Atopic Dermatitis
Conditions
Brief summary
This proposed study is a randomized, double-blind, placebo-controlled, 3-arm parallel, multicenter phase II study, designed to explore the efficacy and safety of SHR0302 treatment for patients with moderate to severe atopic dermatitis. The study will be conducted over a 12-week treatment period. Two active doses of SHR0302 will be compared to placebo and improvement in atopic dermatitis will be assessed using the Investigator's Global Score (IGA)
Interventions
DRUGDrug: SHR0302
The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor).
Sponsors
Reistone Biopharma Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subjects between 18-75 years of age (inclusive), male or female, at the time of informed consent * Moderate to severe atopic dermatitis * Capable of providing a signed and dated informed consent form indicating the subject has been informed of all pertinent aspect of the study
Exclusion criteria
* Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study * Subject has a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) or skin infection (bacterial, fungal, or viral) that may affect the evaluation of atopic dermatitis * Subject has a severe comorbidity that may require systemic steroids therapy or other interventions or requires active frequent monitoring (e.g., unstable chronic asthma)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response Which Improvement ≥ 2 From Baseline. | At week 12 | The IGA is a validated assessment instrument used in clinical studies to rate the severity of AD globally. IGA response was defined as IGA score of 0/1 (complete or almost complete clearance of skin lesions) with an improvement in IGA score by ≥ 2 from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Czema Area and Severity Index (EASI) Change. | Up to week 12 | The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD). |
| Percentage of Subjects Achieving Investigator's Global Score (IGA) Response | Up to week 8 | The IGA is a validated assessment instrument used in clinical studies to rate The IGA is a validated assessment instrument used in clinical studies to rate the severity of AD globally. |
| Percent of Pruritus Numerical Rating Scale (NRS) Change | Up to week 12 | The Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Comparator: SHR0302 Dose A Participants randomized in this arm will receive dose A of SHR0302 until end of study at week 12.
Drug: SHR0302: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor). | 35 |
| Active Comparator: SHR0302 Dose B Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 12.
Drug: SHR0302: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor). | 35 |
| Placebo Comparator: Placebo Participants randomized in this arm will receive Placebo of SHR0302 until end of study at week 12.
Drug: SHR0302: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor). | 35 |
| Total | 105 |
Baseline characteristics
| Characteristic | Active Comparator: SHR0302 Dose A | Total | Placebo Comparator: Placebo | Active Comparator: SHR0302 Dose B |
|---|---|---|---|---|
| Age, Continuous | 38.5 years STANDARD_DEVIATION 14.79 | 34.7 years STANDARD_DEVIATION 14.34 | 30.3 years STANDARD_DEVIATION 12.59 | 35.2 years STANDARD_DEVIATION 14.75 |
| Disease duration | 10.91 years STANDARD_DEVIATION 10.214 | 9.51 years STANDARD_DEVIATION 8.807 | 8.67 years STANDARD_DEVIATION 7.624 | 8.95 years STANDARD_DEVIATION 8.468 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants | 105 Participants | 35 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 35 Participants | 105 Participants | 35 Participants | 35 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 15 Participants | 36 Participants | 9 Participants | 12 Participants |
| Sex: Female, Male Male | 20 Participants | 69 Participants | 26 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 13 / 35 | 16 / 35 | 10 / 35 |
| serious Total, serious adverse events | 2 / 35 | 1 / 35 | 0 / 35 |
Outcome results
Primary
The Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response Which Improvement ≥ 2 From Baseline.
The IGA is a validated assessment instrument used in clinical studies to rate the severity of AD globally. IGA response was defined as IGA score of 0/1 (complete or almost complete clearance of skin lesions) with an improvement in IGA score by ≥ 2 from baseline.
Time frame: At week 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Comparator: SHR0302 Dose A | The Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response Which Improvement ≥ 2 From Baseline. | 9 Participants |
| Active Comparator: SHR0302 Dose B | The Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response Which Improvement ≥ 2 From Baseline. | 19 Participants |
| Placebo Comparator: Placebo | The Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response Which Improvement ≥ 2 From Baseline. | 2 Participants |
Secondary
Percentage of Czema Area and Severity Index (EASI) Change.
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD).
Time frame: Up to week 12
Secondary
Percentage of Subjects Achieving Investigator's Global Score (IGA) Response
The IGA is a validated assessment instrument used in clinical studies to rate The IGA is a validated assessment instrument used in clinical studies to rate the severity of AD globally.
Time frame: Up to week 8
Secondary
Percent of Pruritus Numerical Rating Scale (NRS) Change
The Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period.
Time frame: Up to week 12