Health TrialsbyHealthPanel

Safety and Efficacy of Soquelitinib in Adults With Hidradenitis Suppurativa

ConditionHidradenitis Suppurativa (HS)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCorvus Pharmaceuticals, Inc.

About this trial

Safety and Efficacy of Soquelitinib in Adults with Hidradenitis Suppurativa

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult male or female, ≥18 years of age at the time of signing the informed consent form (ICF)

A diagnosis of moderate-to-severe HS for at least 1 year prior to the Screening visit from review of medical history and/or participant interview.

A total AN count of ≥5 inflammatory lesions (ie, number of abscesses plus number of inflammatory nodules) including at least 2 palpable inflammatory nodules at both the Screening and Baseline (Day 1) visits.

Draining tunnel count of ≤20 at the Screening or Baseline (Day 1) visit.

Disqualifiers

Currently experiencing, or previous history of, other concomitant skin conditions (eg, psoriasis, cutaneous lupus, previous burns, or extensive tattoos) that would interfere with evaluations of the effect of study intervention on HS.

Other active skin diseases or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 30 days of the Baseline visit (Day 1) or that could interfere with the appropriate assessment of HS lesions.

Known immunodeficiency syndrome, history of an invasive infection (eg, sepsis, severe pneumonia, osteomyelitis), or active non-skin-related infection requiring systemic anti-infective treatment within 30 days of Baseline (Day 1).

History of immunosuppression not related to medication (such as common variable hypogammaglobulinemia), history of clinically significant medical conditions (such as anemia, neutropenia, thrombocytopenia, abnormal renal function, or abnormal liver function), planned surgical procedures, or any other reason which in the opinion of the investigator or sponsor would interfere with the participant's participation in this study, would make the participant an unsuitable candidate to receive study intervention, or would put the participant at risk by participating in the study; or permanently wheelchair-bound or bedridden or very poor functional status which prevents the ability to perform self-care.

Trial design

Design model

Single group

Treatments tested in this trial

  • Soquelitinib

    Drug

    Tablets

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Single-ArmOther 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of adverse events, changes in laboratory values, vital signs, and ECGs

Incidence, nature, and severity of treatment-emergent adverse events of soquelitinib, including changes in laboratory values, vital signs, and ECGs

Time frame
up to 30 days after last intervention administration

Secondary outcomes

1

1) percentage of participants achieving HiSCR50 2) percentage of participants achieving HiSCR75 3) percentage of participants achieving HiSCR90

HiSCR is a validated clinical endpoint used to assess the inflammatory signs and symptoms of HS. HiSCR evaluation is based in count of active HS lesions including abscesses, inflammatory nodules and draining tunnels (fistulas). The sum of abscesses and inflammatory nodules constitutes the total AN count.

Time frame
Week 12
2

Efficacy as measured by Hidradenitis Suppurativa Severity Score System (IHS4)

IHS4 captures the inflammatory burden of draining tunnels, inflammatory nodules and abscesses. Different weights are assigned to each lesion type: 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 total IHS4 score.

Time frame
Week 12
3

Efficacy as measured by change and percentage change in lesion count

Lesion count includes abscess count, inflammatory nodule count, abscess and inflammatory nodule \[AN\] count, draining tunnel count

Time frame
Week 12
4

1) at least 30% reduction and at least 1-pt reduction and 2) at least 3-pt reduction from Baseline in the weekly average of daily HS-Skin Pain NRS

The Skin Pain-NRS is used to assess participants self-reported severity of worst skin pain each day. The NRS is an 11-point scale (0 to 10), with 0 indicating "no pain" and 10 indicating the "worst pain imaginable" in a 24-hour recall period.

Time frame
Week 12

Other outcomes

Sponsors and contacts

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

Corvus Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
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