Atopic Dermatitis
Conditions
Keywords
Immune system diseases, skin diseases, genetic, eczema, atopic dermatitis, Dermatitis, skin diseases, Skin Diseases, Eczematous
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 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.
Interventions
DRUGTilrekimig
Subcutaneous Injections at required timepoints
DRUGDupilumab
Subcutaneous Injections at required timepoints based on weight and age.
OTHERPlacebo for Tilrekimig
Subcutaneous Injections at required timepoints
Subcutaneous Injections at required timepoints during initial treatment period.
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
Key Inclusion Criteria * 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 Key
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 Area and Severity Index (EASI)75 responders between tilrekimig versus placebo. | Week 16 |
| Difference in the proportion of validated Investigator Global Assessment- Atopic Dermatitis (vIGA-AD) 0/1 responders between tilrekimig versus placebo. | Week 16 |
Secondary
| Measure | Time frame |
|---|---|
| Difference in the proportion of Dermatology Life Quality Index (DLQI) responders achieving ≥4-point improvement from baseline between tilrekimig versus placebo. | Weeks 8, 16, and 24 |
| Difference in the proportion of Dermatology Life Quality Index (DLQI) responders achieving ≥4-point improvement from baseline between tilrekimig versus dupilumab | Weeks 8, 16, and 24 |
| Difference in the proportion of Patient Global Impression of Severity (PGI-S) responders achieving a score of 0 or 1 between tilrekimig versus placebo. | Weeks 8, 16, and 24 |
| Difference in the proportion of Patient Global Impression of Severity (PGI-S) responders achieving a score of 0 or 1 between tilrekimig versus dupilumab. | Weeks 8, 16, and 24 |
| Difference in the proportion of Patient Global Impression of Change (PGI-C) responders achieving "Much better" between tilrekimig versus placebo. | Weeks 8, 16, and 24 |
| Difference in the proportion of Patient Global Impression of Change (PGI-C) responders achieving "Much better" between tilrekimig versus dupilumab. | Weeks 8, 16, and 24 |
| Difference in the proportion of Atopic Dermatitis Control Tool (ADCT) responders achieving ≥5-point improvement from baseline between tilrekimig versus placebo. | Weeks 8, 16, and 24 |
| Difference in the proportion of Atopic Dermatitis Control Tool (ADCT) responders achieving ≥5-point improvement from baseline between tilrekimig versus dupilumab. | Weeks 8, 16, and 24 |
| Difference in the mean percent CFB in POEM between tilrekimig versus placebo. | Weeks 8, 16, and 24 |
| Difference in the mean percent CFB in DLQI between tilrekimig versus placebo. | Weeks 8, 16, and 24 |
| Difference in the mean percent CFB in DLQI between tilrekimig versus dupilumab. | Weeks 8, 16, and 24 |
| Difference in the mean percent CFB in Children's Dermatology Life Quality Index (CDLQI) between tilrekimig versus placebo. | Weeks 8, 16, and 24 |
| Difference in the mean percent CFB in CDLQI between tilrekimig versus dupilumab. | Weeks 8, 16, and 24 |
| Difference in the mean percent CFB in PP-NRS weekly average between tilrekimig versus placebo. | Week 1 through week 24 |
| Difference in the mean percent CFB in PP-NRS weekly average between tilrekimig versus dupilumab. | Week 1 through Week 24 |
| Proportion of responders for EASI75, rIGA 0/1, vIGA-AD 0, PP-NRS4, EASI50, EASI90, and EASI100 for tilrekimig doses and placebo. | Weeks 26, 28, 32, 36, 40, 44, 48, 52, and 64 |
| Mean of percent CFB in EASI and BSA for tilrekimig doses and placebo | Weeks 26, 28, 32, 36, 40, 44, 48, 52, and 64 |
| Proportion of maintaining response at Week 52 (defined as meeting ≥50% improvement from baseline in EASI and vIGA-AD <3) for participants who responded to tilrekimig (defined as achieving either EASI75 or vIGA-ADTM 0/1 at Week 24). | Week 52 |
| The proportion of POEM responders achieving ≥4-point improvement from baseline for tilrekimig doses and placebo. | Weeks 28, 36, 44, 52, and 64 |
| The proportion of DLQI responders achieving ≥4-point improvement from baseline for tilrekimig doses and placebo. | Weeks 28, 36, 44, 52, and 64 |
| The proportion of PGI-S responders achieving a score of 0 or 1 for tilrekimig doses and placebo. | Weeks 28, 36, 44, 52, and 64 |
| The proportion of PGI-C responders achieving "Much better" for tilrekimig doses and placebo. | Weeks 28, 36, 44, 52, and 64 |
| The proportion of ADCT responders achieving ≥5-point improvement from baseline for tilrekimig doses and placebo. | Weeks 28, 36, 44, 52, and 64 |
| Mean of CFB in POEM, DLQI, and CDLQI for tilrekimig doses and placebo. | Weeks 28, 36, 44, 52, and 64 |
| Mean of CFB in weekly averages of PP=NRS for tilrekimig doses and placebo. | Weeks 26, 28, 32, 36, 40, 44, 48, 52, and 64 |
| Difference in the mean percent CFB in Body Surface Area (BSA) between tilrekimig versus dupilumab. | Weeks 2, 4, 8, 12, 16, 20 and 24 |
| Difference in the proportion of EASI50, EASI90, and EASI100 responders between tilrekimig versus placebo. | Weeks 2, 4, 8, 12, 14, 16, 20 and 24 |
| Difference in the proportion of EASI50, EASI90, and EASI100 responders between tilrekimig versus dupilumab. | Weeks 2, 4, 8, 12, 14, 16, 20 and 24 |
| Difference in the mean percent CFB in EASI total score between tilrekimig versus placebo. | Weeks 2, 4, 8, 12, 16, 20 and 24 |
| Difference in the mean percent CFB in EASI total score between tilrekimig versus dupilumab. | Weeks 2, 4, 8, 12, 16, 20 and 24 |
| Difference in the proportion of validated Investigator Global Assessment- Atopic Dermatitis (vIGA-AD) 0/1 responders between tilrekimig versus placebo. | Weeks 2, 4, 8, 12, 14, 20, and 24 |
| Difference in the mean percent CFB in Body Surface Area (BSA) between tilrekimig versus placebo. | Weeks 2, 4, 8, 12, 16, 20 and 24 |
| Difference in the proportion of validated Investigator Global Assessment- Atopic Dermatitis (vIGA-AD) 0/1 responders between tilrekimig versus dupilumab. | Weeks 2, 4, 8, 12, 14, 16, 20, and 24 |
| Difference in the proportion of revised Global Investigator Assessment (rIGA) 0/1 responders between tilrekimig versus placebo. | Weeks 2, 4, 8, 12, 14, 16, 20, and 24 |
| Difference in the proportion of revised Global Investigator Assessment (rIGA) 0/1 responders between tilrekimig versus dupilumab. | Weeks 2, 4, 8, 12, 14, 16, 20, and 24 |
| Difference in the proportion of Peak Pruritis Numerical Rating Score (PP-NRS)4 responders between tilrekimig versus placebo | Week 1 through Week 24 |
| Difference in the proportion of PP-NRS4 responders between tilrekimig versus dupilumab | Week 1 through Week 24 |
| Incidence of treatment emergent adverse events (AEs), Serious adverse events (SAEs), 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 following first administration of the study intervention through the end of study visit (week 64). |
| Difference in the proportion of Eczema Area and Severity Index (EASI)75 responders between tilrekimig versus placebo. | Weeks 2, 4, 8, 12, 14, 20, and 24 |
| Difference in the proportion of Patient Oriented Eczema Measure (POEM) responders achieving ≥4-point improvement from baseline between tilrekimig versus placebo. | Weeks 8, 16, and 24 |
| Difference in the proportion of Eczema Area and Severity Index (EASI)75 responders between tilrekimig versus dupilumab. | Weeks 2, 4, 8, 12, 14, 16, 20, and 24 |
| Difference in the proportion of POEM responders achieving ≥4-point improvement from baseline between tilrekimig versus dupilumab. | Weeks 8, 16, and 24 |
Countries
United States
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed