Who is sponsoring NCT05222516?

NCT05222516 is sponsored by OM Pharma SA.

What condition does NCT05222516 study?

NCT05222516 studies Atopic Dermatitis.

What drugs are being tested in NCT05222516?

Interventions: Broncho-Vaxom, Placebo.

What is the status of NCT05222516?

NCT05222516 is currently TERMINATED.

Last reviewed 2023-08-08 · How we verify

Immunomodulation by OM-85 (Broncho-Vaxom) in Early AD

NCT05222516 PHASE2 TERMINATED

Clinical data suggest that treatment with OM-85, by inducing an early contact with bacterial extracts, could modulate the immunity of children with Atopic Dermatitis, and thus play an active role in the treatment of Atopic Dermatitis. The present trial will investigate the influence of administration of OM-85 in the paediatric population younger than 24 months with moderate atopic dermatitis. The efficacy and safety of OM-85 will be evaluated in children aged 3 to 24 months old with moderate Atopic Dermatitis who may benefit from treatment with OM-85. The placebo treatment period will serve as a reference and has been added to establish efficacy and safety.

Details

Lead sponsor	OM Pharma SA
Phase	PHASE2
Status	TERMINATED
Enrolment	63
Start date	Mon Dec 20 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Thu Jul 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Atopic Dermatitis

Interventions

Broncho-Vaxom
Placebo

Countries

France, Netherlands, Germany, Poland