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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521865-29-00 | EU Trial (CTIS) Number |
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The main purpose of this study is to evaluate the effect of LAD328 compared to placebo in participants with moderate-to-severe Hidradenitis Suppurativa (HS), and to access the safety, tolerability, pharmacokinetic and immunogenicity in participants with moderate-to-severe HS.
Hidradenitis suppurativa (HS) is a chronic skin disease of unclear etiology that affects approximately 1% of the general population.
The purpose of this study is to assess the efficacy of LAD328 compared to placebo in participants with moderate-to-severe HS.
The study participants will be randomized to one of the following treatment arms: LAD328 or Placebo.
The study includes up to 4 weeks screening period 12-week double-blind, placebo-controlled period and 8-week safety follow-up.
The total duration of study participation will be up to 20 weeks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAD328 | Experimental | Participants will receive LAD328 Dose A, intravenous (IV) infusion. |
|
| Placebo | Placebo Comparator | Participants will receive placebo diluent solution for IV infusion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAD328 | Drug | LAD328 administered intravenously. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Achieving 55 Percent (%) Reduction from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4-55) | IHS4 assigns different weights to different lesion types: inflammatory nodules (1 point), abscesses (2 points), and draining tunnels (4 points). The number of each lesion type is multiplied by its respective weight and the three obtained values are then summed to obtain the IHS4 total score. IHS4-55 is a dichotomous IHS4 variable based on a >=55% reduction of the total score. | At Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Achieving 50% Reduction from Baseline in Hidradenitis Suppurativa Clinical Response (HiSCR50) | The HiSCR is defined as >=50% reduction in the abscess and inflammatory nodule count (AN count) with no increase in abscess count and no increase in draining fistula count relative to baseline. | At Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Estrella Garcia | Contact | +34620985953 | gco@almirall.com | |
| Andrea Pejenaute | Contact | +34 697189586 | apejenaute@almirall.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Almirall, S.A. | Study Director |
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| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| D016575 | Hidradenitis |
| D012871 | Skin Diseases |
| D007239 | Infections |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D012874 | Skin Diseases, Infectious |
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| Other |
Placebo administered intravenously. |
|
| Proportion of Participants Achieving 75% Reduction from Baseline in HiSCR-75 |
The HiSCR is defined as >=75% reduction in the abscess and inflammatory nodule count (AN count) with no increase in abscess count and no increase in draining fistula count relative to baseline. |
| At Week 12 |
| Proportion of Participants Achieving 90% Reduction from Baseline in HiSCR-90 | The HiSCR is defined as >=90% reduction in the abscess and inflammatory nodule count (AN count) with no increase in abscess count and no increase in draining fistula count relative to baseline. | At Week 12 |
| Change from Baseline in Skin Pain Numerical Rating Scale (NRS) | Skin Pain NRS is an 11-point scale in which participants are asked to rate their skin pain over the prior 24 hours, where 0 is no skin pain and 10 is pain as bad as you can imagine. | At Week 12 |
| Change from Baseline in Hidradenitis Suppurativa Quality of Life (HiSQOL) | HiSQOL was specifically developed for use in clinical trials and comprises a 17-item questionnaire grouped into 3 sub-scales covering symptoms, psychosocial, and activity-adaptation aspects, with a recall period of 7 days. Individual item scores are summed and a total score ranging from 0 to 68 is calculated, where the higher the score the more impact HS has on QoL. | At Week 12 |
| D013492 | Suppuration |
| D017437 | Skin and Connective Tissue Diseases |
| D013543 | Sweat Gland Diseases |