Atopic Dermatitis
Conditions
Brief summary
This is a clinical study in adult participants with moderate to severe atopic dermatitis (AD). The purpose of the study is to test a new medicine (LEO 138559) given by injection to see if it works to treat AD and what the side effects are when compared with a placebo injection with no medical ingredient. The study will last up to 36 weeks for each participant. The study will include a treatment period of 16 weeks, during which the participants will receive the injections, followed by a period of 16 weeks without treatment with the main purpose of continuing safety evaluations. The participants will regularly visit the clinic for tests and the study doctor will evaluate their AD. The participants will also be asked to answer questions about their AD symptoms and quality of life.
Interventions
DRUGLEO 138559
LEO 138559 is an antibody given by injection just under the skin.
LEO 138559 placebo is given by injection just under the skin. LEO 138559 placebo contains the same excipients in the same concentration as LEO 138559, except for the medical ingredient LEO 138559.
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* 18-64 years old (both included) at screening. * Diagnosis of atopic dermatitis (AD) (as defined by the American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year prior to screening. * Subjects who have a recent history (within 6 months before screening) of inadequate response to treatment with topical medication, or for whom topical treatments are otherwise medically inadvisable. * Eczema Area and Severity Index (EASI) score ≥12 at screening and ≥16 at baseline. * Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score ≥3 at screening and baseline. * Body surface area (BSA) of AD involvement ≥10% at screening and baseline. * Worst Daily Pruritus Numeric Rating Scale (NRS, weekly average) of ≥3 points at baseline.
Exclusion criteria
* Treatment with systemic immunosuppressive/immunomodulating medication, immunoglobulin/blood products, or phototherapy within 4 weeks or 5 half-lives prior to randomization, whichever is longer. * Treatment with biologics within 5 half-lives (if known) or 16 weeks prior to randomization, whichever is longer. * Treatment with topical corticosteroid(s) (TCS), topical calcineurin inhibitor(s) (TCI), topical phosphodiesterase-4 (PDE-4) inhibitor, or other topical prescription treatments within 1 week prior to randomization. * Treatment with a live (attenuated) vaccine within 12 weeks prior to randomization. * Clinically significant active chronic or acute infection requiring systemic treatment within 4 weeks prior to randomization that may compromise the safety of the subject. * Skin infection within 1 week prior to the baseline visit. * Presence of hepatitis B or C infection at screening. * History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening. * Participant has a positive or indeterminate test for tuberculosis at screening. * Participant is pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in EASI Score From Baseline to Week 16 | Week 0 to Week 16 | The Eczema Area and Severity Index (EASI) is a validated measure used in clinical trials to evaluate the extent and severity of atopic dermatitis. EASI is a composite score ranging from 0 to 72 with higher scores indicating a more extensive and/or severe condition. |
Secondary
| Measure | Time frame |
|---|---|
| Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject | Week 0 to Week 16 |
Countries
Canada, Germany, Poland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LEO 138559 Participants will receive injections of LEO 138559 from Week 0 (baseline) to Week 16 (end of treatment).
LEO 138559: LEO 138559 is an antibody given by injection just under the skin. | 29 |
| Placebo Participants will receive injections of placebo from Week 0 (baseline) to Week 16 (end of treatment).
LEO 138559 placebo: LEO 138559 placebo is given by injection just under the skin. LEO 138559 placebo contains the same excipients in the same concentration as LEO 138559, except for the medical ingredient LEO 138559. | 29 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Multiple reasons | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 10 |
Baseline characteristics
| Characteristic | LEO 138559 | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 29 Participants | 58 Participants |
| Age, Continuous | 38.1 years STANDARD_DEVIATION 12.1 | 32.8 years STANDARD_DEVIATION 10.2 | 35.4 years STANDARD_DEVIATION 11.4 |
| Baseline disease severity Baseline EASI score <21 | 14 Participants | 13 Participants | 27 Participants |
| Baseline disease severity Baseline EASI score ≥21 | 15 Participants | 16 Participants | 31 Participants |
| EASI | 26.93 units on a scale STANDARD_DEVIATION 11.77 | 26.12 units on a scale STANDARD_DEVIATION 9.8 | 26.53 units on a scale STANDARD_DEVIATION 10.74 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 28 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 24 Participants | 49 Participants |
| Region of Enrollment Canada | 3 participants | 3 participants | 6 participants |
| Region of Enrollment Germany | 5 participants | 4 participants | 9 participants |
| Region of Enrollment Poland | 16 participants | 19 participants | 35 participants |
| Region of Enrollment United States | 5 participants | 3 participants | 8 participants |
| Sex: Female, Male Female | 17 Participants | 16 Participants | 33 Participants |
| Sex: Female, Male Male | 12 Participants | 13 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 29 |
| other Total, other adverse events | 21 / 29 | 14 / 29 |
| serious Total, serious adverse events | 0 / 29 | 0 / 29 |
Outcome results
Primary
Change in EASI Score From Baseline to Week 16
The Eczema Area and Severity Index (EASI) is a validated measure used in clinical trials to evaluate the extent and severity of atopic dermatitis. EASI is a composite score ranging from 0 to 72 with higher scores indicating a more extensive and/or severe condition.
Time frame: Week 0 to Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 138559 | Change in EASI Score From Baseline to Week 16 | -15.3 score on a scale | Standard Error 2.64 |
| Placebo | Change in EASI Score From Baseline to Week 16 | -3.5 score on a scale | Standard Error 2.91 |
p-value: 0.00395% CI: [-19.6, -4.1]ANCOVA
Secondary
Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject
Time frame: Week 0 to Week 16
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LEO 138559 | Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject | 40 adverse events |
| Placebo | Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject | 26 adverse events |