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| Name | Class |
|---|---|
| Dermatology Hospital affiliated to Shandong First Medical University | UNKNOWN |
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The purpose of this study is to assess efficacy safety and tolerability of HB0043 in adult patients with moderate to severe HS.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HB0043 | Drug | Low dose |
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| HB0043 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From randomization to end of study, assessed up to 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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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:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Hospital affiliated to Shandong First Medical University | Recruiting | Jinan | Shandong | China |
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| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Drug |
Medium dose |
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| HB0043 | Drug | High dose |
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| 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. | 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. | 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. | 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 | 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. | Week 16 and 24 |
| Serum HB0043 concentrations throughout the study | From randomization to end of study, assessed up to 24 weeks. |
| Incidence of anti-HB0043 antibody positive response throughout the study | 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 | 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 | 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 | 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. | Week 16 and 24 |
| hange of Hidradenitis Suppurativa Area and Severity Index Revised (HASI-R) | Change from baseline in HASI-R | Week 16 and 24 |
| Change of HIDRA score | Change from baseline in HIDRA score | Week 16 and 24 |
| Long-term efficacy of sonelokimab: Hidradenitis Suppurativa Quality of Life (HiSQOL) | Change from baseline in HiSQOL total score | Week 16 and 24 |
| Change of Numerical Rating Scale (NRS) | Percentage of participants achieving a ≥3-unit reduction from baseline in the NRS | Week 16 and 24 |
| Pharmacodynamic indicators include but are not limited to IL-17 and IL-36. | From randomization to end of study, assessed up to 24 weeks. |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |