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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
Are there results?
Not yet: the study is under way

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

  • Dermatology Hospital affiliated to Shandong First Medical University

    Jinan, Shandong

    Wu, +86-15040367023, xueqiong.wu@huaota.com

    Recruiting

Other trials in China

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.

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 groups in NCT06895499
Study groupRoleWhat they receive
HB0043: Low doseExperimentalParticipants 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 doseExperimentalParticipants 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 doseExperimentalParticipants 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.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Serum HB0043 concentrations throughout the study

    Measured: From randomization to end of study, assessed up to 24 weeks.

  8. Incidence of anti-HB0043 antibody positive response throughout the study

    Measured: From randomization to end of study, assessed up to 24 weeks.

  9. 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

  10. 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

  11. 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

  12. 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

  13. hange of Hidradenitis Suppurativa Area and Severity Index Revised (HASI-R)

    Change from baseline in HASI-R

    Measured: Week 16 and 24

  14. Change of HIDRA score

    Change from baseline in HIDRA score

    Measured: Week 16 and 24

  15. Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Quality of Life (HiSQOL)

    Change from baseline in HiSQOL total score

    Measured: Week 16 and 24

  16. Change of Numerical Rating Scale (NRS)

    Percentage of participants achieving a ≥3-unit reduction from baseline in the NRS

    Measured: Week 16 and 24

  17. 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.

  1. First posted26 Mar 2025
  2. Study start19 Mar 2025
  3. Primary completion30 Jan 2026 (estimated)
  4. Study completion30 Mar 2026 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HB0043 in people with Hidradenitis Suppurativa, run by Shanghai Huaota Biopharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06895499.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.

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