09-2025

Processing Time Days

19

Number Of Sites

8

Number Of Participants

7

France

Earliest CTIS Part Ii Submission Date

13-08-2025

Latest Decision Or Authorization Date

27-08-2025

Processing Time Days

14

Number Of Sites

2

Number Of Participants

1

Bulgaria

Earliest CTIS Part Ii Submission Date

15-08-2025

Latest Decision Or Authorization Date

28-08-2025

Processing Time Days

13

Number Of Sites

3

Number Of Participants

2

Hungary

Earliest CTIS Part Ii Submission Date

15-07-2025

Latest Decision Or Authorization Date

28-08-2025

Processing Time Days

44

Number Of Sites

2

Number Of Participants

1

Primary sponsor

Full Name

Ventus Therapeutics U.S. Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

Multiple operational responsibilities (codes include 1,10,12,13,15,2,4,5,6,8,9) and 'Central reading of ECGs' per sponsor duties.

Name

Imperial Clinical Research Services International Ltd.

Responsibilities

Printing

Name

Almac Clinical Services Limited

Responsibilities

Code 14 (role per sponsor duties)

Third parties

• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Imperial Clinical Research Services International Ltd.","duties_or_roles":"Printing","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Universitaetsklinikum Bonn AöR","duties_or_roles":"4","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Clario Medical Imaging Inc.","duties_or_roles":"ePRO","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Koneksa Health Inc.","duties_or_roles":"Digital Health Technology","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"University Of Michigan","duties_or_roles":"4","organisation_type":"Educational Institution"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Universitaetsklinikum Bonn AöR","duties_or_roles":"4","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Codes: 1,10,12,13,15,2,4,5,6,8,9 (includes 'Central reading of ECGs')","organisation_type":"Pharmaceutical company"}
• {"country":"South Africa","full_name":"Synexa Life Sciences (Pty) Ltd.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"14","organisation_type":"Pharmaceutical company"}