Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis (ATLANTIS)

• ClinicalTrials.gov Identifier: NCT05769777
• Recruitment Status: Recruiting
• First Posted: March 15, 2023
• Last Update Posted: May 10, 2024
• Sponsor: Sanofi
• Information provided by (Responsible Party): Sanofi

Study Description

Brief Summary:

This is a single group, 1-arm, long-term safety study for treatment of participants with moderate to severe atopic dermatitis (AD).

The purpose of this study is to characterize the long-term safety and efficacy of amlitelimab in treated participants with age ≥12 years old with moderate to severe AD.

The study duration per participant will be up to 180 weeks, including:

• A screening period of up to 2 to 4 weeks
• An open label treatment period of up to 160 weeks (approximately 3 years)
• A post-treatment safety follow-up period of at least 20 weeks after the last dose administration

The planned number of visits will be 26 visits.

Condition or disease	Intervention/treatment	Phase
Dermatitis Atopic	Drug: Amlitelimab	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 901 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label Multinational, Multicenter Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
• Actual Study Start Date: April 3, 2023
• Estimated Primary Completion Date: October 9, 2028
• Estimated Study Completion Date: October 9, 2028

Arms and Interventions

Arm	Intervention/treatment
Experimental: Amlitelimab; Subcutaneous injection as per protocol	Drug: Amlitelimab; Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous (SC)

Outcome Measures

Primary Outcome Measures :

1. Percentage of participants who experienced Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to end of study (EOS) (Week 176) ]
   Percentage of participants who experienced TEAEs from baseline during the study
2. Percentage of participants who experienced Treatment-Emergent Serious Adverse Events (TESAEs) [ Time Frame: Baseline up to EOS (Week 176) ]
   Percentage of participants who experienced TESAEs from baseline during the study

Secondary Outcome Measures :

1. Percentage of participants who experienced Treatment-Emergent Adverse Events of Special Interest (AESI) [ Time Frame: Baseline up to EOS (Week 176) ]
   Percentage of participants who experienced AESI from baseline during the study
2. Percentage of participants with Potentially Clinically Significant Abnormalities (PCSA) for vital signs and clinical laboratory assessments, and electrocardiogram (ECG) [ Time Frame: Baseline up to EOS (Week 176) ]
3. Percentage of participants discontinued from study treatment due to Adverse Events (AEs) [ Time Frame: Baseline up to EOS (Week 176) ]
4. Percent change from baseline in Eczema Area and Severity Index (EASI) score [ Time Frame: Baseline to EOS (Week 176) ]
   The EASI is an Investigator-assessed tool used to measure the extent (area) and severity of AD. The severity is assessed based on 4 disease characteristics (erythema, induration/papulation, excoriation and lichenification). The extent of involvement of AD is assessed in 4 body regions (head/neck, trunk, upper extremities and lower extremities). Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.
5. Proportion of participants with at least a ≥75% reduction in EASI score (EASI-75) from baseline [ Time Frame: Baseline to EOS (Week 176) ]
   EASI75: ≥ 75% reduction in EASI score from baseline
6. Proportion of participants with EASI-50 /EASI-90 /EASI-100 [ Time Frame: Baseline to EOS (Week 176) ]
   EASI-50: ≥50% reduction in EASI score from baseline; EASI-90: ≥90% reduction in EASI score from baseline; EASI-100: ≥100% reduction in EASI score from baseline.
7. Proportion of participants with Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction of ≥2 points from baseline [ Time Frame: Baseline to EOS (Week 176) ]
   The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
8. Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear) with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting) from baseline [ Time Frame: Baseline to EOS (Week 176) ]
   The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
9. Change in percent Body Surface Area (BSA) affected by AD from baseline [ Time Frame: Baseline to EOS (Week 176) ]
   BSA affected by AD will measure the extent (area) of the disease.
10. Percent change in Scoring Atopic Dermatitis (SCORAD) index from baseline [ Time Frame: Baseline to EOS (Week 176) ]
    The SCORAD Index is a clinical tool used to standardise the evaluation of the extent and severity of AD. To determine the extent of AD, the affected area (A) as a percentage of the whole body is determined, with a maximum score of 100%. The severity (B) of 6 specific symptoms of AD (redness, swelling, oozing/crusting, scratch marks, skin thickening [lichenification], dryness [area where there is no inflammation]) is assessed on a 4-point scale, with a maximum score of 18: none (0), mild (1), moderate (2) or severe (3). Subjective symptoms (C): itch and sleeplessness are recorded as scored by the participants or relative on a visual analogue scale (VAS), where 0 = no itch (or sleeplessness) and 10 = worst imaginable itch (or sleeplessness), with a maximum possible score of 20.
11. Proportion of participants requiring rescue treatment at each visit [ Time Frame: Baseline to EOS (Week 176) ]
12. Proportion of participants with ≥4-point reduction in weekly average of daily Peak Pruritus-Numerical Rating Scale (PP-NRS) from baseline in participants with baseline weekly average of daily PP-NRS ≥4 [ Time Frame: Baseline to EOS (Week 176) ]
    The PP-NRS is a single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD during the past 24 hours, with 0 = no itch and 10 = worst itch imaginable.
13. Percent change in weekly average of daily PP-NRS from baseline [ Time Frame: Baseline to EOS (Week 176) ]
    The PP-NRS is a single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD during the past 24 hours, with 0 = no itch and 10 = worst itch imaginable.
14. Change in weekly average of daily Skin Pain-Numerical Rating Scale (SP-NRS) from baseline [ Time Frame: Baseline to EOS (Week 176) ]
    The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD during the past 24 hours, with 0 = no pain and 10 = worst possible pain imaginable.
15. Proportion of participants with a reduction in weekly average of daily SP-NRS ≥4 from baseline in participants with baseline weekly average of daily SP-NRS ≥4 [ Time Frame: Baseline to EOS (Week 176) ]
    The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD during the past 24 hours, with 0 = no pain and 10 = worst possible pain imaginable.
16. Change in weekly average of daily Sleep Disturbance-Numerical Rating Scale (SD-NRS) from baseline [ Time Frame: Baseline to EOS (Week 176) ]
    The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD, with 0 being 'no sleep loss related to the symptoms of atopic dermatitis' and 10 being 'I did not sleep at all' due to the symptoms of atopic dermatitis".
17. Proportion of participants with a reduction in weekly average of daily SD-NRS ≥2 from baseline in participants with Baseline weekly average of daily SDNRS ≥2 [ Time Frame: Baseline to EOS (Week 176) ]
    The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD, with 0 being 'no sleep loss related to the symptoms of atopic dermatitis' and 10 being 'I did not sleep at all' due to the symptoms of atopic dermatitis".
18. Change in Patient Oriented Eczema Measure (POEM) from baseline [ Time Frame: Baseline to EOS (Week 176) ]
    The POEM is a 7-item self-assessment questionnaire used for monitoring atopic eczema severity, focusing on the signs and symptoms as experienced by the patient during the past 7 days. Total score ranges from 0 to 28.
19. Proportion of participants with a reduction in POEM ≥4 from Baseline in participants with POEM baseline ≥4 [ Time Frame: Baseline to EOS (Week 176) ]
    The POEM is a 7-item self-assessment questionnaire used for monitoring atopic eczema severity, focusing on the signs and symptoms as experienced by the patient during the past 7 days. Total score ranges from 0 to 28.
20. Proportion of adolescent participants with a reduction in POEM ≥6 from Baseline in adolescents participants with POEM baseline ≥6 [ Time Frame: Baseline to EOS (Week 176) ]
    The POEM is a 7-item self-assessment questionnaire used for monitoring atopic eczema severity, focusing on the signs and symptoms as experienced by the patient during the past 7 days. Total score ranges from 0 to 28.
21. Change in Atopic Dermatitis Control Test (ADCT) from baseline [ Time Frame: Baseline to EOS (Week 176) ]
    The ADCT is a 6-item patient-reported outcomes instrument with a 7-day recall period to measure AD disease control. Total score ranges from 0 to 24.
22. Proportion of participants with a reduction in ADCT ≥5 from baseline in participants with baseline ADCT≥5 [ Time Frame: Baseline to EOS (Week 176) ]
    The ADCT is a 6-item patient-reported outcomes instrument with a 7-day recall period to measure AD disease control. Total score ranges from 0 to 24.
23. Change in Dermatology Quality of Life Index (DLQI) from baseline in participants with age ≥16 years old [ Time Frame: Baseline to EOS (Week 176) ]
    The DLQI is a 10-item questionnaire to measure dermatology specific quality of life (QoL), covering the participant's previous week (i.e. past 7 days). Total score ranges from 0 to 30, with higher scores indicating greater detrimental impact on QoL.
24. Change in Children's Dermatology Life Quality Index (CDLQI) from baseline in participants with age ≥12 to <16 years old [ Time Frame: Baseline to EOS (Week 176) ]
    The CDLQI is a 10-item questionnaire to assess the impact of skin disease on a child's health related quality of life (HRQoL) over a recall period of 1 week. It is validated in children aged 4 to <16 years. Total score ranges from 0 to 30, with higher scores indicating greater detrimental impact on QoL.
25. Proportion of participants with age ≥12 to <16 with a reduction in CDLQI ≥4 from Baseline in participants with age ≥12 to <16 with CDLQI at baseline ≥4 [ Time Frame: Baseline to EOS (Week 176) ]
    The CDLQI is a 10-item questionnaire to assess the impact of skin disease on a child's health related quality of life (HRQoL) over a recall period of 1 week. It is validated in children aged 4 to <16 years. Total score ranges from 0 to 30, with higher scores indicating greater detrimental impact on QoL.
26. Proportion of participants with a reduction in DLQI ≥4 from Baseline in participants with age ≥16 years old and with DLQI at baseline ≥4 [ Time Frame: Baseline to EOS (Week 176) ]
    The DLQI is a 10-item questionnaire to measure dermatology specific quality of life (QoL), covering the participant's previous week (i.e. past 7 days). Total score ranges from 0 to 30, with higher scores indicating greater detrimental impact on QoL.
27. Change in Patient Global Impression of Severity (PGIS) from baseline [ Time Frame: Baseline to EOS (Week 176) ]
    The PGIS is a single item tool used to assess current severity of eczema symptoms, scored on a 5-point scale from 1 = no symptoms to 5 = very severe symptoms.
28. Proportions of participants who report symptoms to be "No" on the PGIS score [ Time Frame: Baseline to EOS (Week 176) ]
    The PGIS is a single item tool used to assess current severity of eczema symptoms, scored on a 5-point scale from 1 = no symptoms to 5 = very severe symptoms.
29. Proportions of participants who report symptoms to be "No" or "Mild" on the PGIS score [ Time Frame: Baseline to EOS (Week 176) ]
    The PGIS is a single item tool used to assess current severity of eczema symptoms, scored on a 5-point scale from 1 = no symptoms to 5 = very severe symptoms.
30. Proportion of participants who respond "Much better" on the Patient Global Impression of (PGIC) scale [ Time Frame: Week 16 to EOS (Week 176) ]
    The PGIC is a single item global tool used in the assessment of AD, scored on a 5-point scale from 1 = Much improved to 5 = Much worse.
31. Proportion of participants who respond "Much better" or "A little better" on the PGIC scale [ Time Frame: Week 16 to EOS (Week 176) ]
    The PGIC is a single item global tool used in the assessment of AD, scored on a 5-point scale from 1 = Much improved to 5 = Much worse.
32. Proportion of participants by PGIC responses [ Time Frame: Week 16 to EOS (Week 176) ]
    The PGIC is a single item global tool used in the assessment of AD, scored on a 5-point scale from 1 = Much improved to 5 = Much worse.
33. Change in Hospital Anxiety Depression Scale (HADS) from baseline [ Time Frame: Baseline to EOS (Week 176) ]
    The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week. It is comprised of 7 items assessing anxiety and depression respectively. A Total score is out of 42 (21 per subscale). Higher scores indicate greater levels of anxiety and/or depression.
34. Proportion of participants with HADS subscale Anxiety (HADS-A) <8 in participants with baseline HADS-A ≥8 [ Time Frame: Baseline to EOS (Week 176) ]

    The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week. It is comprised of 7 items assessing anxiety and depression respectively. A Total score is out of 42 (21 per subscale). Higher scores indicate greater levels of anxiety and/or depression.

    HADS-A is the anxiety HADS subscale.

35. Proportion of participants with HADS subscale Depression (HADS-D) <8 in participants with HADS-D Baseline ≥8 [ Time Frame: Baseline to EOS (Week 176) ]

    The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week. It is comprised of 7 items assessing anxiety and depression respectively. A Total score is out of 42 (21 per subscale). Higher scores indicate greater levels of anxiety and/or depression.

    HADS-D is the depression HADS subscale.

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Participant must be at least 12 years of age inclusive, at the time of signing the informed consent.
• Participants must have AD as defined by the American Academy of Dermatology Consensus Criteria for 1 year or longer at baseline.
• Participant must have documented history within 6 months prior to screening visit, of either inadequate response or inadvisability of topical treatments.
• Eczema Area Severity Index (EASI) of 16 or higher at baseline visit/Visit 2.
• Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) of 3 or 4 at baseline visit/Visit 2.
• AD involvement of 10% or more of body surface area (BSA) at baseline visit/Visit 2.
• Weekly average of daily Peak Pruritus-Numerical Rating Scale (PP-NRS) of ≥ 4 at baseline visit/Visit 2.
• Able and willing to comply with requested study visits and procedures.
• Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants must not be pregnant or breastfeeding.

Exclusion Criteria:

• Skin co-morbidity that would adversely affect the ability to undertake AD assessments as per investigator's judgement
• Known history of or suspected significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
• Any malignancies or history of malignancies prior to baseline (except for non-melanoma skin cancer that has been excised and completely cured for more than 5 years prior to baseline).
• History of solid organ or stem cell transplant.
• Any pre-planned major elective surgery known about at baseline that in the opinion of the investigator would necessitate that IMP be permanently discontinued or require more than three doses to be missed.
• Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study.
• Any medical or psychiatric condition which, in the opinion of the Investigator may present an unreasonable risk to the study participants as a result of his/her participation in this clinical study, may make participant's participation unreliable, or may interfere with study assessments.
• Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline (1 week in the event of superficial skin infections); and any infection (including confirmed Covid-19 infection at screening or baseline) which as per Investigator's opinion precludes the participant's participation in the study.
• Treatment with live (attenuated) vaccines within 12 weeks prior to baseline; failure to complete non-live immunizations required by local regulation (eg, vaccination for COVID-19) at least 14 days prior to baseline.
• Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit.
• Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C at the screening visit.
• Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, non-TB mycobacterial infection, or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening.
• In the Investigator's opinion, any clinically significant laboratory results from the clinical chemistry, haematology or urinalysis tests at the screening visit.
• In the Investigator's opinion, any significant abnormality on 12-lead electrocardiogram (ECG) at the screening visit that could be suggestive of an unstable or underlying cardio-vascular condition that could preclude the participant's participation in the study.
• History of hypersensitivity or allergy to any of the excipients or IMP or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Contacts and Locations

Contacts

Contact: Trial Transparency email recommended (Toll free number for US & Canada); 800-633-1610 ext option 6; Contact-US@sanofi.com

Locations

Argentina

Investigational Site Number : 0320008; Recruiting

Caba, Buenos Aires, Argentina, C1023AAB

Investigational Site Number : 0320003; Recruiting

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1181ACH

Investigational Site Number : 0320009; Recruiting

Caba, Ciudad De Buenos Aires, Argentina, C1425DKG

Investigational Site Number : 0320005; Recruiting

Caba, Ciudad De Buenos Aires, Argentina, C1430EGF

Investigational Site Number : 0320006; Recruiting

Rosario, Santa Fe, Argentina, S2000DBS

Investigational Site Number : 0320007; Recruiting

Rosario, Santa Fe, Argentina, S2000DEJ

Investigational Site Number : 0320004; Recruiting

Buenos Aires, Argentina, C1061AAA

Investigational Site Number : 0320001; Recruiting

Buenos Aires, Argentina, C1121ABE

Investigational Site Number : 0320002; Recruiting

Ciudad Autonoma Buenos Aires, Argentina, C1425BEN

Brazil

Instituto Bahiano de Imunoterapia - IBIS Site Number : 0760002; Recruiting

Salvador, Bahia, Brazil, 41820-020

Irmandade da Santa Casa de Misericordia de Porto Alegre Site Number : 0760005; Recruiting

Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090

Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo (HCFMRP-USP) Site Number : 0760008; Recruiting

Ribeirao Preto, São Paulo, Brazil, 14051-140

FUNDACAO DO ABC - FACULDADE DE MEDICINA DO ABC (FMABC) Site Number : 0760001; Recruiting

Santo Andre, São Paulo, Brazil, 09060-870

Hospital de Base Sao Jose do Rio Preto Site Number : 0760003; Recruiting

Sao Jose do Rio Preto, São Paulo, Brazil, 15090-000

Clinica de Alergia Martti Antila Site Number : 0760006; Recruiting

Sorocaba, São Paulo, Brazil, 18040-425

IDERJ - Instituto de Dermatologia e Estética do Brasil Ltda Site Number : 0760004; Recruiting

Rio de Janeiro, Brazil, 22470-220

Canada, Alberta

Investigational Site Number : 1240001; Recruiting

Calgary, Alberta, Canada, T2G 1B1

Canada, Ontario

Investigational Site Number : 1240009; Recruiting

Etobicoke, Ontario, Canada, M8X 1Y9

Investigational Site Number : 1240008; Recruiting

Mississauga, Ontario, Canada, L4Y 4C5

Investigational Site Number : 1240011; Recruiting

Oakville, Ontario, Canada, L6J 7W5

Investigational Site Number : 1240004; Recruiting

Peterborough, Ontario, Canada, K9J5K2

Investigational Site Number : 1240012; Recruiting

Toronto, Ontario, Canada, M3H 5Y8

Canada, Quebec

Investigational Site Number : 1240002; Recruiting

Montreal, Quebec, Canada, H3Z 2S6

Canada

Investigational Site Number : 1240010; Recruiting

Quebec, Canada, G1V 4X7

Investigational Site Number : 1240006; Recruiting

Quebec, Canada, G1W 4R4

Investigational Site Number : 1240003; Recruiting

Richmond Hill, Canada, L4C 9M7

Chile

Investigational Site Number : 1520009; Recruiting

Osorno, Los Lagos, Chile, 5310644

Investigational Site Number : 1520004; Recruiting

Valdivia, Los Ríos, Chile, 5110683

Investigational Site Number : 1520008; Recruiting

Santiago, Reg Metropolitana De Santiago, Chile, 7500588

Investigational Site Number : 1520002; Recruiting

Santiago, Reg Metropolitana De Santiago, Chile, 7580206

Investigational Site Number : 1520003; Recruiting

Santiago, Reg Metropolitana De Santiago, Chile, 7640881

Investigational Site Number : 1520010; Recruiting

Santiago, Reg Metropolitana De Santiago, Chile, 8330034

Investigational Site Number : 1520005; Recruiting

Santiago, Reg Metropolitana De Santiago, Chile, 8380465

Investigational Site Number : 1520001; Recruiting

Santiago, Reg Metropolitana De Santiago, Chile, 8420383

China

Investigational Site Number : 1560014; Recruiting

Chengdu, China, 610017

Investigational Site Number : 1560013; Recruiting

Jingzhou, China, 434020

Investigational Site Number : 1560001; Recruiting

Shanghai, China, 200040

Czechia

Investigational Site Number : 2032105; Recruiting

Novy Jicin, Czechia, 741 00

Investigational Site Number : 2032104; Recruiting

Ostrava, Czechia, 702 00

Investigational Site Number : 2032102; Recruiting

Praha 10, Czechia, 10000

Investigational Site Number : 2030003; Recruiting

Praha 10, Czechia, 10034

Investigational Site Number : 2030006; Recruiting

Praha 6, Czechia, 160 00

Investigational Site Number : 2030007; Recruiting

Praha 8, Czechia, 180 81

Denmark

Investigational Site Number : 2080001; Recruiting

Aarhus, Denmark, 8200

France

Investigational Site Number : 2500004; Recruiting

Creteil, France, 94000

Investigational Site Number : 2500001; Recruiting

Lille, France, 59037

Investigational Site Number : 2500005; Recruiting

Marseille, France, 13385

Investigational Site Number : 2500003; Recruiting

Paris, France, 75010

Investigational Site Number : 2500006; Recruiting

Pierre Benite, France, 69495

Investigational Site Number : 2500002; Recruiting

Toulouse, France, 31059

Germany

Investigational Site Number : 2760009; Recruiting

Bad Bentheim, Germany, 48455

Investigational Site Number : 2762203; Recruiting

Berlin, Germany, 10117

Investigational Site Number : 2762201; Recruiting

Münster, Germany, 48149

Investigational Site Number : 2760010; Recruiting

Osnabrück, Germany, 49074

India

Investigational Site Number : 3560007; Recruiting

Bikaner, India, 334001

Investigational Site Number : 3560002; Recruiting

Nashik, India, 422101

Investigational Site Number : 3560008; Recruiting

Surat, India, 395002

Italy

Investigational Site Number : 3800003; Recruiting

Milano, Lombardia, Italy, 20122

Investigational Site Number : 3800005; Recruiting

Brescia, Italy, 25123

Investigational Site Number : 3800002; Recruiting

Napoli, Italy, 80131

Investigational Site Number : 3800004; Recruiting

Napoli, Italy, 80131

Investigational Site Number : 3800007; Recruiting

Roma, Italy, 00161

Investigational Site Number : 3800006; Recruiting

Roma, Italy, 00168

Japan

Investigational Site Number : 3923114; Recruiting

Obihiro-Shi, Hokkaido, Japan, 080-0013

Investigational Site Number : 3923113; Recruiting

Yokohama-Shi, Kanagawa, Japan, 221-0825

Investigational Site Number : 3923110; Recruiting

Sakai-shi, Osaka, Japan, 593-8324

Investigational Site Number : 3923106; Recruiting

Shimotsuga-gun, Tochigi, Japan, 321-0293

Investigational Site Number : 3920001; Recruiting

Tachikawa-shi, Tokyo, Japan, 190-0023

Korea, Republic of

Investigational Site Number : 4100002; Recruiting

Ansan-si, Gyeonggi-do, Korea, Republic of, 15355

Investigational Site Number : 4100003; Recruiting

Yangsan-si, Gyeongsangnam-do, Korea, Republic of

Investigational Site Number : 4100006; Recruiting

Seoul, Seoul-teukbyeolsi, Korea, Republic of, 05030

Investigational Site Number : 4100001; Recruiting

Seoul, Korea, Republic of, 07441

Mexico

Investigational Site Number : 4840007; Active, not recruiting

Benito Juarez, Ciudad De Mexico, Mexico, 03100

Netherlands

Investigational Site Number : 5280002; Recruiting

Breda, Netherlands, 4818 CK

Investigational Site Number : 5280004; Recruiting

Rotterdam, Netherlands, 3015 GD

Investigational Site Number : 5280001; Recruiting

Utrecht, Netherlands, 3508 GA

Poland

Investigational Site Number : 6160006; Recruiting

Gdansk, Pomorskie, Poland, 80-546

Investigational Site Number : 6160003; Recruiting

Katowice, Slaskie, Poland, 40-611

Investigational Site Number : 6160001; Recruiting

Chorzow, Poland, 41516

Investigational Site Number : 6160007; Recruiting

Warszawa, Poland, 02-962

Investigational Site Number : 6160009; Recruiting

Warszawa, Poland, 02625

South Africa

Investigational Site Number : 7100010; Recruiting

Cape Town, South Africa, 7530

Investigational Site Number : 7100011; Recruiting

Cape Town, South Africa, 7530

Investigational Site Number : 7100002; Recruiting

Cape Town, South Africa, 7937

Investigational Site Number : 7100009; Recruiting

Claremont, South Africa, 7708

Investigational Site Number : 7100012; Recruiting

Durban, South Africa, 3630

Investigational Site Number : 7100008; Recruiting

Johannesburg, South Africa, 2013

Investigational Site Number : 7100006; Recruiting

Kempton Park, South Africa, 1619

Investigational Site Number : 7100005; Recruiting

Middelburg, South Africa, 1055

Investigational Site Number : 7100003; Recruiting

Pretoria, South Africa, 0145

Investigational Site Number : 7100014; Recruiting

Pretoria, South Africa, 0157

Investigational Site Number : 7100004; Recruiting

Reiger Park, South Africa, 1459

Investigational Site Number : 7100007; Recruiting

Sandton, South Africa, 2196

Spain

Investigational Site Number : 7240002; Recruiting

Badalona, Catalunya [Cataluña], Spain, 08916

Investigational Site Number : 7242503; Recruiting

Madrid, Madrid, Comunidad De, Spain, 28046

Investigational Site Number : 7242505; Recruiting

Alicante, Spain, 03010

Investigational Site Number : 7242501; Recruiting

Córdoba, Spain, 14004

Investigational Site Number : 7240006; Recruiting

Valencia, Spain, 46026

Taiwan

Investigational Site Number : 1583201; Recruiting

Kaohsiung 833, Taiwan, 833

Investigational Site Number : 1580002; Recruiting

New Taipei City, Taiwan, 23561

Investigational Site Number : 1583202; Recruiting

Taichung, Taiwan, 40201

Investigational Site Number : 1580001; Recruiting

Taipei, Taiwan, 10002

Investigational Site Number : 1583203; Recruiting

Taoyuan County, Taiwan, 33305

United Kingdom

Investigational Site Number : 8260001; Recruiting

London, London, City Of, United Kingdom, NW3 2QG

Investigational Site Number : 8262601; Recruiting

London, London, City Of, United Kingdom, SE1 9RT

Investigational Site Number : 8260002; Recruiting

Edinburgh, United Kingdom, EH8 9RS

Sponsors and Collaborators

Sanofi

Investigators

• Study Director: Clinical Sciences & Operations; Sanofi

More Information

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT05769777
• Other Study ID Numbers: LTS17789; U1111-1280-6080 ( Other Identifier: ICTRP ); 2022-502188-39 ( Registry Identifier: CTIS )
• First Posted: March 15, 2023
• Last Update Posted: May 10, 2024
• Last Verified: May 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases