Efficacy, Safety, and Tolerability of HB0043 in Hidradenitis Suppurativa Patients.

Launched by SHANGHAI HUAOTA BIOPHARMACEUTICAL CO., LTD. · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HB0043 for adults with a skin condition known as Hidradenitis Suppurativa (HS). HS causes painful lumps and abscesses in areas like the armpits and groin. The goal of the study is to find out if HB0043 is effective, safe, and well-tolerated by patients who have moderate to severe HS. If you are at least 18 years old, have been diagnosed with HS for at least six months, and have specific symptoms, you might be eligible to participate.

During the trial, participants will receive the treatment and be monitored for its effects and any side effects. It's important to note that women of childbearing age will need to agree to use reliable birth control throughout the study. If you have certain health conditions, such as other autoimmune diseases or a history of serious infections, you may not be able to join the trial. Overall, this study aims to help improve treatment options for those suffering from HS, making it an important opportunity for eligible patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * 1. Understand the research procedure of this study and provide written informed consent; 2. Male or female, age 18 years or greater; 3. Diagnosis of HS with a disease duration of at least 6 months before screening; 4. Moderate to severe HS, concurrently meeting the following three criteria:
• • 1. HS lesions in at least 2 distinct anatomic area;
• • 2. One of the HS lesions must be Hurley Stage II or Hurley Stage III;
• • 3. Total abscess and inflammatory nodule (AN) count of greater than or equal to 3; 5. Acceptance by the patient, of childbearing age, to use safe contraceptive methods throughout the study, including six months of follow-up.
• Exclusion Criteria:
• • 1. Participants with known hypersensitivity to HB0043 or any of its excipients; 2. Participant has a draining fistula count of ≥20 at the Screening Visit; 3. Presence of other active autoimmune diseases except HS, including but not limited to psoriasis, psoriatic arthritis, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, and uveitis; 4. Participant has any other active skin disease or condition that may interfere with the assessment of hidradenitis suppurativa; 5. History of lymphoproliferative disorders or any known malignancy within five years prior to the Screening Visit (excluding treated and cured cutaneous squamous cell carcinoma, basal cell carcinoma, carcinoma uterine in situ, or intraductal breast cancer in situ); 6. History of recurrent or recent serious infection; 7. Participant has active tuberculosis (TB) or concurrent treatment for latent TB or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection; 8. Pregnant or lactating women; 9. Any reason why, in the opinion of the investigator, the patient should not participate.