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

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ANB019 in the Treatment of Subjects With Ichthyosis

Efficacy and Safety of imsidolimab in Participants with Ichthyosis

Study Overview

• Status: Terminated
• Conditions: Ichthyosis
• Intervention / Treatment: Drug: Imsidolimab; Biological: placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Site 106
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • SITE 104
  • Florida
    • Miami, Florida, United States, 33125
      • Site 112
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Site 101
  • Ohio
    • Columbus, Ohio, United States, 43215
      • Site 102
  • Texas
    • San Antonio, Texas, United States, 78218
      • Site 107
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Site 105

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.	Biological: placebo; placebo
Experimental: Imsidolimab; 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.	Drug: Imsidolimab; Humanized Monoclonal Antibody; Other Names: ANB019

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Ichthyosis Area Severity Index (IASI) Total Score at Week 16	IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling & percentage of body surface area (BSA) affected. Degree of erythema & scaling scored from 0 (none) to 4 (very severe) for each of 4 body regions (BR) [A1: head & neck (H&N), A2: upper limbs (UL), A3: trunk (T), A4: lower limbs (LL)]. Percentage of BSA involved for each BR (B1: % in H&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value(0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%= 5, 90%-100%= 6).Total extent was determined using multiplier considering % of total BSA by each BR (C1= 0.1 for H&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL). IASI-Erythema (E)= A1E x B1 x C1 + A2E x B2 x C2 + A3E x B3 x C3 + A4E x B4 x C4 (score 0 to 24) IASI-Scaling (S)= A1S x B1 X C1 + A2S x B2 x C2 + A3S x B3 x C3 + A4S x B4 x C4 (score 0 to 24) IASI total score= IASI-E + IASI-S score ranged from 0 - 48, higher score indicated worse disease state.	Baseline and Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in IASI Total Score at Week 16	IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling, & percentage of BSA affected. Degree of erythema & scaling scored from 0 (none) to 4 (very severe) for each of 4 BR (A1: H&N, A2: UL, A3: T, A4: LL). Percentage of BSA involved for each BR (B1: % in H&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%= 5, 90%-100%= 6). Total extent was determined using a multiplier considering % of total BSA by each BR (C1= 0.1 for H&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL). IASI-E= A1E x B1 x C1 + A2E x B2 x C2 + A3E x B3 x C3 + A4E x B4 x C4 (score 0 to 24) IASI-S= A1S x B1 X C1 + A2S x B2 x C2 + A3S x B3 x C3 + A4S x B4 x C4 (score 0 to 24) IASI total score= IASI-E + IASI-S score ranged from 0 - 48, higher score indicated worse disease state.	Baseline and Week 16
Percentage of Participants Achieving an Improvement of 50% From Baseline in IASI (IASI50) at Week 16	IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling, & percentage of BSA affected. Degree of erythema & scaling scored from 0 (none) to 4 (very severe) for each of 4 BR (A1: H&N, A2: UL, A3: T, A4: LL). Percentage of BSA involved for each BR (B1: % in H&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%= 5, 90%-100%= 6). Total extent was determined using a multiplier considering % of total BSA by each BR (C1= 0.1 for H&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL). IASI-E= A1E x B1 x C1 + A2E x B2 x C2 + A3E x B3 x C3 + A4E x B4 x C4 (score 0 to 24) IASI-S= A1S x B1 X C1 + A2S x B2 x C2 + A3S x B3 x C3 + A4S x B4 x C4 (score 0 to 24) IASI total score= IASI-E + IASI-S score ranged from 0 - 48, higher score indicated worse disease state.	Week 16
Change From Baseline in IASI-E Scores at Week 16	IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling, & percentage of BSA affected. Degree of erythema & scaling scored from 0 (none) to 4 (very severe) for each of 4 BR (A1: H&N, A2: UL, A3: T, A4: LL). Percentage of BSA involved for each BR (B1: % in H&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%= 5, 90%-100%= 6). Total extent was determined using a multiplier considering % of total BSA by each BR (C1= 0.1 for H&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL). IASI-E= A1E x B1 x C1 + A2E x B2 x C2 + A3E x B3 x C3 + A4E x B4 x C4 IASI-E score ranged from 0 - 24, higher score indicated worse disease state.	Baseline and Week 16
Change From Baseline in IASI-S Scores at Week 16	IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling, & percentage of BSA affected. Degree of erythema & scaling scored from 0 (none) to 4 (very severe) for each of 4 BR (A1: H&N, A2: UL, A3: T, A4: LL). Percentage of BSA involved for each BR (B1: % in H&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%= 5, 90%-100%= 6). Total extent was determined using a multiplier considering % of total BSA by each BR (C1= 0.1 for H&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL). IASI-S= A1S x B1 X C1 + A2S x B2 x C2 + A3S x B3 x C3 + A4S x B4 x C4 IASI-S score ranged from 0 - 24, higher score indicated worse disease state.	Baseline and Week 16
Percent Change From Baseline in IASI-E Scores at Week 16	IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling, & percentage of BSA affected. Degree of erythema & scaling scored from 0 (none) to 4 (very severe) for each of 4 BR (A1: H&N, A2: UL, A3: T, A4: LL). Percentage of BSA involved for each BR (B1: % in H&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%= 5, 90%-100%= 6). Total extent was determined using a multiplier considering % of total BSA by each BR (C1= 0.1 for H&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL). IASI-E= A1E x B1 x C1 + A2E x B2 x C2 + A3E x B3 x C3 + A4E x B4 x C4 IASI-E score ranged from 0 - 24, higher score indicated worse disease state.	Baseline and Week 16
Percent Change From Baseline in IASI-S Scores at Week 16	IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling, & percentage of BSA affected. Degree of erythema & scaling scored from 0 (none) to 4 (very severe) for each of 4 BR (A1: H&N, A2: UL, A3: T, A4: LL). Percentage of BSA involved for each BR (B1: % in H&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value (0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%= 5, 90%-100%= 6). Total extent was determined using a multiplier considering % of total BSA by each BR (C1= 0.1 for H&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL). IASI-S= A1S x B1 X C1 + A2S x B2 x C2 + A3S x B3 x C3 + A4S x B4 x C4 IASI-S score ranged from 0 - 24, higher score indicated worse disease state.	Baseline and Week 16
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	An AE was any untoward medical occurrence in a participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE could therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with use of study treatment that did not necessarily have a causal relationship with this treatment. An AE was considered "serious" if there was any of the following outcomes: death, life-threatening adverse event, Inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect, other important medical events. An adverse event was considered TE if the date of onset was during or after first dose of study treatment, or if the AE present at baseline worsened in either intensity or frequency after first dose of study treatment.	From first dose up to study termination (maximum up to 9.4 weeks)

Collaborators and Investigators

• Sponsor: AnaptysBio, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Actual): November 19, 2021
• Study Completion (Actual): November 19, 2021

Study Registration Dates

• First Submitted: December 23, 2020
• First Submitted That Met QC Criteria: January 4, 2021
• First Posted (Actual): January 6, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Interleukin 36; Imsidolimab; IL-36 Receptor
• Additional Relevant MeSH Terms: Skin Diseases; Congenital Abnormalities; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Skin Diseases, Genetic; Skin Abnormalities; Keratosis; Ichthyosiform Erythroderma, Congenital; Ichthyosis; Ichthyosis, Lamellar
• Other Study ID Numbers: ANB019-206; 2020-003476-41 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No