Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
Healthy Volunteers
NCT06895499

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

Led by Shanghai Huaota Biopharmaceutical Co., Ltd. · Updated on 2026-01-07

15

Participants Needed

1

Research Sites

53 weeks

Total Duration

On this page

Sponsors

S

Shanghai Huaota Biopharmaceutical Co., Ltd.

Lead Sponsor

D

Dermatology Hospital affiliated to Shandong First Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to assess efficacy safety and tolerability of HB0043 in adult patients with moderate to severe HS.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Understand the study and provide written informed consent
  • Male or female, age 18 years or older
  • Diagnosed with hidradenitis suppurativa for at least 6 months before screening
  • Moderate to severe hidradenitis suppurativa with lesions in at least 2 distinct body areas
  • At least one lesion at Hurley Stage II or III
  • Total abscess and inflammatory nodule count of 3 or more
  • If of childbearing potential, agree to use safe contraceptive methods throughout the study and for 6 months after
Not Eligible

You will not qualify if you...

  • Known allergy to HB0043 or its ingredients
  • Having 20 or more draining fistulas at screening
  • Other active autoimmune diseases besides hidradenitis suppurativa (e.g., psoriasis, rheumatoid arthritis)
  • Any other active skin disease interfering with hidradenitis suppurativa assessment
  • History of lymphoproliferative disorders or cancer within 5 years (except certain treated skin or breast cancers)
  • History of recurrent or recent serious infections
  • Active tuberculosis or being treated for latent tuberculosis
  • Evidence of hepatitis B, hepatitis C, or HIV infection
  • Pregnant or breastfeeding women
  • Any condition that the investigator believes makes participation unsuitable

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Dermatology Hospital affiliated to Shandong First Medical University

Jinan, Shandong, China

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

3

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