Trial Outcomes & Findings for Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials (NCT NCT04949841)
NCT ID: NCT04949841
Last Updated: 2025-04-08
Results Overview
An AE will be considered treatment emergent if it started after the baseline visit
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
801 participants
Primary outcome timeframe
From baseline up to Week 38
Results posted on
2025-04-08
Participant Flow
This trial enrolled subjects who completed one of the 2 pivotal phase 3 trials with delgocitinib cream 20 mg/g or cream vehicle (parent trials - Trial 1401 \[NCT04871711\] or Trial 1402 \[NCT04872101\]).
Participant milestones
| Measure |
As-needed Treatment With Delgocitinib
Subjects will be treated with delgocitinib cream 20 mg/g twice daily as needed. \>
\> Delgocitinib: Delgocitinib cream 20 mg/g
|
|---|---|
|
Overall Study
STARTED
|
801
|
|
Overall Study
COMPLETED
|
664
|
|
Overall Study
NOT COMPLETED
|
137
|
Reasons for withdrawal
| Measure |
As-needed Treatment With Delgocitinib
Subjects will be treated with delgocitinib cream 20 mg/g twice daily as needed. \>
\> Delgocitinib: Delgocitinib cream 20 mg/g
|
|---|---|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
52
|
|
Overall Study
Pregnancy
|
4
|
|
Overall Study
Lost to Follow-up
|
9
|
|
Overall Study
Lack of Efficacy
|
55
|
|
Overall Study
Various reasons
|
9
|
Baseline Characteristics
Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials
Baseline characteristics by cohort
| Measure |
As-needed Treatment With Delgocitinib
n=801 Participants
Subjects will be treated with delgocitinib cream 20 mg/g twice daily as needed.\>
\> Delgocitinib: Delgocitinib cream 20 mg/g
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
735 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
66 Participants
n=93 Participants
|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 14.4 • n=93 Participants
|
|
Sex: Female, Male
Female
|
512 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
289 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
752 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
28 Participants
n=93 Participants
|
|
Region of Enrollment
Canada
|
162 participants
n=93 Participants
|
|
Region of Enrollment
Netherlands
|
16 participants
n=93 Participants
|
|
Region of Enrollment
Belgium
|
19 participants
n=93 Participants
|
|
Region of Enrollment
Denmark
|
20 participants
n=93 Participants
|
|
Region of Enrollment
Poland
|
180 participants
n=93 Participants
|
|
Region of Enrollment
Italy
|
40 participants
n=93 Participants
|
|
Region of Enrollment
United Kingdom
|
23 participants
n=93 Participants
|
|
Region of Enrollment
France
|
68 participants
n=93 Participants
|
|
Region of Enrollment
Germany
|
215 participants
n=93 Participants
|
|
Region of Enrollment
Spain
|
58 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: From baseline up to Week 38An AE will be considered treatment emergent if it started after the baseline visit
Outcome measures
| Measure |
As-needed Treatment With Delgocitinib
n=801 Participants
Subjects will be treated with delgocitinib cream 20 mg/g twice daily as needed. \>
\> Delgocitinib: Delgocitinib cream 20 mg/g
|
|---|---|
|
Number of Treatment-emergent Adverse Events From Baseline up to Week 38
|
1238 events
|
SECONDARY outcome
Timeframe: From baseline up to Week 38The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Outcome measures
| Measure |
As-needed Treatment With Delgocitinib
n=801 Participants
Subjects will be treated with delgocitinib cream 20 mg/g twice daily as needed. \>
\> Delgocitinib: Delgocitinib cream 20 mg/g
|
|---|---|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
At baseline : 0-Clear
|
77 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
At baseline : 1- Almost Clear
|
83 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
At baseline : 2- Mild
|
345 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
At baseline : 3- Moderate
|
243 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
At baseline : 4- Severe
|
53 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 4 : 0-Clear
|
58 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 4 : 1- Almost Clear
|
76 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 4 : 2- Mild
|
436 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 4 : 3- Moderate
|
189 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 4 : 4- Severe
|
28 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 8 : 0-Clear
|
73 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 8 : 1- Almost Clear
|
82 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 8 : 2- Mild
|
413 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 8 : 3- Moderate
|
167 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 8 : 4- Severe
|
25 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 12 : 0-Clear
|
79 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 12 : 1- Almost Clear
|
76 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 12 : 2- Mild
|
414 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 12 : 3- Moderate
|
152 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 12 : 4- Severe
|
18 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 16 : 0-Clear
|
79 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 16 : 1- Almost Clear
|
77 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 16 : 2- Mild
|
407 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 16 : 3- Moderate
|
147 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 16 : 4- Severe
|
13 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 20 : 0-Clear
|
72 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 20 : 1- Almost Clear
|
90 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 20 : 2- Mild
|
401 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 20 : 3- Moderate
|
123 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 20 : 4- Severe
|
19 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 24 : 0-Clear
|
65 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 24 : 1- Almost Clear
|
67 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 24 : 2- Mild
|
415 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 24 : 3- Moderate
|
118 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 24 : 4- Severe
|
15 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 28 : 0-Clear
|
68 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 28 : 1- Almost Clear
|
79 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 28 : 2- Mild
|
408 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 28 : 3- Moderate
|
109 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 28 : 4- Severe
|
8 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 32 : 0-Clear
|
71 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 32 : 1- Almost Clear
|
67 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 32 : 2- Mild
|
395 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 32 : 3- Moderate
|
118 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 32 : 4- Severe
|
12 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 36 : 0-Clear
|
115 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 36 : 1- Almost Clear
|
124 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 36 : 2- Mild
|
300 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 36 : 3- Moderate
|
111 Participants
|
|
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36
Week 36 : 4- Severe
|
13 Participants
|
SECONDARY outcome
Timeframe: From baseline up to Week 38The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Outcome measures
| Measure |
As-needed Treatment With Delgocitinib
n=801 Participants
Subjects will be treated with delgocitinib cream 20 mg/g twice daily as needed. \>
\> Delgocitinib: Delgocitinib cream 20 mg/g
|
|---|---|
|
Number of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36.
Baseline
|
160 Participants
|
|
Number of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36.
Week 4
|
134 Participants
|
|
Number of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36.
Week 8
|
155 Participants
|
|
Number of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36.
Week 12
|
155 Participants
|
|
Number of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36.
Week 16
|
156 Participants
|
|
Number of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36.
Week 20
|
162 Participants
|
|
Number of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36.
Week 24
|
132 Participants
|
|
Number of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36.
Week 28
|
147 Participants
|
|
Number of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36.
Week 32
|
138 Participants
|
|
Number of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36.
Week 36
|
239 Participants
|
SECONDARY outcome
Timeframe: From baseline up to Week 38The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers \[except fingertips\], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score).
Outcome measures
| Measure |
As-needed Treatment With Delgocitinib
n=801 Participants
Subjects will be treated with delgocitinib cream 20 mg/g twice daily as needed. \>
\> Delgocitinib: Delgocitinib cream 20 mg/g
|
|---|---|
|
HECSI Score at Each Scheduled Visit From Baseline up to Week 36
Baseline
|
30.8 score on a scale
Standard Deviation 36.5
|
|
HECSI Score at Each Scheduled Visit From Baseline up to Week 36
Week 4
|
24.3 score on a scale
Standard Deviation 27.2
|
|
HECSI Score at Each Scheduled Visit From Baseline up to Week 36
Week 8
|
21.4 score on a scale
Standard Deviation 25.3
|
|
HECSI Score at Each Scheduled Visit From Baseline up to Week 36
Week 12
|
20.2 score on a scale
Standard Deviation 23.9
|
|
HECSI Score at Each Scheduled Visit From Baseline up to Week 36
Week 16
|
17.9 score on a scale
Standard Deviation 21.1
|
|
HECSI Score at Each Scheduled Visit From Baseline up to Week 36
Week 20
|
17.8 score on a scale
Standard Deviation 22.5
|
|
HECSI Score at Each Scheduled Visit From Baseline up to Week 36
Week 24
|
17.7 score on a scale
Standard Deviation 19.6
|
|
HECSI Score at Each Scheduled Visit From Baseline up to Week 36
Week 28
|
16.6 score on a scale
Standard Deviation 19.0
|
|
HECSI Score at Each Scheduled Visit From Baseline up to Week 36
Week 32
|
16.9 score on a scale
Standard Deviation 20.0
|
|
HECSI Score at Each Scheduled Visit From Baseline up to Week 36
Week 36
|
15.4 score on a scale
Standard Deviation 20.6
|
SECONDARY outcome
Timeframe: From baseline up to Week 38The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers \[except fingertips\], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score). HECSI-75 is defined as at least 75% improvement in HECSI score from parent trial baseline.
Outcome measures
| Measure |
As-needed Treatment With Delgocitinib
n=801 Participants
Subjects will be treated with delgocitinib cream 20 mg/g twice daily as needed. \>
\> Delgocitinib: Delgocitinib cream 20 mg/g
|
|---|---|
|
Number of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36
At baseline
|
347 Participants
|
|
Number of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36
Week 4
|
391 Participants
|
|
Number of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36
Week 8
|
415 Participants
|
|
Number of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36
Week 12
|
411 Participants
|
|
Number of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36
Week 16
|
432 Participants
|
|
Number of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36
Week 20
|
438 Participants
|
|
Number of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36
Week 24
|
409 Participants
|
|
Number of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36
Week 28
|
414 Participants
|
|
Number of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36
Week 32
|
411 Participants
|
|
Number of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36
Week 36
|
452 Participants
|
SECONDARY outcome
Timeframe: From baseline up to Week 38The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers \[except fingertips\], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score). HECSI-90 is defined as at least 90% improvement in HECSI score from parent trial baseline.
Outcome measures
| Measure |
As-needed Treatment With Delgocitinib
n=801 Participants
Subjects will be treated with delgocitinib cream 20 mg/g twice daily as needed. \>
\> Delgocitinib: Delgocitinib cream 20 mg/g
|
|---|---|
|
Number of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36
At baseline
|
207 Participants
|
|
Number of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36
Week 4
|
195 Participants
|
|
Number of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36
Week 8
|
224 Participants
|
|
Number of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36
Week 12
|
222 Participants
|
|
Number of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36
Week 16
|
229 Participants
|
|
Number of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36
Week 20
|
239 Participants
|
|
Number of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36
Week 24
|
204 Participants
|
|
Number of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36
Week 28
|
236 Participants
|
|
Number of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36
Week 32
|
220 Participants
|
|
Number of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36
Week 36
|
291 Participants
|
Adverse Events
As-needed Treatment With Delgocitinib
Serious events: 27 serious events
Other events: 329 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
As-needed Treatment With Delgocitinib
n=801 participants at risk
As-needed treatment with Delgocitinib cream 20 mg/g (N=801)
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Gastrointestinal disorders
Food poisoning
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
General disorders
Death
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Hepatobiliary disorders
Cholecystitis
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Immune system disorders
Contrast media allergy
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Infections and infestations
Appendicitis
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Infections and infestations
Chronic sinusitis
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Infections and infestations
Complicated appendicitis
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Infections and infestations
Lower respiratory tract infection
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Infections and infestations
Paranasal sinus abscess
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Infections and infestations
Peritonsillar abscess
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Infections and infestations
Pneumonia
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Infections and infestations
Pyelonephritis
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Infections and infestations
Sinusitis aspergillus
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Infections and infestations
Urinary tract infection
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipofibroma
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Nervous system disorders
Facial paralysis
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Psychiatric disorders
Alcoholism
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Reproductive system and breast disorders
Adnexal torsion
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.12%
1/801 • Number of events 1 • From baseline to week 36
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.25%
2/801 • Number of events 2 • From baseline to week 36
|
Other adverse events
| Measure |
As-needed Treatment With Delgocitinib
n=801 participants at risk
As-needed treatment with Delgocitinib cream 20 mg/g (N=801)
|
|---|---|
|
Infections and infestations
COVID-19
|
16.7%
134/801 • Number of events 138 • From baseline to week 36
|
|
Infections and infestations
Influenza
|
3.5%
28/801 • Number of events 28 • From baseline to week 36
|
|
Infections and infestations
Nasopharyngitis
|
16.0%
128/801 • Number of events 161 • From baseline to week 36
|
|
Infections and infestations
Upper respiratory tract infection
|
4.0%
32/801 • Number of events 36 • From baseline to week 36
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
19/801 • Number of events 20 • From baseline to week 36
|
|
Nervous system disorders
Headache
|
2.7%
22/801 • Number of events 27 • From baseline to week 36
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.1%
17/801 • Number of events 21 • From baseline to week 36
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
3.7%
30/801 • Number of events 34 • From baseline to week 36
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor seeks publication of all clinical trials in peer-reviewed journals within 12 months after completion or termination of the clinical trial, regardless of whether the findings are positive or negative. If no publication is submitted by the sponsor within these 12 months, the investigator has the right to publish the results from clinical trial generated by him/herself.
- Publication restrictions are in place
Restriction type: OTHER