Atopic Dermatitis
Conditions
Brief summary
This study will assess long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with Atopic Dermatitis (AD) who participated in previous afimkibart clinical trials.
Interventions
DRUGAfimkibart
Afimkibart SC injection will be administered as per the schedule defined in the protocol.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ability and willingness to comply with all aspects of the protocol including completion of the efficacy assessments (EASI and IGA), clinical outcome assessment instruments (DLQI, POEM), and safety and PK sample collections for the duration of the study Parent Clinical Trial-Specific Criteria: * Study CS45570 participants who continued to be evaluated at the Week 36 follow up visit and achieved =\> EASI50 response from study baseline
Exclusion criteria
* Evidence of other skin conditions that would interfere with the assessment of AD * Withdrawal of consent and/or premature discontinuation from parent study * Any permanent discontinuation of study drug in parent study * History of severe allergic reaction or anaphylactic reaction to any biologic agent or known hypersensitivity to any component of Afimkibart
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Adverse Events | From Baseline up to 6 years |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline (in Parent Study) in Eczema Area and Severity Index (EASI) Score at Each Visit | Baseline, Up to 6 years |
| Percent Change From Baseline (in Parent Study) in EASI Score at Each Visit | Baseline, Up to 6 years |
| Percentage of Participants With EASI-50 at Each Visit | Up to 6 years |
| Percentage of Participants with EASI-75 at Each Visit | Up to 6 years |
| Percentage of Participants with EASI-90 at Each Visit | Up to 6 years |
| Percentage of Participants who Achieve Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) of Clear (0) or Almost clear (1) at Each Visit | From Baseline up to 6 years |
| Change from Baseline (in the parent study) in Participant-Oriented Eczema Measure (POEM) at Each Visit | Baseline, Up to 6 years |
| Change from Baseline (in the parent study) in Dermatology Life Quality Index (DLQI) at Each Visit | Baseline, Up to 6 years |
| Serum Concentration of Afimkibart at Specified Timepoints | Pre-dose on Day 1, Weeks 2, 10, 18, 26, 34, 42, 50 74, 98, 122, 146, 170, 194, 218, 242, 266, 290 and 14 weeks after last dose |
| Percentage of Participants with Anti-Drug Antibodies (ADAs) to Afimkibart | From Baseline up to 6 years |
| Percentage of Participants with Neutralizing Antibody (NAb) to Afimkibart | From Baseline up to 6 years |
Countries
Brazil, Canada, Germany, Italy, Poland, Spain, United States
Contacts
CONTACTReference Study ID Number: CS45943 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed