Hidradenitis SuppurativaPhase 2NCT07151937
A Study of LAD191 in Adults With Hidradenitis Suppurativa
A Phase 2 study testing LAD191 and Adalimumab in people with Hidradenitis Suppurativa, run by Almirall, S.A. at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- LAD191 and Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 5 Nov 2025to 25 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged greater than or equal to (>=) 18 to less than or equal to (<=) 65 years.
- A diagnosis of moderate-to-severe HS defined as a total of >= 5 inflammatory lesions (i.e., number of abscesses plus number of inflammatory nodules) at both the Screening and Baseline/Day 1 visits, with signs and symptoms of HS for at least 6 months.
- HS lesions present in at least 2 distinct anatomic areas (e.g., left and right axilla), one of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline/Day 1 visits.
- History of inadequate response, intolerance, or contraindication to a course of a systemic antibiotics for treatment of HS at the screening visit.
- Regular use of over-the-counter topical antiseptics on HS lesions and agrees to regular use, throughout the entirety of the study.
- Participants who are women of child-bearing potential (WOBCP) and male participants must agree to the requirements for the avoidance of pregnancy and exposure of the participant's partner to LAD191 during the study.
Who cannot join
- HS with >20 draining tunnels at the Screening or Baseline/Day 1 visit.
- Ongoing medical conditions requiring systemic immunosuppressive/immunomodulating treatments during the study.
- Known hypersensitivity to LAD191 or any of its excipients.
- Known hypersensitivity to adalimumab or biosimilar or any of its excipients or meeting any warning or contraindication to adalimumab treatment as per the approved product information, and as per the Investigator's judgment.
- Hypersensitivity or systemic reaction to a prior biologic (antibody-based) therapy, regardless of indication, that was clinically significant, as per the Investigator's judgment.
- Prior treatment with LAD191.
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- Live or attenuated vaccinations 4 weeks prior to Baseline/Day 1 or is planning to receive any such vaccine during the study.
- Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
- Intention to use any concomitant medication or therapy that is not permitted by this protocol or failure to meet the required washout period for a particular prohibited medication prior to Baseline/Day 1.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital de Manises
Manises, 46940
Antonio Jaime Martorell Calatayud, 0034636496315, martorelldermatologia@gmail.com
About this study
Official title: A Seamless Phase 2a/2b, Randomized, Double-Blind, Placebo- and Active-Controlled, Multiple-Arm, Multiple-Stage, Adaptive Study Evaluating the Efficacy and Safety of LAD191 in Adults With Moderate-to-Severe Hidradenitis Suppurativa
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.
Read the detailed description
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.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- LAD191, Placebo, Adalimumab
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAD191Drug
LAD191 subcutaneous injection.
PlaceboOther
LAD191 Placebo subcutaneous injection.
AdalimumabDrug
Adalimumab subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| LAD191 Dose A | Experimental | 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. Receives: Drug: LAD191 |
| LAD191 Dose B | Experimental | 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. Receives: Drug: LAD191 |
| LAD191 Dose C | Experimental | 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. Receives: Drug: LAD191 |
| Placebo | Placebo comparator | 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. Receives: Drug: LAD191; Other: Placebo |
| Adalimumab | Active comparator | 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. Receives: Drug: LAD191; Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Week 16
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start5 Nov 2025
- Primary completion25 May 2027 (estimated)
- Study completion25 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Almirall, S.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double-blind, multiple-arm, adaptive treatment-selection designed study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Almirall, S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151937
- Sponsor's protocol ID
- M-27134-10
- Other IDs
- 2025-521293-34-00, 2025
- Status last verified
- Apr 2026
- First submitted
- 2 Sep 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Seamless Phase 2a/2b, Randomized, Double-Blind, Placebo- and Active-Controlled, Multiple-Arm, Multiple-Stage, Adaptive Study Evaluating the Efficacy and Safety of LAD191 in Adults With Moderate-to-Severe Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT07151937
- Acronym / sponsor ID
- M-27134-10
- Conditions
- Hidradenitis Suppurativa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- 25 May 2027 (estimated)
- Study completion
- 25 Nov 2027 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- A double-blind, multiple-arm, adaptive treatment-selection designed study.
| Arm | Type | Receives |
|---|---|---|
| LAD191 Dose A | Experimental | Drug: LAD191Participants 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. |
| LAD191 Dose B | Experimental | Drug: LAD191Participants 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. |
| LAD191 Dose C | Experimental | Drug: LAD191Participants 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. |
| Placebo | Placebo comparator | Drug: LAD191, Other: PlaceboParticipants 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. |
| Adalimumab | Active comparator | Drug: LAD191, Drug: AdalimumabParticipants will receive adalimumab SC injection during Treatment Period 1 and will begin treatment with the highest available dose of LAD191 during Treatment Period 2. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged greater than or equal to (>=) 18 to less than or equal to (<=) 65 years.
- A diagnosis of moderate-to-severe HS defined as a total of >= 5 inflammatory lesions (i.e., number of abscesses plus number of inflammatory nodules) at both the Screening and Baseline/Day 1 visits, with signs and symptoms of HS for at least 6 months.
- HS lesions present in at least 2 distinct anatomic areas (e.g., left and right axilla), one of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline/Day 1 visits.
- History of inadequate response, intolerance, or contraindication to a course of a systemic antibiotics for treatment of HS at the screening visit.
- Regular use of over-the-counter topical antiseptics on HS lesions and agrees to regular use, throughout the entirety of the study.
Key exclusion criteria (9 listed)
- HS with >20 draining tunnels at the Screening or Baseline/Day 1 visit.
- Ongoing medical conditions requiring systemic immunosuppressive/immunomodulating treatments during the study.
- Known hypersensitivity to LAD191 or any of its excipients.
- Known hypersensitivity to adalimumab or biosimilar or any of its excipients or meeting any warning or contraindication to adalimumab treatment as per the approved product information, and as per the Investigator's judgment.
- Hypersensitivity or systemic reaction to a prior biologic (antibody-based) therapy, regardless of indication, that was clinically significant, as per the Investigator's judgment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAD191LAD191 subcutaneous injection. | Drug | Adalimumab, LAD191 Dose A, LAD191 Dose B, LAD191 Dose C, Placebo |
| PlaceboLAD191 Placebo subcutaneous injection. | Other | Placebo |
| AdalimumabAdalimumab subcutaneous injection. | Drug | Adalimumab |
Primary outcome
Proportion of Participants Achieving 50 Percent (%) Reduction from Baseline in Hidradenitis Suppurativa Clinical Response (HiSCR-50)
Time frame: At Week 16
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.
5 secondary outcomes
Proportion of Participants Achieving 75% Reduction from Baseline in HiSCR-75 at Week 16
Time frame: At Week 16
Proportion of Participants Achieving 90% Reduction from Baseline in HiSCR-90 at Week 16
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
Time frame: At Week 16
Change from Baseline in Skin Pain Numerical Rating Scale (NRS) at Week 16
Time frame: At Week 16
Change from Baseline in Hidradenitis Suppurativa Quality of Life (HiSQOL) at Week 16
Time frame: At Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
Almirall, S.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LAD191 and Adalimumab in people with Hidradenitis Suppurativa, run by Almirall, S.A. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victor Castellano (+34932746671, gco@almirall.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Achieving 50 Percent (%) Reduction from Baseline in Hidradenitis Suppurativa Clinical Response (HiSCR-50) (time frame: At Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.