A Phase 2 interventional study of LAD328 and Placebo in Hidradenitis Suppurativa, sponsored by Almirall, S.A.. Recruiting at 1 site in Poland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Almirall, S.A. · Phase 2, Interventional, and Treatment
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
284 studies on the registry are indexed under Hidradenitis Suppurativa; 87 are open to participants now.
This study's planned enrollment of 50 is above the median of 45 across 199 interventional studies indexed under Hidradenitis Suppurativa.
Browse Hidradenitis Suppurativa studies →Almirall, S.A. is the lead sponsor of 66 studies on the registry; 9 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive LAD328 Dose A, intravenous (IV) infusion.
Drug: LAD328
Participants will receive placebo diluent solution for IV infusion.
Other: Placebo
LAD328 administered intravenously.
Placebo administered intravenously.
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.
Time frame: At Week 12
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.
Time frame: At Week 12
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At Week 12
Plan to share: No
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