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A Study of LAD191 in Adults With Hidradenitis Suppurativa

ConditionHidradenitis Suppurativa
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAlmirall, S.A.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • LAD191

    Drug

    LAD191 subcutaneous injection.

  • Placebo

    Other intervention

    LAD191 Placebo subcutaneous injection.

  • Adalimumab

    Drug

    Adalimumab subcutaneous injection.

Treatment groups

200 Participants
are divided into 5 treatment groups
Group A: LAD191 Dose AExperimental treatment 1 intervention
Group B: LAD191 Dose BExperimental treatment 1 intervention
Group C: LAD191 Dose CExperimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 2 interventions
Group E: AdalimumabActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Almirall, S.A.

Lead sponsor

Source ClinicalTrials.gov
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