NCT03568162

Phase 2b Study to Evaluate the Efficacy and Safety of ISB 830 in Adults With Moderate to Severe Atopic Dermatitis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 462 (actual)
• Sponsor: Ichnos Sciences SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Moderate to Severe Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	ISB 830 - Part 1 Group 1	Subcutaneous injection (SC) every 2 weeks
DRUG	ISB 830 - Part 1 Group 2	Subcutaneous injection (SC) every 2 weeks
DRUG	ISB 830 - Part 1 Group 3	Subcutaneous injection (SC) every 2 weeks
DRUG	Placebo - Part 1 Group 4	Subcutaneous injection (SC) every 2 weeks
DRUG	ISB 830 - Part 2 Group 5	Subcutaneous injection (SC) every 2 weeks
DRUG	Placebo - Part 2 Group 6	Subcutaneous injection (SC) every 2 weeks

Timeline

• Start date: 2018-05-31
• Primary completion: 2020-08-11
• Completion: 2021-08-03
• First posted: 2018-06-26
• Last updated: 2022-08-23
• Results posted: 2022-06-28

Locations

83 sites across 5 countries: United States, Canada, Czechia, Germany, Poland

Regulatory

• FDA-regulated drug study