Nummular EczemaPhase 3LUMINENCT07542483
A Study of Lebrikizumab in Adults With Nummular Eczema
A Phase 3 study testing Lebrikizumab in people with Nummular Eczema, run by Almirall, S.A. at 1 site in Germany.
Trial summary
The main aim of the study is to evaluate the efficacy, safety, and tolerability of lebrikizumab treatment in adult participants with Nummular Eczema (NE) who are not adequately controlled with Topical corticosteroids (TCS) or when this treatment is not medically advisable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nummular Eczema
- What is being tested?
- Lebrikizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 1 siteGermany
- Study dates
- 24 Apr 2026to Feb 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants eligible for inclusion in this trial must fulfil all inclusion criteria per protocol, main criteria are listed below:
- Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, and ability to provide written informed consent in accordance with institutional and regulatory guidelines.
- Adult (aged 18 years or more at the time of Screening) diagnosed clinically with NE, as confirmed by the Investigator.
- Presence of nummular eczema signs and/or symptoms for at least 6 months prior to Screening.
- Investigator Global Assessment score >=3 at both Screening and Baseline/Day 1 visits.
- In the judgement of the Investigator, having inadequate response to TCS.
Who cannot join
- Participants fulfilling any of the exclusion criteria per protocol are not eligible for inclusion in this trial main criteria are listed below:
- Documented history or current presence of moderate-to-severe AD at the Screening visit, or documented diagnosis of moderate-to-severe AD from Screening to Baseline/Day 1 visit (ie, EASI >=16).
- Presence of any skin disease, other than NE or mild AD, that could interfere with assessment of the study outcomes, including but not limited to psoriasis and other forms of eczema (dyshidrotic eczema, stasis dermatitis, asteatotic eczema, and neurodermatitis).
- Presence of any skin manifestations suggestive of psoriasis including but not limited to nail pitting, scalp, palms, soles, or skin folds involvement, as well as personal or family history of psoriasis or psoriatic arthritis.
- Prior treatment at any time with lebrikizumab, dupilumab, tralokinumab, or oral Janus kinase inhibitor.
- Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever was longer, prior to Screening.
Show all 23Show fewer
- Intention to use any concomitant medication that is not permitted by this protocol or failure to undergo the required washout period for a particular prohibited medication.
- History of anaphylaxis as defined by the Sampson criteria.
- Uncontrolled chronic disease that might require multiple intermittent uses of systemic corticosteroids, eg, uncontrolled asthma.
- Have had any of the following types of infection within 3 months of Screening or develop any of these infections before Baseline/Day 1:
- Serious (requiring hospitalisation and/or intravenous or equivalent oral antibiotic treatment, per the Investigator's opinion)
- Opportunistic (as defined by Winthrop 2015) Note: herpes zoster is considered active and ongoing until all vesicles are dry and crusted over
- Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer), including hepatitis B virus and hepatitis C virus infections
- Recurring (including but not limited to herpes zoster, recurring cellulitis, and chronic osteomyelitis) with the exception of uncomplicated herpes simplex infection, which is not considered exclusionary
- Known liver cirrhosis and/or chronic hepatitis of any aetiology.
- Diagnosed active endoparasitic infections or at high risk of these infections.
- Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution, or unusually frequent, recurrent, or prolonged infections, per the Investigator's judgement.
- History of human immunodeficiency virus (HIV) infection or known positive HIV serology.
- In the Investigator's opinion, any clinically significant laboratory test results from the chemistry or haematology tests obtained at the Screening visit.
- History of malignancy, including mycosis fungoides/cutaneous T-cell lymphoma, within 5 years before the Screening visit, except for completely treated in situ carcinoma of the cervix or completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks.
- Severe concomitant illness(es) that in the Investigator's judgement would adversely affect the participation in the study. Any other medical or psychological condition that in the opinion of the Investigator may suggest a new and/or insufficiently understood disease, may present an unreasonable risk to the study participant because of their participation in this clinical trial, may make participation unreliable, or may interfere with study assessments.
- Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
- History of sensitivity and/or allergy to any of the ingredients of the trial medication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Natalia Calderón contact
About this study
Official title: A Phase 3, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre Study With a Double-Blind Extension Evaluating Efficacy and Safety of Lebrikizumab Administered to Adult Patients With Nummular Eczema Who Are Not Adequately Controlled With Topical Corticosteroids or When This Treatment is Not Medically Advisable (LUMINE)
The main aim of the study is to evaluate the efficacy, safety, and tolerability of lebrikizumab treatment in adult participants with Nummular Eczema (NE) who are not adequately controlled with Topical corticosteroids (TCS) or when this treatment is not medically advisable.
- Conditions
- Nummular Eczema
- Being tested
- Lebrikizumab, Placebo
- Keywords
- Nummular Eczema, Dermatitis, Skin Diseases, Lebrikizumab
- Medical subject headings
- Dermatitis, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LebrikizumabDrug
Lebrikizumab SC injection.
PlaceboOther
Matching placebo SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Placebo-controlled Period: Lebrikizumab | Experimental | Not described Receives: Drug: Lebrikizumab |
| Placebo-controlled Period: Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| Blinded Extension Period: Lebrikizumab | Experimental | Not described Receives: Drug: Lebrikizumab |
| Blinded Extension Period: Lebrikizumab + Placebo | Experimental | Not described Receives: Drug: Lebrikizumab; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Investigator Global Assessment (IGA) Score of 0 or 1 and a >=2-point Reduction from Baseline at Week 24
The IGA is an instrument used to globally rate the severity of a participants.
Measured: Baseline, Week 24
Secondary outcomes (19)
Percentage of Participants with Pruritus Numerical Rating Scale (NRS) >=4 at Baseline Achieving a >=4-point Improvement in Pruritus NRS Score from Baseline at Week 24
The Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity during the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable".
Measured: Baseline, Week 24
Absolute Change from Baseline in Dermatology Quality of Life Index (DLQI) to Week 24
The DLQI is a 10-item validated questionnaire completed by the participant used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0 to 3 (not at all, a little, a lot, and very much), giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL.
Measured: Baseline up to Week 24
Percentage of Participants Achieving a 50 Percent (%) Reduction in Body Surface Area (BSA) from Baseline at Week 24
BSA assessment estimates the extent of disease or skin involvement with respect to NE and is expressed as a percentage of total body surface. Body surface area will be determined by the Investigator or designee using the participant palm=1% BSA rule.
Measured: Baseline, Week 24
Absolute Change from Baseline in European Quality of Life Survey (EQ-5D-5L) at Week 24
EQ-5D-5L is a standardised measure of health status that provides a profile of participant health on the day of questionnaire completion. It consists of 2 parts: a descriptive system comprising 5 dimensions (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression), each of which have 5 response levels of perceived problems, and a visual analogue scale scoring overall health on a scale from 0 (worst conceivable state of health) to 100 (best conceivable state of health).
Measured: Baseline, Week 24
Absolute Change from Baseline in Patient Global Assessment of Disease Status (PGADS) at Week 24
PGADS measures static disease severity. Participants are asked "Considering all the ways in which your eczema affects you, indicate how well you are doing" and rate their overall well-being based on a 5-point Likert scale from 1 being "Poor" to 5 being "Excellent".
Measured: Baseline, Week 24
Absolute Change in Skin Pain NRS Score from Baseline at Week 24
The Skin Pain NRS is a two-item measure including an 11-point scale in which participants are asked to rate their skin pain over the prior 24 hours, where 0 is no pain and 10 is the worst imaginable pain.
Measured: Baseline, Week 24
Absolute Change in ItchyQoL from Baseline at Week 24
The ItchyQoL questionnaire is a PRO measure specifically designed to assess the impact of pruritus (itch) on an individual's quality of life. Both versions of ItchyQoL Frequency and Bother will be assessed in the study. The assessment consists of 22 items for Frequency and 15 items for Bother, covering 3 domains: symptoms, functioning, emotions. Each item utilises a 5-point response scale (1: never; 2: rarely; 3: sometimes; 4: often; 5: all of the time). A total score is calculated by summing individual item responses with higher scores indicating greater impact on health-related quality of life.
Measured: Baseline, Week 24
Percentage Change in Eczema Area and Severity Index (EASI) from Baseline at Week 24 in Participants with Atopic Dermatitis (AD)
The EASI is used to assess the severity and extent of AD; it is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and or extensive disease.
Measured: Baseline, Week 24
Change from Baseline in Patient Global Impression of Severity (PGI-S) at Week 24
PGI-S is a single-item assessment of perceived symptom or health status severity using a 5-point verbal rating scale ranging from 1 to 5 (no symptoms experienced, mild, moderate, severe, very severe).
Measured: Baseline, Week 24
Change from Baseline in PGI-S Itch at Week 24
PGI-S is a single-item assessment of perceived symptom or health status severity using a 5-point verbal rating scale ranging from 1 to 5 (no symptoms experienced, mild, moderate, severe, very severe). Participants will be evaluated for PGI-S for itch for overall NE-related health status.
Measured: Baseline, Week 24
Patient Global Impression of Change (PGI-C) at Week 24
The PGI-C is a single-item assessment of perceived change in a symptom or health status. Change is captured using a 7-point verbal rating scale (much worse, moderately worse, a little worse, no change, a little better, moderately better, and much better).
Measured: At Week 24
PGI-C Itch at Week 24
The PGI-C is a single-item assessment of perceived change in a symptom or health status. Change is captured using a 7-point verbal rating scale (much worse, moderately worse, a little worse, no change, a little better, moderately better, and much better). Participants will be evaluated for PGI-C for itch for overall NE-related health status.
Measured: At Week 24
Clinical Global Impression of Change (CGI-C) at Week 24
CGI-C is a single item assessment of change in participants' condition based on clinician assessment at a given timepoint. Change is captured using a 7-point verbal rating scale (much worse, moderately worse, a little worse, no change, a little improved, moderately improved, much improved).
Measured: At Week 24
Change from Baseline in Clinical Global Impression of Severity (CGI-S) at Week 24
CGI-S is a single-item assessment of severity of the participants' condition based on clinician assessment at a given timepoint. Change is captured using a 4-point verbal rating scale (none, mild, moderate, severe).
Measured: Baseline, Week 24
Percentage of Participants with DLQI >=4 at Baseline Achieving DLQI >=4-point Improvement from Baseline at Week 24
The DLQI is a 10-item validated questionnaire completed by the participant used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0 to 3 (not at all, a little, a lot, and very much), giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL.
Measured: Baseline, Week 24
Percentage of Participants Achieving an IGA Score of 0 or 1 and a >=2-point Reduction from Baseline at Week 48 Among those Participants who Achieved this Response at Week 24
The IGA is an instrument used to globally rate the severity of a participants.
Measured: Baseline, Week 48
Percentage of Participants with Pruritus NRS >=4 at Baseline Achieving a >=4-point Improvement in Pruritus NRS Score from Baseline at Week 48, Among those Participants who Achieved this Response at Week 24
The Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity during the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable".
Measured: Baseline, Week 48
Percentage of Participants Achieving DLQI >=4-point Improvement from Baseline, from Week 24 up to Week 48, Among those Participants who Achieved this Response at Week 24
The DLQI is a 10-item validated questionnaire completed by the participant used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0 to 3 (not at all, a little, a lot, and very much), giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL.
Measured: Baseline, Week 24 up to Week 48
Absolute Change from Baseline in DLQI to Week 48
The DLQI is a 10-item validated questionnaire completed by the participant used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0 to 3 (not at all, a little, a lot, and very much), giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL.
Measured: Baseline up to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start24 Apr 2026
- Primary completionAug 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nummular EczemaStudies of the same condition, open and under way.
- More trials run by Almirall, S.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study consists of a placebo-controlled period followed by a blinded extension period.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Almirall, S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542483
- Sponsor's protocol ID
- M-27501-30
- Other IDs
- 2025-522403-17-00, 2025
- Acronym
- LUMINE
- Status last verified
- Jun 2026
- First submitted
- 15 Apr 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre Study With a Double-Blind Extension Evaluating Efficacy and Safety of Lebrikizumab Administered to Adult Patients With Nummular Eczema Who Are Not Adequately Controlled With Topical Corticosteroids or When This Treatment is Not Medically Advisable (LUMINE)
- ClinicalTrials.gov ID
- NCT07542483
- Acronym / sponsor ID
- LUMINE / M-27501-30
- Conditions
- Nummular Eczema
- Keywords
- Nummular Eczema, Dermatitis, Skin Diseases, Lebrikizumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Study start
- 24 Apr 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of the study is to evaluate the efficacy, safety, and tolerability of lebrikizumab treatment in adult participants with Nummular Eczema (NE) who are not adequately controlled with Topical corticosteroids (TCS) or when this treatment is not medically advisable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- The study consists of a placebo-controlled period followed by a blinded extension period.
| Arm | Type | Receives |
|---|---|---|
| Placebo-controlled Period: Lebrikizumab | Experimental | Drug: Lebrikizumab |
| Placebo-controlled Period: Placebo | Placebo comparator | Other: Placebo |
| Blinded Extension Period: Lebrikizumab | Experimental | Drug: Lebrikizumab |
| Blinded Extension Period: Lebrikizumab + Placebo | Experimental | Drug: Lebrikizumab, Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants eligible for inclusion in this trial must fulfil all inclusion criteria per protocol, main criteria are listed below:
- Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, and ability to provide written informed consent in accordance with institutional and regulatory guidelines.
- Adult (aged 18 years or more at the time of Screening) diagnosed clinically with NE, as confirmed by the Investigator.
- Presence of nummular eczema signs and/or symptoms for at least 6 months prior to Screening.
- Investigator Global Assessment score >=3 at both Screening and Baseline/Day 1 visits.
Key exclusion criteria (23 listed)
- Participants fulfilling any of the exclusion criteria per protocol are not eligible for inclusion in this trial main criteria are listed below:
- Documented history or current presence of moderate-to-severe AD at the Screening visit, or documented diagnosis of moderate-to-severe AD from Screening to Baseline/Day 1 visit (ie, EASI >=16).
- Presence of any skin disease, other than NE or mild AD, that could interfere with assessment of the study outcomes, including but not limited to psoriasis and other forms of eczema (dyshidrotic eczema, stasis dermatitis, asteatotic eczema, and neurodermatitis).
- Presence of any skin manifestations suggestive of psoriasis including but not limited to nail pitting, scalp, palms, soles, or skin folds involvement, as well as personal or family history of psoriasis or psoriatic arthritis.
- Prior treatment at any time with lebrikizumab, dupilumab, tralokinumab, or oral Janus kinase inhibitor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LebrikizumabLebrikizumab SC injection. | Drug | Blinded Extension Period: Lebrikizumab, Blinded Extension Period: Lebrikizumab + Placebo, Placebo-controlled Period: Lebrikizumab |
| PlaceboMatching placebo SC injection. | Other | Blinded Extension Period: Lebrikizumab + Placebo, Placebo-controlled Period: Placebo |
Primary outcome
Percentage of Participants Achieving Investigator Global Assessment (IGA) Score of 0 or 1 and a >=2-point Reduction from Baseline at Week 24
Time frame: Baseline, Week 24
The IGA is an instrument used to globally rate the severity of a participants.
19 secondary outcomes
Percentage of Participants with Pruritus Numerical Rating Scale (NRS) >=4 at Baseline Achieving a >=4-point Improvement in Pruritus NRS Score from Baseline at Week 24
Time frame: Baseline, Week 24
Absolute Change from Baseline in Dermatology Quality of Life Index (DLQI) to Week 24
Time frame: Baseline up to Week 24
Percentage of Participants Achieving a 50 Percent (%) Reduction in Body Surface Area (BSA) from Baseline at Week 24
Time frame: Baseline, Week 24
Absolute Change from Baseline in European Quality of Life Survey (EQ-5D-5L) at Week 24
Time frame: Baseline, Week 24
Absolute Change from Baseline in Patient Global Assessment of Disease Status (PGADS) at Week 24
Time frame: Baseline, Week 24
Absolute Change in Skin Pain NRS Score from Baseline at Week 24
Time frame: Baseline, Week 24
Absolute Change in ItchyQoL from Baseline at Week 24
Time frame: Baseline, Week 24
Percentage Change in Eczema Area and Severity Index (EASI) from Baseline at Week 24 in Participants with Atopic Dermatitis (AD)
Time frame: Baseline, Week 24
Change from Baseline in Patient Global Impression of Severity (PGI-S) at Week 24
Time frame: Baseline, Week 24
Change from Baseline in PGI-S Itch at Week 24
Time frame: Baseline, Week 24
Patient Global Impression of Change (PGI-C) at Week 24
Time frame: At Week 24
PGI-C Itch at Week 24
Time frame: At Week 24
Clinical Global Impression of Change (CGI-C) at Week 24
Time frame: At Week 24
Change from Baseline in Clinical Global Impression of Severity (CGI-S) at Week 24
Time frame: Baseline, Week 24
Percentage of Participants with DLQI >=4 at Baseline Achieving DLQI >=4-point Improvement from Baseline at Week 24
Time frame: Baseline, Week 24
Percentage of Participants Achieving an IGA Score of 0 or 1 and a >=2-point Reduction from Baseline at Week 48 Among those Participants who Achieved this Response at Week 24
Time frame: Baseline, Week 48
Percentage of Participants with Pruritus NRS >=4 at Baseline Achieving a >=4-point Improvement in Pruritus NRS Score from Baseline at Week 48, Among those Participants who Achieved this Response at Week 24
Time frame: Baseline, Week 48
Percentage of Participants Achieving DLQI >=4-point Improvement from Baseline, from Week 24 up to Week 48, Among those Participants who Achieved this Response at Week 24
Time frame: Baseline, Week 24 up to Week 48
Absolute Change from Baseline in DLQI to Week 48
Time frame: Baseline up to Week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Nummular Eczema
Enrolling by invitationPhase 2
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Study of Dupilumab to Demonstrate Efficacy in Subjects With Nummular Eczema
Nummular Eczema
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Natalia Calderón contact
Study Director study director
Almirall, S.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lebrikizumab in people with Nummular Eczema, run by Almirall, S.A. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Estrella Garcia (+34620985953, gco@almirall.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Investigator Global Assessment (IGA) Score of 0 or 1 and a >=2-point Reduction from Baseline at Week 24 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.