An Extension Study to Evaluate the Long-Term Safety and Efficacy of Afimkibart (RO7790121) in Patients with Atopic Dermatitis who Participated in Previous Afimkibart Clinical Trials

Conditions

Atopic Dermatitis

Brief summary

Incidence and severity of adverse events, serious adverse events, adverse events leading to study treatment discontinuation, adverse events of special interest

Detailed description

Change and percent change from baseline (in parent study) in Eczema Area and Severity Index (EASI) score at each visit, Proportion of participants with EASI50/75/90 at each visit, Proportion of participants achieving a Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) of clear (0) or almost clear (1) with more than or equal to 2-grade improvement from baseline (in the parent study) at each visit, Change from parent baseline (in the parent study) in Participant-Oriented Eczema Measure (POEM) at each visit, Change from parent baseline (in the parent study) in Dermatology Life Quality Index (DLQI) at each visit, Change from baseline (in the parent study) in selected clinical laboratory test results, Change from baseline in selected vital signs, Serum concentration of afimkibart at specified timepoints, Incidence and titres of ADA and NAb

Related papers

No related papers found yet.

Interventions

DRUGRO7790121 placebo/diluent

DRUGRO7790121

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence and severity of adverse events, serious adverse events, adverse events leading to study treatment discontinuation, adverse events of special interest	—

Secondary

Measure	Time frame
Change and percent change from baseline (in parent study) in Eczema Area and Severity Index (EASI) score at each visit, Proportion of participants with EASI50/75/90 at each visit, Proportion of participants achieving a Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) of clear (0) or almost clear (1) with more than or equal to 2-grade improvement from baseline (in the parent study) at each visit, Change from parent baseline (in the parent study) in Participant-Oriented Eczema Measure (POEM) at each visit, Change from parent baseline (in the parent study) in Dermatology Life Quality Index (DLQI) at each visit, Change from baseline (in the parent study) in selected clinical laboratory test results, Change from baseline in selected vital signs, Serum concentration of afimkibart at specified timepoints, Incidence and titres of ADA and NAb	—

Measure

Time frame

Change and percent change from baseline (in parent study) in Eczema Area and Severity Index (EASI) score at each visit, Proportion of participants with EASI50/75/90 at each visit, Proportion of participants achieving a Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) of clear (0) or almost clear (1) with more than or equal to 2-grade improvement from baseline (in the parent study) at each visit, Change from parent baseline (in the parent study) in Participant-Oriented Eczema Measure (POEM) at each visit, Change from parent baseline (in the parent study) in Dermatology Life Quality Index (DLQI) at each visit, Change from baseline (in the parent study) in selected clinical laboratory test results, Change from baseline in selected vital signs, Serum concentration of afimkibart at specified timepoints, Incidence and titres of ADA and NAb

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Countries

France, Germany, Italy, Poland, Spain

Outcome results

None listed