NCT04697056

Brief Summary

Efficacy and Safety of imsidolimab in Participants with Ichthyosis

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
19 days until next milestone

Study Start

First participant enrolled

January 25, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2021

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 2, 2023

Completed
Last Updated

September 16, 2025

Status Verified

November 1, 2022

Enrollment Period

10 months

First QC Date

December 23, 2020

Results QC Date

November 17, 2022

Last Update Submit

September 2, 2025

Conditions

Ichthyosis

Keywords

IL-36 ReceptorInterleukin 36Imsidolimab

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Percent Change From Baseline in IASI Total Score at Week 16

    Baseline and Week 16

  • Percentage of Participants Achieving an Improvement of 50% From Baseline in IASI (IASI50) at Week 16

    Week 16

  • Change From Baseline in IASI-E Scores at Week 16

    Baseline and Week 16

  • Change From Baseline in IASI-S Scores at Week 16

    Baseline and Week 16

  • Percent Change From Baseline in IASI-E Scores at Week 16

    Baseline and Week 16

  • +2 more secondary outcomes

Study Arms (2)

Imsidolimab

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Biological: placebo

Interventions

ImsidolimabDRUG

Humanized Monoclonal Antibody

Also known as: ANB019
Imsidolimab
placeboBIOLOGICAL

placebo

Placebo

Eligibility Criteria

Age12 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Site 106

Palo Alto, California, 94304, United States

Location

Site 104

New Haven, Connecticut, 06519, United States

Location

Site 112

Miami, Florida, 33125, United States

Location

Site 101

Chicago, Illinois, 60611, United States

Location

Site 102

Columbus, Ohio, 43215, United States

Location

Site 107

San Antonio, Texas, 78218, United States

Location

Site 105

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Ichthyosis

Condition Hierarchy (Ancestors)

Skin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Limitations and Caveats

As a result of insufficient recruitment of participants, this study was terminated.

Results Point of Contact

Title
Vanda Pharmaceuticals
Organization
Vanda Pharmaceuticals
clinicaltrials@vandapharma.com
202-734-3400

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2020

First Posted

January 6, 2021

Study Start

January 25, 2021

Primary Completion

November 19, 2021

Study Completion

November 19, 2021

Last Updated

September 16, 2025

Results First Posted

March 2, 2023

Record last verified: 2022-11

Locations

US(7)