Atopic DermatitisPhase 3NCT07762833
Randomized, Double-blind, Placebo-controlled Study of Nemolizumab in Chinese Subjects With Moderate-to-severe Atopic Dermatitis
A Phase 3 study testing Nemolizumab 30 mg in people with Atopic Dermatitis, run by Galderma R&D at 1 site in China.
Trial summary
This is a bridging study only for Chinese subjects. The goal of this clinical trial is to learn if drug Nemolizumab works to treat moderate to severe AD in over 12 years old male and female. It will also learn about the safety of drug Nemolizumab. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Nemolizumab 30 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2026to 28 Sep 2028
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Chinese subjects aged ≥ 12 years at the screening visit.
- Chronic AD for at least 2 years before the screening visit and confirmed according to American Academy of Dermatology Consensus Criteria (Eichenfield 2014, Appendix 1) at the time of the screening visit.
- EASI score ≥ 16 at both the screening and baseline visits.
- IGA score ≥ 3 (based on the IGA scale ranging from 0 to 4, in which 3 is moderate and 4 is severe) at both the screening and baseline visits.
- AD involvement ≥ 10% of body surface area (BSA) at both the screening and baseline visits.
- Peak (maximum) pruritus NRS score of at least 4.0 at the screening and baseline visit:
Show all 29Show fewer
- Screening PP-NRS score will be determined by a single PP-NRS assessment (score ranging from 0 to 10) for the 24-hour period immediately preceding the screening visit.
- Baseline PP-NRS score will be determined based on the average of daily PP-NRS scores (score ranging from 0 to 10) during the 7 days immediately preceding baseline (rounding not permitted). A minimum of 4 daily scores out of the 7 days immediately preceding baseline is required for this calculation.
- Documented history (within 6 months before the screening visit) of inadequate response to topical medications (TCS with or without TCI). Acceptable documentation includes patient records with information on TCS (with or without TCI) prescription and treatment outcome, or written documentation of the conversation with the subject's treating physician, if different than the investigator.
- Inadequate response to TCS treatments (with or without TCI) is defined as:
- Failure to achieve or maintain remission or low disease activity (equivalent to IGA ≤ 2) despite treatment with a regimen of a medium- or high-potency TCS* (with or without TCI), applied for at least 4 weeks or for the maximum duration per prescribing information; or
- Requirement of a long-term treatment (> 4 weeks) with a high-potency TCS* (with or without TCI) to achieve or maintain remission or low disease activity (equivalent to IGA ≤ 2); Note: If subjects had received a TCI in addition to a TCS, documentation on failure to achieve or maintain remission or low disease activity (equivalent to IGA ≤ 2) is also required.
- or c. If documentation of inadequate response to topical treatments is not available, subjects with a documented recent course of systemic treatment or phototherapy for AD (within 6 months before the visit) will also be considered as inadequate responders to topical treatments.
- If documentation is inadequate, subjects may be rescreened after such documentation is obtained.
- Refer to Appendix 2 for a listing of permitted medium and high-potency TCS medications that are commercially available in China.
- Agree to apply an authorized TCS ± TCI from the screening visit and throughout the study as determined appropriate by the investigator.
- Women of childbearing potential (WOCBP) must agree either to commit to true abstinence throughout the study and for 12 weeks after the last IP injection, when this is in line with the preferred and usual lifestyle of the subject, or to use an effective and approved method of contraception throughout the study and for 12 weeks after the last IP injection. This criterion also applies to a prepubertal female subject who begins menses during the study. Adequate and approved methods of contraception applicable for the subject and/or her partner are defined below:
- Progestogen-only oral hormonal contraception
- Combination of male condom with cap, diaphragm, or sponge with spermicide
- Combined (estrogen- and progestogen-containing) oral, intravaginal, or transdermal hormonal contraception (double barrier methods)
- Injectable or implanted hormonal contraception
- Intrauterine devices
- Bilateral tubal ligation or tube insert (such as the Essure system) at least 3 months before the study
- Vasectomy of partner at least 3 months before the study W Emergency contraception to prevent pregnancy after unprotected intercourse are not acceptable methods for routine use.
- Female subjects of non-childbearing potential must meet one of the following criteria:
- Absence of menstrual bleeding for 1 year prior to screening without any other medical reason, confirmed with follicle stimulating hormone (FSH) level in the postmenopausal range.
- Documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at least 3 months before the study Note: Bilateral tubal ligation is not accepted as a reason for non-childbearing potential.
- Subject willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol.
- Understand and sign an informed consent form/assent form before any investigational procedure(s) are performed
Who cannot join
- Body weight < 30 kg.
- Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 2 weeks before the baseline visit.
- Known or suspected history of immunosuppression, or unusually frequent, recurrent, severe, or prolonged infections, as per investigator's judgment.
- History of lymphoproliferative disease or history of malignancy of any organ system within the last 5 years, except for (1) basal cell carcinoma, squamous cell carcinoma in situ (Bowen's disease), or carcinomas in situ of the cervix that have been treated and have no evidence of recurrence in the last 12 weeks before the baseline visit, or (2) actinic keratoses that have been treated.
- Presence of confounding skin condition that may interfere with study assessments (e.g. Netherton syndrome, psoriasis, cutaneous T-cell lymphoma [mycosis fungoides or Sezary syndrome], contact dermatitis, chronic actinic dermatitis, dermatitis herpetiformis).
- Pregnant women (positive serum pregnancy test result at the screening visit or positive urine pregnancy test at the baseline visit), breastfeeding women, or women planning a pregnancy during the clinical study.
Show all 18Show fewer
- Any medical (e.g., serious cardiac/hepatic/lung [including uncontrolled asthma]/hematologic disease) or psychological condition or any clinically relevant laboratory abnormalities, such as but not limited to elevated ALT or AST (> 3 × upper limit of normal [ULN]) in combination with elevated bilirubin (> 2 × ULN), during the screening period that may put the subject at significant risk according to the investigator's judgment, if he/she participates in the clinical study, or may interfere with study assessments (e.g. poor venous access or needle-phobia).
- Planned or expected major surgical procedure during the clinical study.
- Having received any of the following treatments within the specified timeframe before the baseline visit:
- Treatment(s) Timeframe Coal tar products 2 weeks Topical PDE-4 inhibitor 2 weeks Non-authorized TCS 2 weeks Topical medications, including authorized TCS/TCI, with occlusive dressings (e.g., wet wraps) 2 weeks Systemic corticosteroids (corticosteroid inhalers and intraocular corticosteroids are permitted) 4 weeks Phototherapy or tanning beds 4 weeks Immunosuppressive or immunomodulatory drugs (e.g., cyclosporin A, oral tacrolimus, cyclophosphamide, azathioprine, methotrexate, mycophenolate mofetil, Janus kinase inhibitors) 4 weeks or 5 half-lives (whichever is longer) Biologics and their biosimilars (e.g., etanercept, adalimumab, infliximab, omalizumab) 8 weeks or 5 half-lives (whichever is longer) Dupilumab 10 weeks Live-attenuated vaccines 4 weeks Drugs with a sedative effect such as benzodiazepines, imidazopyridines, barbiturates, sedative antidepressants (e.g., amitriptyline), SSRIs (e.g., paroxetine), or SNRIs, except if these treatments were taken at a stable dose for at least 3 months before screening (Stable treatment with antihistamines with sedative effect is allowed.) 1 week Gabapentinoids (e.g., gabapentin, pregabalin) 4 weeks Cannabinoids 2 weeks Cannabinoids alternative medicine for AD (e.g., traditional Chinese medicine) 2 weeks Aromatic Hydrocarbon Receptor [AhR] modulator (e.g. tapinarof ) 2 weeks
- Abbreviations: AD = atopic dermatitis; PDE-4 = phosphodiesterase-4; SNRI = serotonin-norepinephrine reuptake inhibitor; SSRI = selective serotonin reuptake inhibitor; TCI = topical calcineurin inhibitor; TCS = topical corticosteroid.
- Note: Subjects should not interrupt ongoing treatment with medications important for the subject's health for the sole purpose of participating in this study.
- Subjects unwilling to refrain from using prohibited medications during the clinical study.
- Requiring rescue therapy for AD during the screening period or expected to require systemic rescue therapy during the treatment period.
- Previous treatment with nemolizumab.
- History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, e.g., monoclonal antibody) or to any of the IP excipients.
- History of intolerance to low- or medium-potency TCS or for whom TCS is not advisable (e.g., hypersensitivity, significant skin atrophy).
- Currently participating or participated in any other study of an investigational drug or device, within the past 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) before the screening visit.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Galderma S.A. Galderma S.A., Study Director contact
China1 site, 1 recruiting
- Recruiting
Galderma Investigational Site #6431
Hangzhou, Zhejiang
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Chinese Subjects With Moderate-to-Severe Atopic Dermatitis
This is a bridging study only for Chinese subjects. The goal of this clinical trial is to learn if drug Nemolizumab works to treat moderate to severe AD in over 12 years old male and female. It will also learn about the safety of drug Nemolizumab.
Researchers will compare drug Nemolizumab to a placebo (a look-alike substance that contains no drug) to see if drug Nemolizumab works to treat moderate to severe atopic dermatitis.
Participants will:
Take drug Nemolizumab or a placebo at baseline and every 4 weeks followed, Visit the clinic once every 4 weeks for checkups and tests Keep a diary of their symptoms and the disease situation.
- Conditions
- Atopic Dermatitis
- Being tested
- Nemolizumab 30 mg, Placebo
- Keywords
- Moderate-to-Severe Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nemolizumab 30 mgBiological
Also called Placebo
At the baseline visit, nemo arm subject will receive either 30-mg nemolizumab (CD14152) with a 60-mg loading dose via 2 SC injections, then be administered via a single SC injection every 4 weeks (Q4W) at Week 4, 8, and 12 during the Main Treatment Period. At Week 16, subjects will be offered an opportunity to enter the Extension Treatment Period. At week 16, subjects from nemolizumab arm who entering extension treatment period to receive one injection of 30-mg nemolizumab and one placebo injection; from Week 20 to Week 48, to receive nemolizumab 30-mg Q4W.
PlaceboOther
Also called Nemolizumab 30 mg
At the baseline visit, placebo control arm subjects to receive placebo via 2 SC injections, then be administered placebo via a single SC injection every 4 weeks (Q4W) at Week 4, 8, and 12 during the Main Treatment Period. At Week 16, subjects will be offered an opportunity to enter the Extension Treatment Period. At Week 16 subjects from placebo arm entering Extension Treatment Period receive a LD of 60-mg nemolizumab (two 30-mg injections), from Week 20 to Week 48, all subjects receive nemolizumab 30-mg Q4W.
| Study group | Role | What they receive |
|---|---|---|
| Nemolizumab treatment group | Experimental | 160 subjects will be randomized to Nemolizumab treatment group Receives: Biological: Nemolizumab 30 mg; Other: Placebo |
| Placebo control group | Placebo comparator | 80 subjects will be randomized to placebo control group. Receives: Biological: Nemolizumab 30 mg; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
EASI-75
Proportion of subjects with Eczema Area and Severity Index (EASI)-75 (≥ 75% improvement in EASI from baseline)
Measured: Week 16
IGA success
Proportion of subjects with Investigator Global Assessment (IGA) success (defined as an IGA of 0 [clear] or 1 [almost clear] and a ≥ 2-point reduction from baseline)
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start8 Oct 2026
- Primary completion28 Oct 2027 (estimated)
- Study completion28 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- 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
- At the baseline visit, approximately 240 subjects will be randomized 2:1 to receive either 30-mg nemolizumab with a 60-mg loading dose via 2 SC injections, or placebo via 2 SC injections, stratified by disease severity (measured by IGA).At Week 16, subjects will be offered an opportunity to enter the Extension Treatment Period. At Week 16 subjects from placebo arm entering Extension Treatment Period receive a LD of 60-mg nemolizumab (two 30-mg injections); to maintain blinding, subjects from nemolizumab arm receive one injection of 30-mg nemolizumab and one placebo injection; from Week 20 to Week 48, all subjects receive nemolizumab 30-mg Q4W; follow up visit 12 weeks after final injection of investigational product.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762833
- Sponsor's protocol ID
- SPR.205804
- Status last verified
- Jul 2026
- First submitted
- 10 Aug 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Chinese Subjects With Moderate-to-Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07762833
- Acronym / sponsor ID
- SPR.205804
- Conditions
- Atopic Dermatitis
- Keywords
- Moderate-to-Severe Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2026 (actual)
- Primary completion
- 28 Oct 2027 (estimated)
- Study completion
- 28 Sep 2028 (estimated)
- First posted
- 13 Aug 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.
This is a bridging study only for Chinese subjects. The goal of this clinical trial is to learn if drug Nemolizumab works to treat moderate to severe AD in over 12 years old male and female. It will also learn about the safety of drug Nemolizumab.
Researchers will compare drug Nemolizumab to a placebo (a look-alike substance that contains no drug) to see if drug Nemolizumab works to treat moderate to severe atopic dermatitis.
Participants will:
Take drug Nemolizumab or a placebo at baseline and every 4 weeks followed, Visit the clinic once every 4 weeks for checkups and tests Keep a diary of their symptoms and the disease situation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- At the baseline visit, approximately 240 subjects will be randomized 2:1 to receive either 30-mg nemolizumab with a 60-mg loading dose via 2 SC injections, or placebo via 2 SC injections, stratified by disease severity (measured by IGA).At Week 16, subjects will be offered an opportunity to enter the Extension Treatment Period. At Week 16 subjects from placebo arm entering Extension Treatment Period receive a LD of 60-mg nemolizumab (two 30-mg injections); to maintain blinding, subjects from nemolizumab arm receive one injection of 30-mg nemolizumab and one placebo injection; from Week 20 to Week 48, all subjects receive nemolizumab 30-mg Q4W; follow up visit 12 weeks after final injection of investigational product.
| Arm | Type | Receives |
|---|---|---|
| Nemolizumab treatment group | Experimental | Biological: Nemolizumab 30 mg, Other: Placebo160 subjects will be randomized to Nemolizumab treatment group |
| Placebo control group | Placebo comparator | Biological: Nemolizumab 30 mg, Other: Placebo80 subjects will be randomized to placebo control group. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (29 listed)
- Chinese subjects aged ≥ 12 years at the screening visit.
- Chronic AD for at least 2 years before the screening visit and confirmed according to American Academy of Dermatology Consensus Criteria (Eichenfield 2014, Appendix 1) at the time of the screening visit.
- EASI score ≥ 16 at both the screening and baseline visits.
- IGA score ≥ 3 (based on the IGA scale ranging from 0 to 4, in which 3 is moderate and 4 is severe) at both the screening and baseline visits.
- AD involvement ≥ 10% of body surface area (BSA) at both the screening and baseline visits.
Key exclusion criteria (18 listed)
- Body weight < 30 kg.
- Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 2 weeks before the baseline visit.
- Known or suspected history of immunosuppression, or unusually frequent, recurrent, severe, or prolonged infections, as per investigator's judgment.
- History of lymphoproliferative disease or history of malignancy of any organ system within the last 5 years, except for (1) basal cell carcinoma, squamous cell carcinoma in situ (Bowen's disease), or carcinomas in situ of the cervix that have been treated and have no evidence of recurrence in the last 12 weeks before the baseline visit, or (2) actinic keratoses that have been treated.
- Presence of confounding skin condition that may interfere with study assessments (e.g. Netherton syndrome, psoriasis, cutaneous T-cell lymphoma [mycosis fungoides or Sezary syndrome], contact dermatitis, chronic actinic dermatitis, dermatitis herpetiformis).
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 |
|---|---|---|
| Nemolizumab 30 mgAlso: PlaceboAt the baseline visit, nemo arm subject will receive either 30-mg nemolizumab (CD14152) with a 60-mg loading dose via 2 SC injections, then be administered via a single SC injection every 4 weeks (Q4W) at Week 4, 8, and 12 during the Main Treatment Period. At Week 16, subjects will be offered an opportunity to enter the Extension Treatment Period. At week 16, subjects from nemolizumab arm who entering extension treatment period to receive one injection of 30-mg nemolizumab and one placebo injection; from Week 20 to Week 48, to receive nemolizumab 30-mg Q4W. | Biological | Nemolizumab treatment group, Placebo control group |
| PlaceboAlso: Nemolizumab 30 mgAt the baseline visit, placebo control arm subjects to receive placebo via 2 SC injections, then be administered placebo via a single SC injection every 4 weeks (Q4W) at Week 4, 8, and 12 during the Main Treatment Period. At Week 16, subjects will be offered an opportunity to enter the Extension Treatment Period. At Week 16 subjects from placebo arm entering Extension Treatment Period receive a LD of 60-mg nemolizumab (two 30-mg injections), from Week 20 to Week 48, all subjects receive nemolizumab 30-mg Q4W. | Other | Nemolizumab treatment group, Placebo control group |
Primary outcome
EASI-75
Time frame: Week 16
Proportion of subjects with Eczema Area and Severity Index (EASI)-75 (≥ 75% improvement in EASI from baseline)
IGA success
Time frame: Week 16
Proportion of subjects with Investigator Global Assessment (IGA) success (defined as an IGA of 0 [clear] or 1 [almost clear] and a ≥ 2-point reduction from baseline)
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 16 Oct 2026.
Related trials for Atopic Dermatitis
RecruitingPhase 2
Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
Enrolling by invitationPhase 3
A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis, Eczema
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
Active, not recruitingPhase 2
A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis
Atopic Dermatitis
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
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.
Galderma S.A. Galderma S.A., Study Director contact
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 Nemolizumab 30 mg in people with Atopic Dermatitis, run by Galderma R&D at 1 site in China.
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 29 inclusion and 18 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 16 Oct 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 China. 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 Galderma Research & Development Galderma S.A. (+8621 23159790, Clinical.Studies@galderma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EASI-75 (time frame: Week 16). 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?
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 16 Oct 2026.