A Phase 2 interventional study of LAD191 and Placebo in Hidradenitis Suppurativa, sponsored by Almirall, S.A.. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by Almirall, S.A. · Phase 2, Interventional, and Treatment
The main purpose of this study is to assess the efficacy of multiple dosing regimens of LAD191 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.
The purpose of this study is to assess the multiple dosing regimens of LAD191 compared to placebo in participants with moderate-to-severe Hidradenitis Suppurativa (HS). The study has a prospectively defined adaptive design that will utilize interim data for futility evaluation.
The study includes up to 4 weeks screening period 16-week double-blind, placebo-controlled period (Treatment period 1), 16-weeks LAD191 double-blind period (Treatment period 2), and 12-week safety follow-up.
The study participants will be randomized to one of the following treatment arms: LAD191 dose A, LAD191 dose B; LAD191 dose C, Adalimumab or Placebo.
284 studies on the registry are indexed under Hidradenitis Suppurativa; 87 are open to participants now.
This study's planned enrollment of 200 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.
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.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
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.
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.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive dose A LAD191 subcutaneous (SC) injection during both Treatment Period 1 and Treatment Period 2, unless if Dose A is eliminated after interim analysis, participants will receive the highest available dose of LAD191 during Treatment Period 2.
Drug: LAD191
Participants will receive dose B LAD191 SC injection during both Treatment Period 1 and Treatment Period 2, unless if Dose B is eliminated after interim analysis, participants will receive the highest available dose of LAD191 during Treatment Period 2.
Drug: LAD191
Participants will receive dose C LAD191 SC injection during both Treatment Period 1 and Treatment Period 2, unless if Dose C is eliminated after interim analysis, participants will receive the highest available dose of LAD191 during Treatment Period 2.
Drug: LAD191
Participants will receive matching LAD191 placebo SC injection during Treatment Period 1 and will begin treatment with the highest available dose of LAD191 during Treatment Period 2.
Drug: LAD191 · Other: Placebo
Participants will receive adalimumab SC injection during Treatment Period 1 and will begin treatment with the highest available dose of LAD191 during Treatment Period 2.
Drug: LAD191 · Drug: Adalimumab
LAD191 subcutaneous injection.
LAD191 Placebo subcutaneous injection.
Adalimumab subcutaneous injection.
Proportion of Participants Achieving 50 Percent (%) Reduction from Baseline in Hidradenitis Suppurativa Clinical Response (HiSCR-50)
HiSCR-50 is defined as ≥50% reduction in total AN count, with no increase in abscess count, and no increase in draining fistula count relative to baseline.
Time frame: At Week 16
Proportion of Participants Achieving 75% Reduction from Baseline in HiSCR-75 at Week 16
HiSCR-75 is defined as ≥75% reduction in total AN count, with no increase in abscess count, and no increase in draining fistula count relative to baseline.
Time frame: At Week 16
Proportion of Participants Achieving 90% Reduction from Baseline in HiSCR-90 at Week 16
HiSCR-90 is defined as 90% reduction in total AN count, with no increase in abscess count, and no increase in draining fistula count relative to baseline.
Time frame: At Week 16
Proportion of Participants Achieving 55% Reduction from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4-55) at Week 16
The IHS4 is determined by counting nodules, abscesses, and draining tunnels (fistulae/sinuses). IHS4 (points) = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + \[number of draining tunnels (fistulae/sinuses) multiplied by 4\]. A score of 3 or lower indicates a mild stage of hidradenitis suppurativa, a score of 4-10 indicates a moderate stage, and a score of 11 or higher indicates a severe stage of the disease. IHS4-55, is a dichotomous IHS4 variable based on a ≥55% reduction of the total score.
Time frame: At Week 16
Change from Baseline in Skin Pain Numerical Rating Scale (NRS) at Week 16
Skin Pain NRS is an 11-point scale in which patients are asked to rate their skin pain over the prior 24 hours, where 0 is no skin pain and 10 is pain as bad.
Time frame: At Week 16
Change from Baseline in Hidradenitis Suppurativa Quality of Life (HiSQOL) at Week 16
The HiSQOL was specifically developed for use in clinical trials to assess Quality of Life (QoL) and comprises a 17-item questionnaire grouped into 3 sub-scales covering symptoms, psychosocial, and activity-adaptation aspects, with a recall period of seven days. Each item is structured as a Likert-type scale with five or seven response levels and, for all items, the score ranges from 0 (not at all) to 4 (extremely). 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 quality of life.
Time frame: At Week 16
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.