Trial Outcomes & Findings for A Phase II Study in Adult Patients With Moderate to Severe Atopic Dermatitis (NCT NCT04162899)
NCT ID: NCT04162899
Last Updated: 2023-05-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
105 participants
Primary outcome timeframe
At week 12
Results posted on
2023-05-09
Participant Flow
Participant milestones
| Measure |
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).
|
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).
|
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).
|
|---|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
35
|
|
Overall Study
COMPLETED
|
29
|
32
|
23
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase II Study in Adult Patients With Moderate to Severe Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Active Comparator: SHR0302 Dose A
n=35 Participants
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).
|
Active Comparator: SHR0302 Dose B
n=35 Participants
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).
|
Placebo Comparator: Placebo
n=35 Participants
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).
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.5 years
STANDARD_DEVIATION 14.79 • n=5 Participants
|
35.2 years
STANDARD_DEVIATION 14.75 • n=7 Participants
|
30.3 years
STANDARD_DEVIATION 12.59 • n=5 Participants
|
34.7 years
STANDARD_DEVIATION 14.34 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Disease duration
|
10.91 years
STANDARD_DEVIATION 10.214 • n=5 Participants
|
8.95 years
STANDARD_DEVIATION 8.468 • n=7 Participants
|
8.67 years
STANDARD_DEVIATION 7.624 • n=5 Participants
|
9.51 years
STANDARD_DEVIATION 8.807 • n=4 Participants
|
PRIMARY outcome
Timeframe: At week 12The 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.
Outcome measures
| Measure |
Active Comparator: SHR0302 Dose A
n=35 Participants
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).
|
Active Comparator: SHR0302 Dose B
n=35 Participants
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).
|
Placebo Comparator: Placebo
n=35 Participants
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).
|
|---|---|---|---|
|
The Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response Which Improvement ≥ 2 From Baseline.
|
9 Participants
|
19 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to week 12The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to week 8The 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to week 12The Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period.
Outcome measures
Outcome data not reported
Adverse Events
Active Comparator: SHR0302 Dose A
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Active Comparator: SHR0302 Dose B
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo Comparator: Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Comparator: SHR0302 Dose A
n=35 participants at risk
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).
|
Active Comparator: SHR0302 Dose B
n=35 participants at risk
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).
|
Placebo Comparator: Placebo
n=35 participants at risk
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).
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
5.7%
2/35 • 12 weeks
|
2.9%
1/35 • 12 weeks
|
0.00%
0/35 • 12 weeks
|
Other adverse events
| Measure |
Active Comparator: SHR0302 Dose A
n=35 participants at risk
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).
|
Active Comparator: SHR0302 Dose B
n=35 participants at risk
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).
|
Placebo Comparator: Placebo
n=35 participants at risk
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).
|
|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
5.7%
2/35 • 12 weeks
|
2.9%
1/35 • 12 weeks
|
0.00%
0/35 • 12 weeks
|
|
Blood and lymphatic system disorders
Leukocytosis
|
8.6%
3/35 • 12 weeks
|
0.00%
0/35 • 12 weeks
|
0.00%
0/35 • 12 weeks
|
|
Infections and infestations
Folliculitis
|
0.00%
0/35 • 12 weeks
|
5.7%
2/35 • 12 weeks
|
0.00%
0/35 • 12 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/35 • 12 weeks
|
5.7%
2/35 • 12 weeks
|
0.00%
0/35 • 12 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
2.9%
1/35 • 12 weeks
|
5.7%
2/35 • 12 weeks
|
0.00%
0/35 • 12 weeks
|
|
Investigations
Blood pressure increased
|
0.00%
0/35 • 12 weeks
|
5.7%
2/35 • 12 weeks
|
0.00%
0/35 • 12 weeks
|
|
Investigations
Transaminases increased
|
5.7%
2/35 • 12 weeks
|
2.9%
1/35 • 12 weeks
|
8.6%
3/35 • 12 weeks
|
|
Investigations
Tri-iodothyronine free increased
|
5.7%
2/35 • 12 weeks
|
2.9%
1/35 • 12 weeks
|
11.4%
4/35 • 12 weeks
|
|
Investigations
Weight decreased
|
0.00%
0/35 • 12 weeks
|
0.00%
0/35 • 12 weeks
|
5.7%
2/35 • 12 weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/35 • 12 weeks
|
5.7%
2/35 • 12 weeks
|
2.9%
1/35 • 12 weeks
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
8.6%
3/35 • 12 weeks
|
5.7%
2/35 • 12 weeks
|
0.00%
0/35 • 12 weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
5.7%
2/35 • 12 weeks
|
2.9%
1/35 • 12 weeks
|
2.9%
1/35 • 12 weeks
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.7%
2/35 • 12 weeks
|
8.6%
3/35 • 12 weeks
|
0.00%
0/35 • 12 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/35 • 12 weeks
|
5.7%
2/35 • 12 weeks
|
0.00%
0/35 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place