A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Ichthyosis
- Registration Number
- NCT04697056
- Lead Sponsor
- AnaptysBio, Inc.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
- 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
- A participant with ichthyosis vulgaris, X-linked ichthyosis, or lamellar ichthyosis will be excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Imsidolimab 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. Placebo placebo Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.
- Primary Outcome Measures
Name Time Method Change From Baseline in Ichthyosis Area Severity Index (IASI) Total Score at Week 16 Baseline and 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Treatment Emergent Adverse Events (TEAEs) From first dose up to study termination (maximum up to 9.4 weeks) 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.
Change From Baseline in IASI-E Scores at Week 16 Baseline and 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.Percent Change From Baseline in IASI-S Scores at Week 16 Baseline and 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.Percent Change From Baseline in IASI Total Score at Week 16 Baseline and 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.Percentage of Participants Achieving an Improvement of 50% From Baseline in IASI (IASI50) at Week 16 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.Change From Baseline in IASI-S Scores at Week 16 Baseline and 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.Percent Change From Baseline in IASI-E Scores at Week 16 Baseline and 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.
Trial Locations
- Locations (7)
Site 102
🇺🇸Columbus, Ohio, United States
Site 101
🇺🇸Chicago, Illinois, United States
Site 106
🇺🇸Palo Alto, California, United States
Site 112
🇺🇸Miami, Florida, United States
Site 104
🇺🇸New Haven, Connecticut, United States
Site 105
🇺🇸Salt Lake City, Utah, United States
Site 107
🇺🇸San Antonio, Texas, United States