NCT06895499 Efficacy, Safety, and Tolerability of HB0043 in Hidradenitis Suppurativa Patients.
| NCT ID | NCT06895499 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shanghai Huaota Biopharmaceutical Co., Ltd. |
| Condition | Hidradenitis Suppurativa |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-03-19 |
| Primary Completion | 2026-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 15 participants in total. It began in 2025-03-19 with a primary completion date of 2026-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to assess efficacy safety and tolerability of HB0043 in adult patients with moderate to severe HS.
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.
Frequently Asked Questions
Who can join the NCT06895499 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hidradenitis Suppurativa. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06895499 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06895499 currently recruiting?
Yes, NCT06895499 is actively recruiting participants. Visit ClinicalTrials.gov or contact Shanghai Huaota Biopharmaceutical Co., Ltd. to inquire about joining.
Where is the NCT06895499 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT06895499 clinical trial?
NCT06895499 is sponsored by Shanghai Huaota Biopharmaceutical Co., Ltd.. The trial plans to enroll 15 participants.