Atopic Dermatitis
Conditions
Keywords
eczema, atopic dermatitis, Immune system diseases, skin diseases, genetic, Dermatitis, Skin Diseases, Eczematous, skin diseases
Brief summary
The purpose of this study is to find out how well tilrekimig works, how safe it is, and how it affects the body when used together with medicated creams or ointments in adults and adolescents with moderate to severe atopic dermatitis (eczema). Eczema (also called atopic dermatitis) is a common skin condition that makes the skin dry, itchy, red, and irritated. * This 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. Participants in this study will randomly receive either tilrekimig or placebo at a 2:1 ratio. A placebo does not have any medicine in it but looks just like the medicine being studied. The study treatment period will be 24 weeks. The last dose of study treatment will be administered at week 20. Some participants will join the long-term extension study C4531008 at week 24. A long-term extension study is an additional study that participants may be able to join after completing the main study. It allows researchers to continue collecting information about how well the study medicine works and 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 study treatment dose.
Interventions
DRUGTilrekimig
Subcutaneous Injections at required timepoints
DRUGPlacebo
Subcutaneous Injections at required timepoints
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants 12 years of age or older * Must meet the following AD criteria: 1. Clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 12 months prior to Day 1 2. An inadequate response to standard of care treatments {eg, at least medium potency topical corticosteroids (TCS)} consistent with AD treatment guidelines 3. Moderate-to-severe eczema for at least 1 year * Adolescent participants must be up to date on immunizations per local guidance.
Exclusion criteria
* Clinically Significant Autoimmune Disease * Significant Infection History or Active Infection * Known or Suspected Immunodeficiency/Immunosuppression * Significant psychiatric illness or suicidality * Clinically significant hepatic, renal, or hematologic abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in the proportion of Eczema and Severity Index (EASI)75 responders between tilrekimig versus placebo | Week 16 |
| Difference in the proportion of Validated Investigator Global Assessment (vIGA)-AD™ 0/1 responders between tilrekimig versus placebo | Week 16 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the proportion of revised investigator's global assessment (rIGA) 0/1 responders between tilrekimig versus placebo | Week 16 | — |
| Difference in the proportion of Eczema and Severity Index (EASI)90 responders between tilrekimig versus placebo | Week 16 | — |
| Difference in the proportion of Dermatology Life Quality Index (DLQI) responders between tilrekimig versus placebo | Week 16 | For participants \>= 16 yrs of age |
| Difference in the proportion of Peak Pruritus Numerical Rating Scale (PP-NRS)4 responders between tilrekimig versus placebo | Weeks 2, 4, 6, 8, and 16 | — |
| Difference in the mean percent change from baseline (CFB) in EASI total score, between tilrekimig versus placebo | Week 16 | — |
| Incidence of treatment emergent Adverse Events (AE)s, Serious Adverse Events (SAE)s and AEs leading to discontinuation | 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. | — |
| Incidence of clinically significant changes in vital signs, and laboratory tests | 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 | — |
| Difference in the proportion of EASI75 responders | Weeks 2, 4, 8, 12, 20, 24 and 36 | — |
| Difference in the proportion of vIGA-AD™ 0/1 response | Weeks 2, 4, 8, 12, 20, 24 and 36 | — |
| Difference in the proportion of rIGA 0/1 response | Weeks 2, 4, 8, 12, 20, 24 and 36 | — |
| Difference in the proportion of vIGA-AD™ 0 response defined as achieving a vIGA-AD(™) score of clear (0) (on a 5-point scale) | Weeks 2, 4, 8, 12, 16, 20, 24 and 36 | — |
| Difference in the proportion of PP-NRS4 response at every week except those included as key secondary endpoints | Week 1 through Week 24 (except Weeks 2, 4, 6, 8, and 16), plus Week 36 | — |
| Difference in the proportion of EASI50, EASI90 and EASI100 (≥50%, ≥90% and 100% improvement from baseline in EASI) | Time frame for both EASI50 and EASI100 is Weeks 2, 4, 8, 12, 16, 20, 24, and 36. Time frame for EASI90 is Weeks 2, 4, 8, 12, 20, 24, and 36. | — |
| Difference in the percent CFB in EASI total score | Weeks 2, 4, 8, 12, 20, 24 and 36 | — |
| Difference in the percent CFB in Body Surface Area (BSA) | Weeks 2, 4, 8, 12, 16, 20, 24 and 36 | — |
| Difference in the proportion of patient Oriented Eczema Measure (POEM) response based on a participant achieving ≥4-point improvement from baseline in POEM | Weeks 4, 8, 16, 24 and 36 | — |
| Difference in the proportion of DLQI response based on a participant achieving ≥4-point improvement from baseline in DLQI at scheduled time points except that included as a key secondary endpoint for participants 16 years or older | Weeks 4, 8, 24 and 36 | — |
| Difference in the proportion of patient global impression of disease severity (PGI-S) response based on a participant achieving a score of None or Mild (0 or 1) in PGI-S | Weeks 4, 8, 16, 24 and 36 | — |
| Difference in the proportion of patient global impression of change in clinical status (PGI-C) response based on a participant achieving "Much Better" in PGI-C | Weeks 4, 8, 16, 24 and 36 | — |
| Difference in the proportion of responders for Atopic Dermatitis Control Tool (ADCT) response based on a participant achieving ≥5-point improvement from baseline in ADCT | Weeks 4, 8, 16, 24 and 36 | — |
| Difference in the mean CFB in POEM | Weeks 4, 8, 16, 24 and 36 | — |
| Difference in the mean CFB in DLQI at scheduled time points for participants 16 years or older | Weeks 4, 8, 16, 24 and 36 | — |
| Difference in the mean CFB in Children's Dermatology Life Quality Index (CDLQI) at scheduled time points for participants 12 to <16 years of age | Weeks 4, 8, 16, 24 and 36 | — |
| Difference in the mean CFB in weekly averages of PP-NRS | Week 1 through Week 24, plus Week 36 | — |
Countries
United States
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed