Nemolizumab for Eczema

Recruiting in Palo Alto (17 mi)

+350 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Galderma R&D

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?Long-Term Safety and Efficacy of Nemolizumab in Subjects with Moderate-to-Severe Atopic Dermatitis Description

Eligibility Criteria

This trial is for individuals with moderate-to-severe atopic dermatitis who have previously participated in a nemolizumab study and may benefit from further treatment. Women of childbearing age must commit to abstinence or approved contraception during the study and for 12 weeks after. Exclusions include those with adverse reactions to previous nemolizumab use, current infections, recent COVID-19 infection, pregnancy, breastfeeding, or planning pregnancy.

Inclusion Criteria

You have previously participated in a study for a medication called nemolizumab for atopic dermatitis and may benefit from participating in this study.

I agree to avoid pregnancy during and for 12 weeks after the study by being abstinent or using birth control.

It seems like the criterion you've mentioned is incomplete. Could you please provide more details or context so I can assist you better?

+1 more

Exclusion Criteria

You have had a severe allergic reaction to a medication made from blood or genetically engineered proteins, like monoclonal antibodies.

My body weight is less than 30 kg.

I haven't had any skin infections, needed antibiotics, or had COVID-19 in the last 2 weeks.

+3 more

Participant Groups

The trial is assessing the long-term safety and effectiveness of Nemolizumab in treating moderate-to-severe atopic dermatitis (eczema). It's designed for participants who've been part of prior studies on this medication to continue observing its impacts over an extended period.

1Treatment groups

Experimental Treatment

Group I: NemolizumabExperimental Treatment1 Intervention

Nemolizumab administered via subcutaneous injection

Nemolizumab is already approved in United States, European Union, Japan for the following indications:

🇺🇸 Approved in United States as Nemluvio for: