Hidradenitis SuppurativaPhase 1/2HB0043-HS-0-01NCT06895499
Efficacy, Safety, and Tolerability of HB0043 in Hidradenitis Suppurativa Patients.
A Phase 1/2 study testing HB0043 in people with Hidradenitis Suppurativa, run by Shanghai Huaota Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to assess efficacy safety and tolerability of HB0043 in adult patients with moderate to severe HS. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- HB0043
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 19 Mar 2025to 30 Mar 2026
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Dermatology Hospital affiliated to Shandong First Medical University
Jinan, Shandong
Wu, +86-15040367023, xueqiong.wu@huaota.com
About this study
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).
The purpose of this study is to assess efficacy safety and tolerability of HB0043 in adult patients with moderate to severe HS.
Read the 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.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- HB0043
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB0043Drug
Low dose
HB0043Drug
Medium dose
HB0043Drug
High dose
| Study group | Role | What they receive |
|---|---|---|
| HB0043: Low dose | Experimental | Participants assigned to arm 1 will receive a low dose of HB0043 via intravenous infusion every two weeks starting from week 0. The dose of HB0043 will adjusted to high dose at weeks 10, and the frequency remains Q2W. The frequency will adjusted to Q4W from weeks16, the last administration is weeks 20. Receives: Drug: HB0043 |
| HB0043: Medium dose | Experimental | Participants assigned to Arm 2 will receive a medium dose of HB0043 via intravenous infusion every two weeks, commencing at week 0, and then at weeks 16 and 20. Receives: Drug: HB0043 |
| HB0043: High dose | Experimental | Participants assigned to Arm 3 will receive a high dose of HB0043 via intravenous infusion every two weeks, commencing at week 0, and then at weeks 16 and 20. Receives: Drug: HB0043 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of HB0043 in Patients with Moderate to Severe HS
The incidence rate, characteristics, relevance, and severity of treatment-emergent adverse events (TEAEs) experienced by subjects during the treatment period.
Measured: From randomization to end of study, assessed up to 24 weeks.
Secondary outcomes (17)
Percentage of participants achieving HiSCR
Percentage of participants achieving HiSCR at Week 12 was reported. For this score participants were defined as achievers or non-achievers. The positive HiSCR score was defined as a greater than or equal to (>=) 50% reduction in inflammatory lesion AN count (sum of abscesses and inflammatory nodules), and no increase in abscesses or draining fistulas in hidradenitis suppurativa compared with the lesions counted on visit 1 (baseline).
Measured: Week 16 and 24
Change From Baseline in Inflammatory Lesion (Abscesses and Inflammatory Nodules) Count
The sum of abscesses and inflammatory nodules was measured for each participant to assess change in inflammatory lesion counts.
Measured: Week 16 and 24
Change From Baseline in the number of lesions
The number of lesions refers to the total sum of abscesses, iInflammatory nodules, and draining fistulas count.
Measured: Week 16 and 24
Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in PGA-NRS
PGA-NRS is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain), ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the PGA-NRS.
Measured: Week 16 and 24
Percentage of participants achieving HiSCR75
HiSCR75 is defined as at least a 75% reduction from Baseline in the total abscess and inflammatory nodule [AN] count, with no increase from Baseline in abscess or draining tunnel count
Measured: Week 16 and 24
Change in absolute score from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4)
Change from baseline in IHS4. IHS4 score is calculated by the number of nodules (multiplied by 1) + the number of abscesses (multiplied by 2) + the number of draining tunnels (multiplied by 4).
A total score of 3 or less signifies mild, 4-10 signifies moderate and 11 or higher signifies severe disease.
Measured: Week 16 and 24
Serum HB0043 concentrations throughout the study
Measured: From randomization to end of study, assessed up to 24 weeks.
Incidence of anti-HB0043 antibody positive response throughout the study
Measured: From randomization to end of study, assessed up to 24 weeks.
Percentage of participants achieving HiSCR90
HiSCR90 is defined as at least a 90% reduction from Baseline in the total abscess and inflammatory nodule [AN] count, with no increase from Baseline in abscess or draining tunnel count
Measured: Week 16 and 24
Percentage of participants achieving HiSCR100
HiSCR100 is defined as at least a 100% reduction from Baseline in the total abscess and inflammatory nodule [AN] count, with no increase from Baseline in abscess or draining tunnel count
Measured: Week 16 and 24
Change of the most severe Patient's Global Assessment of Skin Pain (PGA Skin Pain) within the past 24 hours
The change from baseline in the most severe PGA Skin Pain (NRS score) within the past 24 hours
Measured: Week 16 and 24
Dermatology Life Quality Index (DLQI)
Percentage of participants achieving a DLQI total reduction of ≥4 minimal clinically important difference among participants with a baseline DLQI ≥4. DLQI produces a numeric score that can range from 0 to 30. A higher score indicates greater health related quality of life impairment.
Measured: Week 16 and 24
hange of Hidradenitis Suppurativa Area and Severity Index Revised (HASI-R)
Change from baseline in HASI-R
Measured: Week 16 and 24
Change of HIDRA score
Change from baseline in HIDRA score
Measured: Week 16 and 24
Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Quality of Life (HiSQOL)
Change from baseline in HiSQOL total score
Measured: Week 16 and 24
Change of Numerical Rating Scale (NRS)
Percentage of participants achieving a ≥3-unit reduction from baseline in the NRS
Measured: Week 16 and 24
Pharmacodynamic indicators include but are not limited to IL-17 and IL-36.
Measured: From randomization to end of study, assessed up to 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start19 Mar 2025
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Huaota Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dermatology Hospital affiliated to Shandong First Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895499
- Sponsor's protocol ID
- HB0043-HS-0-01
- Acronym
- HB0043-HS-0-01
- Status last verified
- Jan 2026
- First submitted
- 7 Mar 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No