Trial Outcomes & Findings for The Role of Interleukin-1 Beta Targeted Therapy for Patients Suffering From Allergic Contact Dermatitis (NCT NCT05498467)
NCT ID: NCT05498467
Last Updated: 2025-05-20
Results Overview
Number of participants with a lower clinical ICDRGscoring in the active treatment group compared to placebo
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
20 participants
Primary outcome timeframe
2 months
Results posted on
2025-05-20
Participant Flow
Participant milestones
| Measure |
Anakinra
Anakinra: 100 mg Anakinra injections s.c.
|
Placebo
Sodium Chloride 9mg/ml Injection: 9 mg Sodium Chloride injections s.c.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
8
|
|
Overall Study
COMPLETED
|
12
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Role of Interleukin-1 Beta Targeted Therapy for Patients Suffering From Allergic Contact Dermatitis
Baseline characteristics by cohort
| Measure |
Anakinra
n=12 Participants
Anakinra: 100 mg Anakinra injections s.c.
|
Placebo
n=8 Participants
Sodium Chloride 9mg/ml Injection: 9 mg Sodium Chloride injections s.c.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
39.8 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
36.6 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
38.6 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
12 participants
n=5 Participants
|
8 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 monthsNumber of participants with a lower clinical ICDRGscoring in the active treatment group compared to placebo
Outcome measures
| Measure |
Anakinra
n=12 Participants
100 mg Anakinra injections s.c.
|
Placebo
n=8 Participants
9 mg Sodium Chloride injections s.c.
|
|---|---|---|
|
Clinical Reaction
Clinical treatment effect
|
0 Participants
|
0 Participants
|
|
Clinical Reaction
No clinical treatment effect
|
12 Participants
|
8 Participants
|
Adverse Events
Anakinra
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kelvin Yeung
Department of Dermatology and Allergy - Herlev-Gentofte Hospital
Phone: 38673243
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place