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

Completed · Phase 2 · Has a placebo group

Conditions studied: Moderate to Severe Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT03568162

Run by

Ichnos Sciences SA

People needed

462

Starts

2018-05-31

Expected to finish

2021-08-03

Last updated by the study team

2022-08-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects aged ≥18 years with physician diagnosis of atopic dermatitis for >1 year as defined by American Academy of Dermatology Consensus Criteria.
• Atopic dermatitis involvement of ≥10% of body surface area at screening and baseline.
• EASI score of ≥12 at screening or ≥16 at baseline.
• IGA score of ≥3 at screening and baseline (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe)
• Baseline Pruritus Numerical Rating Scale (NRS) score for maximum itch intensity ≥3 over the previous 24 hours.

You may not qualify if…

• Pregnant or lactating women.
• Prior treatment with ISB 830
• Treatment with biologics
• Systemic corticosteroids, immunosuppressive/immunomodulatory drugs or phototherapy within 4 weeks of baseline
• Active chronic or acute infection requiring systemic treatment

Where it is running

• Ichnos Investigational Site 120 — Clovis, California, United States
• Ichnos Investigational Site 105 — Rolling Hills Estates, California, United States
• Ichnos Investigational Site 106 — Bridgeport, Connecticut, United States
• Ichnos Investigational Site 146 — Danbury, Connecticut, United States
• Ichnos Investigational Site 142 — Brandon, Florida, United States
• Ichnos Investigational Site 143 — Fort Myers, Florida, United States
• Ichnos Investigational Site 148 — Lake City, Florida, United States
• Ichnos Investigational Site 141 — Lake Worth, Florida, United States
• Ichnos Investigational Site 140 — Miami, Florida, United States
• Ichnos Investigational Site 123 — Miami, Florida, United States
• Ichnos Investigational Site 147 — Ormond Beach, Florida, United States
• Ichnos Investigational site 101 — Tampa, Florida, United States
• Ichnos Investigational Site 135 — Tampa, Florida, United States
• Ichnos Investigational Site 115 — Newnan, Georgia, United States
• Ichnos Investigational Site 139 — Savannah, Georgia, United States
• Ichnos Investigational Site 112 — Plainfield, Indiana, United States
• Ichnos Investigational Site 125 — West Des Moines, Iowa, United States
• Ichnos Investigational Site109 — New Orleans, Louisiana, United States
• Ichnos Investigational Site 126 — St Louis, Missouri, United States
• Ichnos Investigational Site 144 — Las Vegas, Nevada, United States
• Ichnos Investigational Site 117 — Verona, New Jersey, United States
• Glenmark Investigational Site 102 — Forest Hills, New York, United States
• Ichnos Investigational Site 114 — Medford, Oregon, United States
• Ichnos Investigational Site 133 — Hazleton, Pennsylvania, United States
• Ichnos Investigational Site 129 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.