Efficacy, Safety, and Tolerability of HB0043 in Hidradenitis Suppurativa Patients.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HB0043, HB0043, HB0043.
- Who it may be relevant to
- Registry conditions: Hidradenitis Suppurativa. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase I/II, Open-Label, Dose-Escalation Clinical Trial to Evaluate the Safety and Efficacy of HB0043 (Bispecific Antibody Targeting IL-17A and IL-36R) in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (HS).
Overview
The purpose of this study is to assess efficacy safety and tolerability of HB0043 in adult patients with moderate to severe HS.
Detailed description
The total duration of the study is 28 weeks and consists of: Screening (up to 4 weeks), Treatment Period (20 weeks) and Safety Follow-Up (treatment-free follow-up for 4 weeks).
Participants who prematurely discontinue study treatment are encouraged to remain in the study. Participants who do not wish to remain in the study will enter a 4-week Safety Follow-Up period.
Interventions
- Drug HB0043
Low dose - Drug HB0043
Medium dose - Drug HB0043
High dose
Primary outcome measures
- Safety and Tolerability of HB0043 in Patients with Moderate to Severe HS [Time frame: From randomization to end of study, assessed up to 24 weeks.]
Secondary outcome measures (12)
- Percentage of participants achieving HiSCR [Time frame: Week 16 and 24]
- Change From Baseline in Inflammatory Lesion (Abscesses and Inflammatory Nodules) Count [Time frame: Week 16 and 24]
- Change From Baseline in the number of lesions [Time frame: Week 16 and 24]
- Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in PGA-NRS [Time frame: Week 16 and 24]
- Percentage of participants achieving HiSCR75 [Time frame: Week 16 and 24]
- Change in absolute score from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) [Time frame: Week 16 and 24]
- Serum HB0043 concentrations throughout the study [Time frame: From randomization to end of study, assessed up to 24 weeks.]
- Incidence of anti-HB0043 antibody positive response throughout the study [Time frame: From randomization to end of study, assessed up to 24 weeks.]
- Percentage of participants achieving HiSCR90 [Time frame: Week 16 and 24]
- Percentage of participants achieving HiSCR100 [Time frame: Week 16 and 24]
- Change of the most severe Patient's Global Assessment of Skin Pain (PGA Skin Pain) within the past 24 hours [Time frame: Week 16 and 24]
- Dermatology Life Quality Index (DLQI) [Time frame: Week 16 and 24]
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:
- HS lesions in at least 2 distinct anatomic area;
- One of the HS lesions must be Hurley Stage II or Hurley Stage III;
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Dermatology Hospital affiliated to Shandong First Medical University — Jinan
Identifiers
NCT: NCT06895499 · HB0043-HS-0-01