Clinical trial NCT04697056: A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Ichthyosis
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ANB019 in the Treatment of Subjects With Ichthyosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ichthyosis
Keywords: IL-36 Receptor
Interleukin 36
Imsidolimab
Lead sponsor: AnaptysBio, Inc.
Sponsor class: INDUSTRY
First posted: 2021-01-06
Enrollment: 5
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy and Safety of imsidolimab in Participants with Ichthyosis

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Ichthyosis Area Severity Index (IASI) Total Score at Week 16
timeFrame: Baseline and Week 16
Secondary outcomes:
measure: Percent Change From Baseline in IASI Total Score at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants Achieving an Improvement of 50% From Baseline in IASI (IASI50) at Week 16
timeFrame: Week 16
measure: Change From Baseline in IASI-E Scores at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in IASI-S Scores at Week 16
timeFrame: Baseline and Week 16
measure: Percent Change From Baseline in IASI-E Scores at Week 16
timeFrame: Baseline and Week 16
measure: Percent Change From Baseline in IASI-S Scores at Week 16
timeFrame: Baseline and Week 16
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: From first dose up to study termination (maximum up to 9.4 weeks)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Site 106
state: California
city: New Haven
country: United States
facility: Site 104
state: Connecticut
city: Miami
country: United States
facility: Site 112
state: Florida
city: Chicago
country: United States
facility: Site 101
state: Illinois
city: Columbus
country: United States
facility: Site 102
state: Ohio
city: San Antonio
country: United States
facility: Site 107
state: Texas
city: Salt Lake City
country: United States
facility: Site 105
state: Utah
Study officials:
affiliation: AnaptysBio, Inc.
name: Bruce Randazzo, MD
role: STUDY_DIRECTOR
References: