A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Ichthyosis

Vanda Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Ichthyosis

Treatments: Biological: placebo; Drug: Imsidolimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04697056

ANB019-206

2020-003476-41 (EudraCT Number)

Details and patient eligibility

About

Efficacy and Safety of imsidolimab in Participants with Ichthyosis

Full description

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of imsidolimab compared with placebo in adolescent and adult participants with ichthyosis. This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immune response to imsidolimab in participants with ichthyosis.

Enrollment: 5 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Ichthyosis
• IASI total score ≥ 18, erythema score ≥ 2
• Participant has been using emollient daily for at least 1 week prior to Day 1 and agrees to continue using that same emollient daily at the same frequency throughout the study

Exclusion criteria

• A participant with ichthyosis vulgaris, X-linked ichthyosis, or lamellar ichthyosis will be excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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5 participants in 2 patient groups, including a placebo group

Imsidolimab

Experimental group

Description:

Participants received a starting dose of 400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.

Treatment:

Drug: Imsidolimab

Placebo

Placebo Comparator group

Description:

Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.

Treatment:

Biological: placebo