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A Proof-of-Concept Study of LAD328 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 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female between 18 and 65 years old inclusive.

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 visits, with a clinical history 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 visits.

History of inadequate response, or intolerance or contraindication, to a course of a systemic antibiotics for treatment of HS at the Screening visit.

Disqualifiers

HS with >20 draining tunnels either at the Screening or Baseline visits.

Ongoing medical conditions (e.g., inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus and sarcoidosis) requiring systemic immunosuppressive/immunomodulating treatments (e.g., methotrexate, ciclosporin, corticosteroids, cytokine-targeted therapy and JAK inhibitors) during the trial.

Known or suspected hypersensitivity to trial product or any of its excipients.

Hypersensitivity or systemic reaction to a prior biologic (antibody-based) therapy (regardless of indication), that was clinically significant, as per judgment of Investigator.

Trial design

Design model

Parallel

Treatments tested in this trial

  • LAD328

    Drug

    LAD328 administered intravenously.

  • Placebo

    Other intervention

    Placebo administered intravenously.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: LAD328Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

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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