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Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials

A Phase 3 Extension Trial of DELTA 1 and DELTA 2 to Evaluate the Long-term Safety of a Twice-daily Treatment With Delgocitinib Cream 20 mg/g as Needed for up to 36 Weeks in Adult Subjects With Chronic Hand Eczema (DELTA 3)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04949841
Acronym
DELTA 3
Enrollment
801
Registered
2021-07-02
Start date
2021-08-23
Completion date
2023-09-18
Last updated
2025-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hand Eczema

Brief summary

The purpose of this extension trial is to evaluate the long-term safety of delgocitinib. Subjects will visit the clinic every 4 week to assess the safety and efficacy of the treatment, until Week 36. A final follow-up phone call is planned on Week 38.

Detailed description

Subject who completed 16 weeks of treatment with delgocitinib cream 20 mg/g or vehicle cream twice daily in trials DELTA 1 or DELTA 2 will be offered to roll-over to this extension trial. Subjects will be treated with delgocitinib cream 20 mg/g twice daily only if they need it to control their chronic hand eczema. In the periods when the disease is controlled, no treatment will be administered. Clinic visits every 4 weeks are planned (with the possibility of unscheduled visits) to investigate safety and efficacy of treatment, as well as its effect on patient-reported outcomes (PROs).

Interventions

DRUGDelgocitinib

Delgocitinib cream 20 mg/g

Sponsors

LEO Pharma
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Participants must have met eligibility criteria at screening and baseline in the parent trial (DELTA 1 or DELTA 2). * Participants must have completed the treatment period in the parent trial (to be assessed at baseline visit in this extension trial). * Participants must have complied with the clinical trial protocol in the parent trial to the satisfaction of the investigator. * A woman of childbearing potential must use an acceptable method of birth control throughout the trial up until the end-of-treatment/early termination visit.

Exclusion criteria

* Participants who prematurely discontinued treatment with IMP or initiated rescue medication in the parent trial. * Participants who experienced any adverse event (AE) during participation in the parent trial, which precludes further treatment with delgocitinib cream 20 mg/g in the judgement of the investigator. * Any medical or psychiatric condition that could put the participant at undue risk by participating in the trial, or which, by the investigator's judgment, makes the participant inappropriate for the trial.

Design outcomes

Primary

MeasureTime frameDescription
Number of Treatment-emergent Adverse Events From Baseline up to Week 38From baseline up to Week 38An AE will be considered treatment emergent if it started after the baseline visit

Secondary

MeasureTime frameDescription
Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36From 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).
Number of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36.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).
HECSI Score at Each Scheduled Visit From Baseline up to Week 36From 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).
Number of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36From 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.
Number of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36From 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.

Countries

Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom

Participant flow

Pre-assignment details

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 \[NCT04872101\]).

Participants by arm

ArmCount
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
801
Total801

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAdverse Event7
Overall StudyDeath1
Overall StudyLack of Efficacy55
Overall StudyLost to Follow-up9
Overall StudyPregnancy4
Overall StudyVarious reasons9
Overall StudyWithdrawal by Subject52

Baseline characteristics

CharacteristicAs-needed Treatment With Delgocitinib
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
66 Participants
Age, Categorical
Between 18 and 65 years
735 Participants
Age, Continuous45 years
STANDARD_DEVIATION 14.4
Ethnicity (NIH/OMB)
Hispanic or Latino
21 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
752 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
28 Participants
Region of Enrollment
Belgium
19 participants
Region of Enrollment
Canada
162 participants
Region of Enrollment
Denmark
20 participants
Region of Enrollment
France
68 participants
Region of Enrollment
Germany
215 participants
Region of Enrollment
Italy
40 participants
Region of Enrollment
Netherlands
16 participants
Region of Enrollment
Poland
180 participants
Region of Enrollment
Spain
58 participants
Region of Enrollment
United Kingdom
23 participants
Sex: Female, Male
Female
512 Participants
Sex: Female, Male
Male
289 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
3 / 801
other
Total, other adverse events
329 / 801
serious
Total, serious adverse events
27 / 801

Outcome results

Primary

Number of Treatment-emergent Adverse Events From Baseline up to Week 38

An AE will be considered treatment emergent if it started after the baseline visit

Time frame: From baseline up to Week 38

ArmMeasureValue (NUMBER)
As-needed Treatment With DelgocitinibNumber of Treatment-emergent Adverse Events From Baseline up to Week 381238 events
Secondary

HECSI Score at Each Scheduled Visit From Baseline up to Week 36

The 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).

Time frame: From baseline up to Week 38

ArmMeasureGroupValue (MEAN)Dispersion
As-needed Treatment With DelgocitinibHECSI Score at Each Scheduled Visit From Baseline up to Week 36Baseline30.8 score on a scaleStandard Deviation 36.5
As-needed Treatment With DelgocitinibHECSI Score at Each Scheduled Visit From Baseline up to Week 36Week 424.3 score on a scaleStandard Deviation 27.2
As-needed Treatment With DelgocitinibHECSI Score at Each Scheduled Visit From Baseline up to Week 36Week 821.4 score on a scaleStandard Deviation 25.3
As-needed Treatment With DelgocitinibHECSI Score at Each Scheduled Visit From Baseline up to Week 36Week 1220.2 score on a scaleStandard Deviation 23.9
As-needed Treatment With DelgocitinibHECSI Score at Each Scheduled Visit From Baseline up to Week 36Week 1617.9 score on a scaleStandard Deviation 21.1
As-needed Treatment With DelgocitinibHECSI Score at Each Scheduled Visit From Baseline up to Week 36Week 2017.8 score on a scaleStandard Deviation 22.5
As-needed Treatment With DelgocitinibHECSI Score at Each Scheduled Visit From Baseline up to Week 36Week 2417.7 score on a scaleStandard Deviation 19.6
As-needed Treatment With DelgocitinibHECSI Score at Each Scheduled Visit From Baseline up to Week 36Week 2816.6 score on a scaleStandard Deviation 19
As-needed Treatment With DelgocitinibHECSI Score at Each Scheduled Visit From Baseline up to Week 36Week 3216.9 score on a scaleStandard Deviation 20
As-needed Treatment With DelgocitinibHECSI Score at Each Scheduled Visit From Baseline up to Week 36Week 3615.4 score on a scaleStandard Deviation 20.6
Secondary

Number of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36

The 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.

Time frame: From baseline up to Week 38

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
As-needed Treatment With DelgocitinibNumber of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36Week 12411 Participants
As-needed Treatment With DelgocitinibNumber of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36Week 16432 Participants
As-needed Treatment With DelgocitinibNumber of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36Week 20438 Participants
As-needed Treatment With DelgocitinibNumber of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36Week 24409 Participants
As-needed Treatment With DelgocitinibNumber of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36Week 28414 Participants
As-needed Treatment With DelgocitinibNumber of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36Week 32411 Participants
As-needed Treatment With DelgocitinibNumber of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36Week 36452 Participants
As-needed Treatment With DelgocitinibNumber of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36At baseline347 Participants
As-needed Treatment With DelgocitinibNumber of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36Week 4391 Participants
As-needed Treatment With DelgocitinibNumber of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36Week 8415 Participants
Secondary

Number of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36

The 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.

Time frame: From baseline up to Week 38

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
As-needed Treatment With DelgocitinibNumber of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36At baseline207 Participants
As-needed Treatment With DelgocitinibNumber of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36Week 4195 Participants
As-needed Treatment With DelgocitinibNumber of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36Week 8224 Participants
As-needed Treatment With DelgocitinibNumber of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36Week 12222 Participants
As-needed Treatment With DelgocitinibNumber of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36Week 16229 Participants
As-needed Treatment With DelgocitinibNumber of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36Week 20239 Participants
As-needed Treatment With DelgocitinibNumber of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36Week 24204 Participants
As-needed Treatment With DelgocitinibNumber of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36Week 28236 Participants
As-needed Treatment With DelgocitinibNumber of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36Week 32220 Participants
As-needed Treatment With DelgocitinibNumber of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36Week 36291 Participants
Secondary

Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36

The 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).

Time frame: From baseline up to Week 38

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36At baseline : 0-Clear77 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36At baseline : 1- Almost Clear83 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36At baseline : 2- Mild345 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36At baseline : 3- Moderate243 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36At baseline : 4- Severe53 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 4 : 0-Clear58 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 4 : 1- Almost Clear76 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 4 : 2- Mild436 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 4 : 3- Moderate189 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 4 : 4- Severe28 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 8 : 0-Clear73 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 8 : 1- Almost Clear82 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 8 : 2- Mild413 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 8 : 3- Moderate167 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 8 : 4- Severe25 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 12 : 0-Clear79 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 12 : 1- Almost Clear76 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 12 : 2- Mild414 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 12 : 3- Moderate152 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 12 : 4- Severe18 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 16 : 0-Clear79 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 16 : 1- Almost Clear77 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 16 : 2- Mild407 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 16 : 3- Moderate147 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 16 : 4- Severe13 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 20 : 0-Clear72 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 20 : 1- Almost Clear90 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 20 : 2- Mild401 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 20 : 3- Moderate123 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 20 : 4- Severe19 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 24 : 0-Clear65 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 24 : 1- Almost Clear67 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 24 : 2- Mild415 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 24 : 3- Moderate118 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 24 : 4- Severe15 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 28 : 0-Clear68 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 28 : 1- Almost Clear79 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 28 : 2- Mild408 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 28 : 3- Moderate109 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 28 : 4- Severe8 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 32 : 0-Clear71 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 32 : 1- Almost Clear67 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 32 : 2- Mild395 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 32 : 3- Moderate118 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 32 : 4- Severe12 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 36 : 0-Clear115 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 36 : 1- Almost Clear124 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 36 : 2- Mild300 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 36 : 3- Moderate111 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36Week 36 : 4- Severe13 Participants
Secondary

Number of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36.

The 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).

Time frame: From baseline up to Week 38

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36.Baseline160 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36.Week 4134 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36.Week 8155 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36.Week 12155 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36.Week 16156 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36.Week 20162 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36.Week 24132 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36.Week 28147 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36.Week 32138 Participants
As-needed Treatment With DelgocitinibNumber of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36.Week 36239 Participants

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026