CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 462 enrolled
Drug / intervention
ISB 830 - Part 1 Group 1 +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03568162
NCT03568162Phase 2Completed

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of ISB 830 in Adult Subjects With Moderate to Severe Atopic Dermatitis.

Ichnos Sciences SA·interventional·Posted Jun 26, 2018·Updated Aug 23, 2022

In Brief

A Phase 2 clinical trial evaluating ISB 830 - Part 1 Group 1, ISB 830 - Part 1 Group 2, and 4 other interventions for Moderate to Severe Atopic Dermatitis. Completed, enrolled 462 participants across 83 sites in 5 countries.

Detailed Summary

Phase 2b, randomized, double-blinded, placebo-controlled dose range finding study to evaluate the efficacy, safety and tolerability of ISB 830 in adults with moderate to severe atopic dermatitis. The study will be conducted in 2 Parts, with dosing Groups 1-4 comprising Part 1, and dosing Groups 5-6 comprising Part 2. All subjects will receive open-label ISB 830 after a 16 week blinded treatment period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Czechia, Germany, Poland, United States

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJun 26, 2018
Enrollment StartMay 31, 2018
Primary CompletionAug 11, 2020
Study CompletionAug 3, 2021
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 8.0 years ago

Interventions

ISB 830 - Part 1 Group 1drug

Subcutaneous injection (SC) every 2 weeks

ISB 830 - Part 1 Group 2drug

Subcutaneous injection (SC) every 2 weeks

ISB 830 - Part 1 Group 3drug

Subcutaneous injection (SC) every 2 weeks

Placebo - Part 1 Group 4drug

Subcutaneous injection (SC) every 2 weeks

ISB 830 - Part 2 Group 5drug

Subcutaneous injection (SC) every 2 weeks

Placebo - Part 2 Group 6drug

Subcutaneous injection (SC) every 2 weeks