Study to Evaluate Soquelitinib in Participants With Moderate to Severe AD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCorvus Pharmaceuticals, Inc.
About this trial
The main purpose of this study is to see how well different doses of soquelitinib work in participants with atopic dermatitis (AD) as compared to a placebo (pill with no medicine in it). To check this, the study doctors will examine participants' skin regularly to track how their AD changes during the study.
The study doctors will see how safe soquelitinib is by tracking side effects among participants. They will also check "tolerability," which means how well the participants can handle soquelitinib and whether any potential side effects are manageable for them.
To understand how well soquelitinib works, it will be compared with a placebo. Placebo is a substance that looks like soquelitinib but contains no active medicine in it.
Participants will:
* Take study treatment (soquelitinib or placebo) every day for 12 weeks * Visit the clinic for check-ups and tests every week for the first 2 weeks then every 2 weeks during the treatment period, and then return for follow-up visits 30, 60, and 90 days after the last dose of study treatment
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult male or female, ≥18 years of age, as applicable according to local legislation, at Screening.
Diagnosis of AD with onset of symptoms at least 1 year prior to the Screening visit.
EASI ≥16
Body surface area ≥10%
Disqualifiers
Other concomitant skin conditions that would interfere with evaluations of the effect of study medication on AD.
Other active skin diseases or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 30 days of the Baseline visit or that could interfere with the appropriate assessment of AD lesions.
Known immunodeficiency syndrome, history of an invasive infection or active non skin-related infection requiring systemic anti-infective treatment within 30 days of Baseline.
History of immunosuppression not related to medication, history of clinically significant medical conditions, or any other reason which in the opinion of the investigator would interfere with the participant's participation in this study.
Trial design
Design model
Parallel
Treatments tested in this trial
Soquelitinib
DrugSoquelitinib tablets
Placebo
DrugSoquelitinib matching placebo tablets
Treatment groups
200 Participants
are divided into 4 treatment groupsGroup A: Cohort 1 - Soquelitinib 200 mg once dailyExperimental treatment 2 interventions
Group B: Cohort 2 - Soquelitinib 200 mg twice dailyExperimental treatment 2 interventions
Group C: Cohort 3 - Soquelitinib 400 mg once dailyExperimental treatment 2 interventions
Group D: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percent change from baseline in Eczema Area and Severity Index (EASI) score at Week 12
EASI is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head and neck, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Time frame
Baseline through Week 12Secondary outcomes
1
Response of achieving 75% reduction in EASI (EASI75) score at Week 12
EASI is used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head and neck, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Time frame
Baseline through Week 122
Response of achieving validated Investigator Global Assessment (vIGA) score of 0 or 1 with reduction from Baseline of ≥2 points at Week 12
vIGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema, induration/papulation, lichenification and oozing/crusting, and takes extent of disease into account. Therapeutic response is a IGA score of 0 (clear) or 1 (almost clear).
Time frame
Baseline through Week 123
Response of achieving ≥4-point decrease in Peak Pruritus-Numerical Rating Scale (PP-NRS) score at Week 12
PP-NRS is a validated, single-item, patient-reported outcome of itch severity measured by an 11-point scale for worst itch over the last 24 hours
Time frame
Baseline through Week 124
Safety and tolerability
Incidence, nature, and severity of treatment-emergent adverse events of soquelitinib compared with placebo, including changes in laboratory values, vital signs, and electrocardiograms (ECGs)
Time frame
Up to 30 days after last intervention administrationSponsors and contacts
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Source ClinicalTrials.gov