A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
ConditionAtopic Dermatitis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorPfizer
About this trial
The purpose of this study is to find out how well tilrekimig works, how safe it is, and how it affects the body in adults and adolescents with moderate to severe atopic dermatitis (eczema). Eczema is a condition which can cause dryness, itching, and redness of your skin.
The study is seeking participants who:
* Are aged 12 years or older. * Were confirmed to have atopic dermatitis (AD) at least 12 months ago. * Are not having an effective treatment result from medicines that are applied on skin for AD. * Are considered by their doctors to have moderate to severe AD.
The study treatment period will be 52 weeks. During the 24-week initial treatment period, participants will be randomized to one of three study treatments - tilrekimig, dupilumab, or placebo. Placebo does not have any medicine in it but looks just like the medicine being studied. These treatments will be randomized based on a 2:2:1 ratio. This means out of 1375 participants, about 550 participants will receive tilrekimig, 550 will receive dupilumab, and 275 will receive placebo. This will be followed by a 28-week maintenance period. The last dose of study treatment will be administered at week 48.
Some participants will join the long-term extension (LTE) study C4531008 at week 52. A long-term extension study is an additional study that some participants may be able to join after completing the study if they are interested and meet eligibility requirements. It allows researchers to continue collecting information about how well the study medicine works. It also helps them assess how safe it is when used for a longer period of time. Participants who do not join this study will enter a 12-week safety follow-up period. This period ends 16 weeks after their last dose of study treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
You are [12] years of age or older
You have had moderate-to-severe eczema for at least 1 year
Topical medicines for eczema have not worked well for you
Disqualifiers
Clinically Significant Autoimmune Disease
Significant Infection History or Active Infection
Known or Suspected Immunodeficiency/Immunosuppression
Significant psychiatric illness or suicidality
Trial design
Design model
Parallel
Treatments tested in this trial
Tilrekimig
DrugSubcutaneous Injections at required timepoints
Dupilumab
DrugSubcutaneous Injections at required timepoints based on weight and age.
Placebo for Tilrekimig
Other interventionSubcutaneous Injections at required timepoints
Placebo for Dupilumab
Other interventionSubcutaneous Injections at required timepoints during initial treatment period.
Treatment groups
1,375 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Tilrekimig - Initial treatment periodExperimental treatment 1 intervention
Group B: Placebo - Initial treatment periodPlacebo comparator 2 interventions
Group C: Tilrekimig - Maintenance Period - Dose BExperimental treatment 1 intervention
Group D: Tilrekimig - Maintenance Period - Dose AExperimental treatment 1 intervention
Group E: Dupilumab - Initial treatment periodActive comparator 1 intervention
Group F: Placebo - Maintenance PeriodPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Difference in the proportion of Eczema Area and Severity Index (EASI)75 responders between tilrekimig versus placebo.
Time frame
Week 162
Difference in the proportion of validated Investigator Global Assessment- Atopic Dermatitis (vIGA-AD) 0/1 responders between tilrekimig versus placebo.
Time frame
Week 16Secondary outcomes
1
Difference in the proportion of Peak Pruritis Numerical Rating Score (PP-NRS)4 responders between tilrekimig versus placebo
Time frame
Week 1 through Week 242
Difference in the proportion of PP-NRS4 responders between tilrekimig versus dupilumab
Time frame
Week 1 through Week 243
Incidence of treatment emergent adverse events (AEs), Serious adverse events (SAEs), and AEs leading to discontinuation
Time frame
For each participant from the time the participant provides informed consent, through and including a minimum of 16 weeks after the last administration of the study intervention.4
Incidence of clinically significant changes in vital signs and laboratory tests.
Time frame
For each participant following first administration of the study intervention through the end of study visit (week 64). Source ClinicalTrials.gov