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Atopic DermatitisRE-UNITE ADNCT06988605

Real-world Experience Using Nemolizumab in the Treatment of Moderate-to-Severe Atopic Dermatitis in Adolescents & Adults

An observational study of Atopic Dermatitis, run by Galderma R&D at 108 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The main aim of the study is to assess real-world effectiveness of nemolizumab in Atopic Dermatitis (AD) as measured by physician assessment and patient reported outcome (PRO) in clinical practice at Month 6. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Atopic Dermatitis
How many people
1,000 participants
Where
108 sitesin 3 countries
Study dates
14 Jul 2025to 30 Nov 2027
Phase
Observational
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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: The clinical decision for treatment with nemolizumab has to be made by the physicians independently of the participation in this NIS and prior to the informed consent process. Participants greater than or equal to (>=) 12 years of age will be eligible for the trial.

Who may be able to join

  • Participants who, according to the treating physician's decision and in line with the local package label, start treatment with nemolizumab (Nemluvio®).
  • Adolescent and adult participants aged >=12 years with moderate-to-severe AD.
  • Participants who signed the written informed consent form (ICF) or had it signed by their legal representative.

Who cannot join

  • Have contraindication(s) for the use of nemolizumab (Nemluvio®) according to the local package label.
  • Participants who received treatment with a drug under clinical development/investigation within 3 months prior to baseline.
  • Participants who received nemolizumab previously.
  • Participants who are mentally, physically, or linguistically unable to understand the content of the ICF and/or to complete the study questionnaires.

Trial locations and contacts

108 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Galderma Research and Development contact

817-961-5000

clinical.studies@galderma.com

108 sites in 3 countries

United States59 sites, 58 recruiting

  • Galderma Investigational Site - Site 7080

    Auburn, New York, 13021

    Recruiting

  • Galderma Investigational Site 7066

    Auburn Hills, Michigan, 48326-3396

    Not yet recruiting

  • Galderma Investigational Site - 8893

    Birmingham, Alabama, 35244

    Active, not recruiting

  • Galderma Investigational Site 7106

    Bluffton, South Carolina, 29910

    Not yet recruiting

  • Galderma Investigational Site 8597

    Boca Raton, Florida, 33431-5133

    Not yet recruiting

  • Galderma Investigational Site 7085

    Bountiful, Utah, 84010-4801

    Not yet recruiting

  • Galderma Investigational Site 7065

    Brighton, Massachusetts, 02135

    Clinical Project Manager

    Recruiting

  • Galderma Investigational Site 7071

    Caledonia, Michigan, 49316-7478

    Recruiting

  • Galderma Investigational Site 7061

    Castle Rock, Colorado, 80109-8034

    Clinical Project Manager

    Not yet recruiting

  • Galderma Investigational Site 7082

    Cedar Park, Texas, 78613-7875

    Recruiting

  • Galderma Investigational Site 7058

    Chicago, Illinois, 60641

    Recruiting

  • Galderma Investigational Site 7098

    Columbia, Maryland, 21045-2336

    Recruiting

  • Galderma Investigational Site 7087

    Coral Gables, Florida, 33134-2073

    Not yet recruiting

  • Galderma Investigational Site - 7074

    Corona, California, 92882

    Not yet recruiting

  • Galderma Investigational Site 7063

    Cutler Bay, Florida, 33157

    Clinical Project Manager

    Recruiting

  • Galderma Investigational Site 8238

    Dallas, Texas, 75230-5808

    Recruiting

  • Galderma Investigational Site 7081

    Dayton, Ohio, 45414-2799

    Recruiting

  • Galderma Investigational Site # 7052

    East Syracuse, New York, 13057

    Clinical Project Manager

    Recruiting

  • Galderma Investigational Site 7062

    Edinburg, Texas, 78539-4660

    Not yet recruiting

  • Galderma Investigational Site 7059

    Fairfield, Connecticut, 76824

    Clinical Project Manager

    Recruiting

  • Galderma Investigational Site 8636

    Fountain Valley, California, 92708-3701

    Not yet recruiting

  • Galderma Investigational Site 8224

    Fremont, California, 94538-1603

    Recruiting

  • Galderma Investigational Site 8012

    Glenn Dale, Maryland, 20769-9182

    Recruiting

  • Galderma Investigational Site 7108

    Grandville, Michigan, 49418

    Not yet recruiting

  • Galderma Investigational Site 7088

    Grapevine, Texas, 76051

    Recruiting

  • Galderma Investigational Site 7073

    Gresham, Oregon, 97030-2923

    Recruiting

  • Galderma Investigational Site 7134

    Hollywood, Florida, 33021-6748

    Recruiting

  • Galderma Investigational Site 8142

    Indianapolis, Indiana, 46250-2041

    Recruiting

  • Galderma Investigational Site 7101

    Jupiter, Florida, 33477

    Not yet recruiting

  • Galderma Investigational Site 8848

    Las Vegas, Nevada, 89144-0518

    Recruiting

  • Galderma Investigational Site 7057

    Lee's Summit, Missouri, 64064

    Clinical Project Manager

    Recruiting

  • Galderma Investigational Site 7099

    Los Angeles, California, 90024-2801

    Not yet recruiting

  • Galderma Investigational Site 7078

    Miami, Florida, 33173

    Recruiting

  • Galderma Investigationa Site 7104

    Milford, Massachusetts, 01757

    Recruiting

  • Galderma Investigational Site 8725

    Morgantown, West Virginia, 26505-1873

    Recruiting

  • Galderma Investigational Site - 8282

    Mount Kisco, New York, 10549-3035

    Not yet recruiting

  • Galderma Investigational Site - 7051

    New York, New York, 10023

    Recruiting

  • Galderma Investigational Site 7109

    New York, New York, 10028

    Recruiting

  • Galderma Investigational Site 8279

    New York, New York, 10075-0337

    Not yet recruiting

  • Galderma Investigational Site 8553

    Newport Beach, California, 92663-3606

    Recruiting

  • Galderma Investigational Site 7070

    North Miami Beach, Florida, 33162-4708

    Not yet recruiting

  • Galderma Investigational Site 7112

    Oakland Park, Florida, 33334

    Not yet recruiting

  • Galderma Investigational Site 8559

    Philadelphia, Pennsylvania, 19103-4738

    Not yet recruiting

  • Galderma Investigational Site 7103

    Philadelphia, Pennsylvania, 19104

    Not yet recruiting

  • Galdrma Investigational Site - 7077

    Phoenix, Arizona, 85006-2754

    Recruiting

  • Galderma Investigational Site 7060

    Phoenix, Arizona, 85008-3884

    Recruiting

  • Galderma Investigational Site - 8535

    Phoenix, Arizona, 85032-2238

    Recruiting

  • Galderma Investigational Site 7055

    Portsmouth, New Hampshire, 03801-7156

    Recruiting

  • Galderma Investigational Site 7068

    Rockville, Maryland, 20850-6243

    Recruiting

  • Galderma Investigational Site 7064

    Santa Monica, California, 90404-2216

    Not yet recruiting

  • Galderma Investigational Site 7090

    St. Petersburg, Florida, 33713-8012

    Recruiting

  • Galderma Investigational Site 7069

    Sugar Land, Texas, 77478-3842

    Recruiting

  • Galderma Investigational Site 7054

    Tampa, Florida, 33609-2230

    Recruiting

  • Galderma Investigational Site 7107

    Thousand Oaks, California, 91360-7746

    Not yet recruiting

  • Galderma Investigational Site 7072

    Troy, Michigan, 48084-5260

    Not yet recruiting

  • Galderma Investigational Site - 7067

    Tucson, Arizona, 85718

    Not yet recruiting

  • Galderma Investigational Site 7079

    Vienna, Virginia, 22182

    Not yet recruiting

  • Galderma Investigational Site 8618

    Waco, Texas, 76710-4023

    Not yet recruiting

  • Galderma Investigational Site 7083

    West Lafayette, Indiana, 47906-1569

    Not yet recruiting

Other trials in United States

Germany25 sites, 25 recruiting

  • Galderma Investigational Site 6387

    Ahaus, 48683

    Recruiting

  • Galderma Investigational Site 6416

    Augsburg, Bavaria, 86179

    Recruiting

  • Galderma Investigational Site 6383

    Augsburg, 86150

    Recruiting

  • Galderma Investigational Site 6385

    Berlin, 10117

    Recruiting

  • Galderma Investigative Site 6172

    Berlin, 12203

    Clinial Project Manager

    Recruiting

  • Galderma Investigational Site 6366

    Berlin, 13086

    Recruiting

  • Galderma Investigational Site 6398

    Bernau bei Berlin, 16321

    Recruiting

  • Galderma Investigational Site 6386

    Bielefeld, 33647

    Recruiting

  • Galderma Investigational Site 6066

    Buxtehude, 21614

    Clinical Project Manager

    Recruiting

  • Galderma Investigational Site 6369

    Erlangen, Bavaria, 91054

    Recruiting

  • Galderma Investigational Site 6414

    Gladbeck, 45964

    Recruiting

  • Galderma Investigational Site 6418

    Großenhain, 1558

    Recruiting

  • Galderma Investigational Site 6370

    Haslach im Kinzigtal, 77716

    Recruiting

  • Galderma Investigational Site 6420

    Hersbruck, 91217

    Recruiting

  • Galderma Investigational Site 6374

    Karlsruhe, Baden-Wurttemberg, 76133

    Recruiting

  • Galderma Investigational Site 6384

    Koblenz, 56068

    Recruiting

  • Galderma Investigational Site 6412

    Langenau, Baden-Wurttemberg, 89129

    Recruiting

  • Galderma Investigational Site 6013

    Lübeck, 23562

    Recruiting

  • Galderma Investigational Site 6373

    Mainz, 55128

    Recruiting

  • Galderma Investigational Site 6371

    Oberursel, 61440

    Recruiting

  • Galderma Investigational Site 6411

    Oranienburg, 16515

    Recruiting

  • Galderma Investigational Site 6390

    Pforzheim, 75172

    Recruiting

  • Galderma Investigational Site 6372

    Quedlinburg, 6484

    Recruiting

  • Galderma Investigational Site 6417

    Regensburg, Bavaria, 93053

    Recruiting

  • Galderma Investigational Site 6419

    Remscheid, North Rhine-Westphalia, 42897

    Recruiting

Other trials in Germany

United Kingdom24 sites, 24 recruiting

  • Galderma Investigational Site 6392

    Birmingham, West Midlands, B15 2GW

    Recruiting

  • Galderma Investigational Site 6375

    Bridgend, CF31 1RQ

    Recruiting

  • Galderma Investigational Site 6388

    Epsom, KT18 7EG

    Recruiting

  • Galderma Investigational Site 5131

    Harrogate, North Yorkshire, HG2 7SX

    Recruiting

  • Galderma Investigational Site 6394

    Harrow, HA3 7LT

    Recruiting

  • Galderma Investigational Site 6400

    Kings Lynn, Norfolk, PE30 4ET

    Recruiting

  • Galderma Investigational Site 6393

    Kingston upon Thames, KT2 7QB

    Recruiting

  • Galderma Investigational Site 6666

    Kirkcaldy, KY2 5AH

    Not yet recruiting

  • Galderma Investigational Site 6404

    Leeds, West Yorkshire, LS9 7TF

    Recruiting

  • Galderma Investigational Site 6415

    Liverpool, L14 5AB

    Recruiting

  • Galderma Investigational Site 5408

    London, Hampshire, NW3 2QG

    Recruiting

  • Galderma Investigational Site 6395

    London, Surrey, SE5 9RS

    Recruiting

  • Galderma Investigational Site 5210

    London, E11 1NR

    Recruiting

  • Galderma Investigational Site 6368

    London, SE1 9RT

    Recruiting

  • Galderma Investigational Site 6396

    Manchester, M23 2SY

    Recruiting

  • Galderma Investigational Site 6402

    Metropolitan Borough of Wirral, CH49 5PE

    Recruiting

  • Galderma Investigational Site 5431

    Redhill, RH1 5RH

    Recruiting

  • Galderma Investigational Site 6403

    Sandbach, CW11

    Recruiting

  • Galderma Investigational Site 6389

    Sheffield, South Yorkshire, S10 2TH

    Recruiting

  • Galderma Investigational Site 6401

    Southampton, Hampshire, SO16 6YD

    Recruiting

  • Galderma Investigational Site 5989

    Swansea, SA2 8QA

    Recruiting

  • Galderma Investigational Site 6399

    Watford, Hertfordshire, WD18 0HB

    Recruiting

  • Galderma Investigational Site 5944

    Wolverhampton, WV10 0QP

    Recruiting

  • Galderma Investigational Site 6397

    York, Yorkshire, YO31 8HE

    Recruiting

Other trials in United Kingdom

About this study

The main aim of the study is to assess real-world effectiveness of nemolizumab in Atopic Dermatitis (AD) as measured by physician assessment and patient reported outcome (PRO) in clinical practice at Month 6.

Read the detailed description

This prospective, multicenter, non-interventional study (NIS) seeks to evaluate treatment with nemolizumab of moderate-to-severe AD in adolescents and adults over an approximately 12-month period using physician assessments in routine clinical practice and PRO measures.

Treatment with nemolizumab will be determined solely by the participant's physician prior to study enrollment. No additional visits, procedures, or laboratory tests are required outside of routine clinical practice. The visit structure is not defined by the study protocol but is determined by routine medical practice. The visit schedule is intended to facilitate a systematic data assessment according to clinical routine. A sub-study will be completed in Germany and the UK at selected sites in which participants will complete the Peak Pruritus (PP) Numerical Rating Scale (NRS), Average Pruritus (AP) NRS, Sleep Disturbance (SD) NRS, and Pain NRS on a daily basis from Day -1 to Day 14. Data collection will occur remotely, and no clinic visits will be required.

Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06988605
Study groupRoleWhat they receive
NemolizumabParticipants with moderate-to-severe AD who are receiving nemolizumab (Nemluvio®) in routine clinical practice will be observed for approximately 12 months.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Investigator Global Assessment (IGA) at Month 6

    The IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used by the investigator or trained designee to evaluate the global severity of AD and the clinical response to a treatment.

    Measured: At Month 6

  2. Peak Pruritus Numerical Rating Scale (PP NRS) at Month 6

    The PP NRS is a single question validated PRO assessment that participants will use to report the maximum intensity of their pruritus (itch). The PP NRS consists of the following question: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Here, a lower score indicates a better outcome.

    Measured: At Month 6

Secondary outcomes (7)

  1. Eczema Area and Severity Index (EASI) up to Month 12

    The EASI is a validated measure commonly used in clinical trials and clinical practice to assess the severity and the extent of AD signs. The EASI score is a composite score ranging from 0 to 72. The severity of erythema, induration/papulation, excoriation, and lichenification will be assessed by the investigator or trained designee on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. In addition, the extent of AD involvement in each of the 4 body areas will be assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. A higher score indicates severe AD.

    Measured: Up to Month 12

  2. Scoring Atopic Dermatitis (SCORAD) up to Month 12

    The SCORAD is a validated measure commonly used in clinical trials and clinical practice to assess the severity and the extent of AD signs and symptoms. The SCORAD ranges from 0 to 103 and has 3 components: extent, intensity, and patient-reported symptoms of pruritus and sleep loss. The investigator or trained designee will assess the severity of 6 signs of AD (erythema, edema/papulation, oozing/crust, excoriation, lichenification, and dryness), each on a scale ranging from 0 (absence) to 3 (severe). The investigator or trained designee will also ask the participant to evaluate their symptoms of pruritus and sleep loss (average for the last 3 days/nights), each evaluated on a visual analogue scale (VAS) from 0 to 10. A higher score indicates severe AD.

    Measured: Up to Month 12

  3. Investigator Global Assessment (IGA) up to Month 12

    The IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used by the investigator or trained designee to evaluate the global severity of AD and the clinical response to a treatment.

    Measured: Up to Month 12

  4. Peak Pruritus Numerical Rating Scale (PP NRS) up to Month 12

    The PP NRS is a single question validated PRO assessment that participants will use to report the maximum intensity of their pruritus (itch). The PP NRS consists of the following question: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Here, a lower score indicates a better outcome.

    Measured: Up to Month 12

  5. Average Pruritus Numerical Rating Scale (AP NRS) up to Month 12

    The AP NRS is a single question assessment that participants will use to report the average intensity of their pruritus (itch). The AP NRS consists of the following question: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?". Here, a lower score indicates a better outcome.

    Measured: Up to Month 12

  6. Sleep Disturbance Numerical Rating Scale (SD NRS) up to Month 12

    The SD NRS is a single-item PRO for quantifying sleep disturbance. The SD NRS consists of the following question: "On a scale of 0 to 10, with 0 being 'no sleep loss related to the symptoms of my skin disease (atopic dermatitis)' and 10 being 'I did not sleep at all due to the symptoms of my skin disease (atopic dermatitis)', how would you rate your sleep last night?". Here, a lower score indicates a better outcome.

    Measured: Up to Month 12

  7. Pain Numerical Rating Scale (Pain NRS) up to Month 12

    The Pain NRS is a single-item assessment with a potential follow-up question that participants will use to report the average intensity of their pain. The Pain NRS consists of the following question: "Over the past 24 hours, how severe was the pain in your skin?". If the participant rates their pain from 1 to 10, then the following question will be asked: "Do you think the pain is part of the itch, from scratching or both?". Here, a lower score indicates a better outcome.

    Measured: Up to Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2025
  2. Study start14 Jul 2025
  3. Primary completion6 Nov 2026 (estimated)
  4. Study completion30 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06988605
Sponsor's protocol ID
SPR207806
Acronym
RE-UNITE AD
Status last verified
Nov 2025
First submitted
16 May 2025
Last updated
13 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Atopic Dermatitis, run by Galderma R&D at 108 sites in 3 countries.

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 3 inclusion and 4 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 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 sites in United States, Germany, United Kingdom. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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 Galderma Research and Development (817-961-5000, clinical.studies@galderma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Investigator Global Assessment (IGA) at Month 6 (time frame: At Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06988605.

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 13 Mar 2026.

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