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RecruitingNCT05263206Updated Oct 15, 2026

Efficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC)

A Phase 3 interventional study of Dupilumab and Placebo in Pruritus, sponsored by Sanofi. Recruiting at 94 sites in 13 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Sanofi · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2022; still recruiting 4 years 8 months later.
Updated Oct 15, 20266 sites added5 sites removedGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
284
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

The main objective of the study is to assess efficacy and safety of dupilumab given up to 24 weeks in adults with CPUO.

This is a master protocol which includes 2 parallel-treatment, double-blind, 2- arm Phase 3 staggered studies of similar design (Study A and Study B) in male and female participants aged 18 to 90 years with CPUO. Study B design was to be adapted based on the results of Study A.

For both Study A and B, after an up-to-4-week screening period, participants with severe pruritus (worst-itch numerical rating scale [WI-NRS ≥7) will enter a 4-week run-in period and will be treated with a non-sedative antihistamine and an emollient (moisturizer). Participants with severe pruritus (WI-NRS ≥7) at baseline will be randomized (1:1) to be treated for 24 weeks with either dupilumab or matching placebo in addition to their non-sedative antihistamine and emollient regimen. The treatment period for both study A and B will be followed by a 12-week follow-up period.

Read the detailed description

Study duration per participant will be up to 44 weeks for both Study A and Study B.

02

Conditions studied

  • Pruritus

Browse trials for

03

In context

Pruritus

490 studies on the registry are indexed under Pruritus; 93 are open to participants now.

This study's planned enrollment of 284 is above the median of 60 across 422 interventional studies indexed under Pruritus.

Browse Pruritus studies →

Lead sponsor

Sanofi is the lead sponsor of 1,557 studies on the registry; 91 are open to participants now.

Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.

Browse Sanofi studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 90 years of age inclusive, at the time of signing the .
  • Participants with chronic pruritus for at least 6 months before the screening visit.
  • Chronic pruritus considered of unknown origin as assessed by the investigator at baseline (excluding chronic pruritus secondary to dermatological or systemic conditions, of neuropathic or psychogenic origin or secondary to drugs).
  • Chronic pruritus must affect at least 2 of the following body areas: legs, arms, or trunk.
  • History of insufficient control of the chronic pruritus with prior treatment.
  • Participants should receive optimal treatment for concomitant conditions that could impact pruritus (eg, diabetes, iron deficiency).
  • Participants must have a history of severe itch and a worst itch score of ≥7 at screening on the WI-NRS (score scale ranges from 0 to 10; higher score indicates worse itch) and Patient Global Impression of Severity (PGIS) of pruritus scored "severe" at screening.
  • Participants must have an average worst itch score of ≥7 in the 7 days prior to run-in visit and in the 7 days prior to Day 1 on the WI-NRS.
  • Participants scored "severe" in the PGIS of pruritus on Day 1.

Exclusion criteria

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the patient's participation in the study.
  • Patients with active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis, unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent.
  • Diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drug within 2 weeks before the screening visit.
  • infection.
  • Severe renal failure (dialysis).
  • Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the run-in visit.
  • Known or suspected immunodeficiency.
  • Active or history of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix and completely treated and resolved non squamous or basal cell carcinoma of the skin.
  • History of or intolerance to non-sedative antihistamines.
  • Participation in prior dupilumab clinical study or have been treated with commercially available dupilumab.

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

Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
284 participants (estimated)

Study arms

  • Experimental
    Dupilumab

    Loading dose administered subcutaneous (SC), followed by SC once every 2 weeks (Q2W) on top of non-sedative antihistamine and moisturizer

    Drug: Dupilumab · Drug: Fexofenadine (loratadine if not available)

  • Placebo comparator
    Placebo

    Loading dose administered SC, followed by SC Q2W on top of non-sedative antihistamine and moisturizer

    Drug: Placebo · Drug: Fexofenadine (loratadine if not available)

Interventions

06

What researchers measure

Primary outcomes

  1. Study A: Proportion of participants with improvement (reduction) in weekly average of daily worst-itch numerical rating scale (WI-NRS) by ≥4 from baseline to Week 24

    WI-NRS is a patient reported outcome (PRO) comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

    Time frame: Baseline to Week 24

  2. Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12

    WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

    Time frame: Baseline to Week 12

Secondary outcomes

  1. Study A; Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12

    WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

    Time frame: Baseline to Week 12

  2. Study A: Proportion of participants who scored "none" or "mild" in Patient Global Impression of Severity (PGIS) of pruritus at Week 24

    The PGIS of pruritus is a one-item categorical scale that asks participants to provide the overall self-assessment of their pruritus severity on a 4-point scale for the past week. Response choices are: "None", "Mild", "Moderate", "Severe".

    Time frame: Week 24

  3. Study A: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline over time until Week 24

    WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

    Time frame: Baseline to Week 24

  4. Study A: Time to first response of WI-NRS ≥4 points reduction from baseline by Week 24

    WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

    Time frame: Baseline to Week 24

  5. Study A: Absolute change from baseline in weekly average of daily WI-NRS at Week 24

    WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

    Time frame: Baseline to Week 24

  6. Study A: Percent change from baseline in weekly average of daily WI-NRS at Week 24

    WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

    Time frame: Baseline to Week 24

  7. Study A: Proportion of participants who scored "none" or "mild" in PGIS of pruritus at Week 12

    The PGIS of pruritus is a one-item categorical scale that asks participants to provide the overall self-assessment of their pruritus severity on a 4-point scale for the past week. Response choices are: "None", "Mild", "Moderate", "Severe".

    Time frame: Week 12

  8. Study A: Absolute change from baseline in weekly average of daily WI-NRS at Week 12

    WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

    Time frame: Baseline to Week 12

  9. Study A: Percent change from baseline in weekly average of daily WI-NRS at Week 12

    WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

    Time frame: Baseline to Week 12

  10. Study A: Absolute change from baseline in weekly average of daily sleep disturbance numerical rating scale (NRS) at Week 24

    The sleep disturbance NRS is to be used by the participants to report the degree of their sleep loss related to itch over the past 24 hours. Participants will rate their sleep disturbance from 0 ('no sleep loss related to itch') to 10 ('I cannot sleep at all due to itch') once daily in the morning.

    Time frame: Baseline to Week 24

  11. Study A: Percent change from baseline in weekly average of daily sleep disturbance NRS at Week 24

    The sleep disturbance NRS is to be used by the participants to report the degree of their sleep loss related to itch over the past 24 hours. Participants will rate their sleep disturbance from 0 ('no sleep loss related to itch') to 10 ('I cannot sleep at all due to itch') once daily in the morning.

    Time frame: Baseline to Week 24

  12. Study A: Change from baseline in Dermatology Life Quality Index (DLQI) score at Week 24

    The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.

    Time frame: Baseline to Week 24

  13. Study A: Change from baseline in the Itchy quality of life (ItchyQoL) score at Week 24

    ItchyQoL is a pruritus-specific QoL instrument that measures specifically disease burden in pruritus patients.

    Time frame: Baseline to Week 24

  14. Study A: Change from baseline in Hospital Anxiety and Depression Scale (HADS) total score at Week 24

    The HADS is a validated questionnaire for screening anxiety and depression in non-psychiatric populations. The total score ranges from 0 to 42. 0 to 7= normal; 8 to 10= borderline abnormal; 11 to 21= abnormal.

    Time frame: Baseline to Week 24

  15. Study A: Absolute change from baseline in weekly average of daily sleep disturbance NRS at Week 12

    The sleep disturbance NRS is to be used by the participants to report the degree of their sleep loss related to itch over the past 24 hours. Participants will rate their sleep disturbance from 0 ('no sleep loss related to itch') to 10 ('I cannot sleep at all due to itch') once daily in the morning.

    Time frame: Baseline to Week 12

  16. Study A: Percent change from baseline in weekly average of daily sleep disturbance NRS at Week 12

    The sleep disturbance NRS is to be used by the participants to report the degree of their sleep loss related to itch over the past 24 hours. Participants will rate their sleep disturbance from 0 ('no sleep loss related to itch') to 10 ('I cannot sleep at all due to itch') once daily in the morning.

    Time frame: Baseline to Week 12

  17. Study A: Change from baseline in DLQI score at Week 12

    The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.

    Time frame: Baseline to Week 12

  18. Study A: Change from baseline in the ItchyQoL score at Week 12

    ItchyQoL is a pruritus-specific QoL instrument that measures specifically disease burden in pruritus patients. It is a 22-item instrument that measures the degree to which pruritus affects quality-of-life for the past week. The overall score is the average of the 22 items ranging from 1 to 5. A higher score corresponds to a more adverse impact on QoL.

    Time frame: Baseline to Week 12

  19. Study A: Change from baseline in HADS total score at Week 12

    The HADS is a validated questionnaire for screening anxiety and depression in non-psychiatric populations. The total score ranges from 0 to 42. 0 to 7= normal; 8 to 10= borderline abnormal; 11 to 21= abnormal.

    Time frame: Baseline to Week 12

  20. Study A: Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) from baseline through end of study (EOS)

    Percentage of participants experiencing TEAEs or SAEs from baseline through EOS

    Time frame: Baseline to Week 36

  21. Study A: Incidence of treatment-emergent antidrug antibodies (ADA) against dupilumab

    Incidence of treatment-emergent ADA against dupilumab

    Time frame: Baseline to Week 36

  22. Study B: Proportion of participants who scored "none" or "mild" in PGIS of pruritus at Week 24

    The PGIS of pruritus is a one-item categorical scale that asks participants to provide the overall self-assessment of their pruritus severity on a 4-point scale for the past week. Response choices are: "None", "Mild", "Moderate", "Severe".

    Time frame: Week 24

  23. Study B: Proportion of participants who scored "none" or "mild" in PGIS of pruritus at Week 12

    The PGIS of pruritus is a one-item categorical scale that asks participants to provide the overall self-assessment of their pruritus severity on a 4-point scale for the past week. Response choices are: "None", "Mild", "Moderate", "Severe".

    Time frame: Week 12

  24. Study B: Absolute change from baseline in weekly average of daily WI-NRS at Week 12

    WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

    Time frame: Baseline to Week 12

  25. Study B: Percent change from baseline in weekly average of daily WI-NRS at Week 12

    WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

    Time frame: Baseline to Week 12

  26. Study B: Absolute change from baseline in weekly average of daily WI-NRS at Week 24

    WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

    Time frame: Baseline to Week 24

  27. Study B: Percentage change from baseline in weekly average of daily WI-NRS at Week 24

    WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

    Time frame: Baseline to Week 24

  28. Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline, sustained from Week 19 through Week 24

    WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

    Time frame: Baseline to Week 19 through Week 24

  29. Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥5 from baseline to Week 24

    WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

    Time frame: Baseline to Week 24

  30. Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24

    WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

    Time frame: Baseline to Week 24

  31. Study B: Proportion of participants with weekly average of daily WI-NRS <2 at Week 24

    WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

    Time frame: Week 24

  32. Study B: Time to first response of WI-NRS ≥4 points reduction from baseline by Week 24

    WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

    Time frame: Baseline to Week 24

  33. Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥5 from baseline to Week 12

    WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

    Time frame: Baseline to Week 12

  34. Study B: Proportion of participants with weekly average of daily WI-NRS <2 at Week 12

    WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

    Time frame: Week 12

  35. Study B: Absolute change from baseline in weekly average of daily itch-related sleep disturbance NRS at Week 12 and Week 24

    The sleep disturbance NRS is to be used by the participants to report the degree of their sleep loss related to itch over the past 24 hours. Participants will rate their sleep disturbance from 0 ('no sleep loss related to itch') to 10 ('I cannot sleep at all due to itch') once daily in the morning.

    Time frame: Baseline to Week 12 and Week 24

  36. Study B: Percent change from baseline in weekly average of daily itch-related sleep disturbance NRS at Week 12 and Week 24

    The sleep disturbance NRS is to be used by the participants to report the degree of their sleep loss related to itch over the past 24 hours. Participants will rate their sleep disturbance from 0 ('no sleep loss related to itch') to 10 ('I cannot sleep at all due to itch') once daily in the morning.

    Time frame: Baseline to Week 12 and Week 24

  37. Study B: Change from baseline in DLQI score at Week 12 and Week 24

    The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.

    Time frame: Baseline to Week 12 and Week 24

  38. Study B: Change from baseline in the ItchyQoL score at Week 12 and Week 24

    ItchyQoL is a pruritus-specific QoL instrument that measures specifically disease burden in pruritus patients. It is a 22-item instrument that measures the degree to which pruritus affects quality-of-life for the past week. The overall score is the average of the 22 items ranging from 1 to 5. A higher score corresponds to a more adverse impact on QoL.

    Time frame: Baseline to Week 12 and Week 24

  39. Study B: Change from baseline in HADS total score at Week 12 and Week 24

    The HADS is a validated questionnaire for screening anxiety and depression in non-psychiatric populations. The total score ranges from 0 to 42. 0 to 7= normal; 8 to 10= borderline abnormal; 11 to 21= abnormal.

    Time frame: Baseline to Week 12 and Week 24

  40. Study B: Percentage of participants experiencing TEAEs or SAEs from baseline through EOS

    Percentage of participants experiencing TEAEs or SAEs from baseline through EOS

    Time frame: Baseline to Week 36

  41. Study B: Incidence of treatment-emergent ADA against dupilumab

    Incidence of treatment-emergent ADA against dupilumab

    Time frame: Baseline to Week 36

07

Study locations

81 of 94 sites recruiting
  • Kern Allergy and Medical Research- Site Number : 8400016
    Bakersfield, California 93301, United States
    Completed

    Not enrolling at this site — choose another above.

  • Modena Allergy + Asthma- Site Number : 8400038
    La Jolla, California 92037, United States
    Recruiting
  • FoxHall Dermatology- Site Number : 8400042
    Washington D.C., District of Columbia 20016, United States
    Recruiting
  • Palm Harbor Dermatology- Site Number : 8400024
    Belleair, Florida 32756, United States
    Recruiting
  • University of Miami Hospital- Site Number : 8400011
    Miami, Florida 33136, United States
    Recruiting
  • Skin Care Physicians of Georgia - Macon- Site Number : 8400030
    Macon, Georgia 31217, United States
    Recruiting
  • Aeroallergy Research Laboratory- Site Number : 8400036
    Savannah, Georgia 31406, United States
    Recruiting
  • Treasure Valley Medical Research- Site Number : 8400049
    Boise, Idaho 83706, United States
    Recruiting
  • Dawes Fretzin Clinical Research- Site Number : 8400007
    Indianapolis, Indiana 46250, United States
    Recruiting
  • Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400031
    Louisville, Kentucky 40241, United States
    Recruiting
  • Tulane University School of Medicine- Site Number : 8400045
    New Orleans, Louisiana 70112, United States
    Recruiting
  • Johns Hopkins Hospital- Site Number : 8400020
    Baltimore, Maryland 21287, United States
    Recruiting
  • The Asthma and Allergy Center- Site Number : 8400014
    Bellevue, Nebraska 68123, United States
    Recruiting
  • Mount Sinai - Union Square- Site Number : 8400034
    New York, New York 10003, United States
    Recruiting
  • AXIS Clinicals - Fargo- Site Number : 8400037
    Fargo, North Dakota 58103, United States
    Recruiting
  • Optima Research - Boardman- Site Number : 8400039
    Boardman, Ohio 44512, United States
    Recruiting
  • Columbia Dermatology & Aesthetics- Site Number : 8400047
    Columbia, South Carolina 29212, United States
    Recruiting
  • National Allergy and Asthma Research- Site Number : 8400032
    North Charleston, South Carolina 29420, United States
    Recruiting
  • Complete Dermatology - Site Number : 8400046
    Sugar Land, Texas 77479, United States
    Recruiting
  • Investigational Site Number : 0320004
    Rosario, Santa Fe Province 2000, Argentina
    Completed

    Not enrolling at this site — choose another above.

  • Investigational Site Number : 0320008
    Rosario, Santa Fe Province 2000, Argentina
    Recruiting
  • Investigational Site Number : 0320005
    Buenos Aires, 1012, Argentina
    Recruiting
  • Investigational Site Number : 0320001
    Buenos Aires, 1023, Argentina
    Completed

    Not enrolling at this site — choose another above.

  • Investigational Site Number : 0320006
    Buenos Aires, 1055, Argentina
    Recruiting
  • Investigational Site Number : 0320007
    Buenos Aires, 1061, Argentina
    Recruiting
  • Investigational Site Number : 0320002
    Buenos Aires, 1121, Argentina
    Recruiting
  • Investigational Site Number : 0320003
    Buenos Aires, 1414, Argentina
    Recruiting
  • Investigational Site Number : 1240001
    Calgary, Alberta T2G 1B1, Canada
    Recruiting
  • Investigational Site Number : 1240008
    Edmonton, Alberta T6G 1C3, Canada
    Completed

    Not enrolling at this site — choose another above.

  • Investigational Site Number : 1240002
    London, Ontario L6A 2C2, Canada
    Recruiting
  • Investigational Site Number : 1240003
    Markham, Ontario L3P 1X2, Canada
    Completed

    Not enrolling at this site — choose another above.

  • Investigational Site Number : 1240006
    Toronto, Ontario M4C 1L1, Canada
    Recruiting
  • Investigational Site Number : 1240005
    Montreal, Quebec H4A 3T2, Canada
    Completed

    Not enrolling at this site — choose another above.

  • Investigational Site Number : 1240004
    Verdun, Quebec H4G 2L8, Canada
    Recruiting
  • Investigational Site Number : 1560003
    Beijing, 100191, China
    Recruiting
  • Investigational Site Number : 1560004
    Chengdu, 610041, China
    Recruiting
  • Investigational Site Number : 1560009
    Chongqing, 400016, China
    Recruiting
  • Investigational Site Number : 1560006
    Guangzhou, 510018, China
    Recruiting
  • Investigational Site Number : 1560005
    Guangzhou, 510080, China
    Recruiting
  • Investigational Site Number : 1560002
    Hangzhou, 310006, China
    Recruiting
  • Investigational Site Number : 1560001
    Shanghai, 200040, China
    Recruiting
  • Investigational Site Number : 1560011
    Suzhou, 215006, China
    Recruiting
  • Investigational Site Number : 1560008
    Wuhan, 430022, China
    Recruiting
  • Investigational Site Number : 2500001
    Brest, 29200, France
    Recruiting
  • Investigational Site Number : 2500003
    Nice, 06202, France
    Recruiting
  • Investigational Site Number : 2500004
    Reims, 51100, France
    Recruiting
  • Investigational Site Number : 2760005
    Bad Bentheim, 48455, Germany
    Recruiting
  • Investigational Site Number : 2760002
    Berlin, 12203, Germany
    Recruiting
  • Investigational Site Number : 2760004
    Frankfurt, 60590, Germany
    Recruiting
  • Investigational Site Number : 2760003
    Mainz, 55131, Germany
    Recruiting
  • Investigational Site Number : 2760001
    Münster, 48149, Germany
    Recruiting
  • Investigational Site Number : 3480001
    Budapest, 1036, Hungary
    Recruiting
  • Investigational Site Number : 3480009
    Budapest, 1066, Hungary
    Recruiting
  • Investigational Site Number : 3480005
    Debrecen, 4031, Hungary
    Recruiting
  • Investigational Site Number : 3480010
    Gyula, 5700, Hungary
    Recruiting
  • Investigational Site Number : 3480003
    Szeged, 6720, Hungary
    Recruiting
  • Investigational Site Number : 3480011
    Székesfehérvár, 8000, Hungary
    Recruiting
  • Investigational Site Number : 3480002
    Zalaegerszeg, 8900, Hungary
    Recruiting
  • Azienda Ospedaliero-Universitaria di Ferrara-Site Number : 3800007
    Cona, Ferrara 44124, Italy
    Recruiting
  • AUSL Toscana Centro - Presidio Ospedaliero "Piero Palagi-"Site Number : 3800005
    Florence, Firenze 50125, Italy
    Recruiting
  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-Site Number : 3800003
    Milan, Milano 20122, Italy
    Recruiting
  • Investigational Site Number : 3800002
    Rozzano, Milano 20089, Italy
    Recruiting
  • Investigational Site Number : 3800006
    Naples, Napoli 80131, Italy
    Recruiting
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Site Number : 3800001
    Rome, Roma 00168, Italy
    Recruiting
  • Azienda Ospedaliero Universitaria delle Marche-Site Number : 3800004
    Ancona, 60126, Italy
    Recruiting
  • Investigational Site Number : 3920009
    Matsudo, Chiba 271-0092, Japan
    Recruiting
  • Investigational Site Number : 3920007
    Urayasu, Chiba 279-0011, Japan
    Recruiting
  • Investigational Site Number : 3920006
    Sapporo, Hokkaido 060-0063, Japan
    Recruiting
  • Investigational Site Number : 3920008
    Yokohama, Kanagawa 220-6208, Japan
    Recruiting
  • Investigational Site Number : 3920004
    Habikino, Osaka 583-8588, Japan
    Recruiting
  • Investigational Site Number : 3920002
    Sakai, Osaka 593-8324, Japan
    Recruiting
  • Investigational Site Number : 3920005
    Izumo, Shimane 693-8501, Japan
    Recruiting
  • Investigational Site Number : 3920001
    Tachikawa, Tokyo 190-0023, Japan
    Recruiting
  • Investigational Site Number : 6160001
    Krakow, Lesser Poland Voivodeship 30-033, Poland
    Recruiting
  • Investigational Site Number : 6160007
    Wroclaw, Lower Silesian Voivodeship 50-566, Poland
    Recruiting
  • Investigational Site Number : 6160003
    Wroclaw, Lower Silesian Voivodeship 51-318, Poland
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Investigational Site Number : 6160008
    Warsaw, Masovian Voivodeship 01-142, Poland
    Recruiting
  • Investigational Site Number : 6160005
    Warsaw, Masovian Voivodeship 02-172, Poland
    Recruiting
  • Investigational Site Number : 4100003
    Busan, Busan 49241, South Korea
    Completed

    Not enrolling at this site — choose another above.

  • Investigational Site Number : 4100004
    Ansan-si, Gyeonggi-do 15355, South Korea
    Completed

    Not enrolling at this site — choose another above.

  • Investigational Site Number : 4100005
    Seoul, Seoul-teukbyeolsi 03080, South Korea
    Completed

    Not enrolling at this site — choose another above.

  • Investigational Site Number : 4100002
    Seoul, Seoul-teukbyeolsi 03722, South Korea
    Completed

    Not enrolling at this site — choose another above.

  • Investigational Site Number : 4100006
    Seoul, Seoul-teukbyeolsi 05030, South Korea
    Recruiting
  • Investigational Site Number : 4100001
    Seoul, Seoul-teukbyeolsi 07441, South Korea
    Completed

    Not enrolling at this site — choose another above.

  • Investigational Site Number : 4100007
    Seoul, Seoul-teukbyeolsi 07804, South Korea
    Recruiting
  • Investigational Site Number : 7240003
    Barcelona, Catalunya [Cataluña] 08003, Spain
    Completed

    Not enrolling at this site — choose another above.

  • Investigational Site Number : 7240006
    Barcelona, Catalunya [Cataluña] 08041, Spain
    Recruiting
  • Investigational Site Number : 7240001
    Pontevedra, Pontevedra [Pontevedra] 36002, Spain
    Recruiting
  • Investigational Site Number : 7240005
    Alicante, 03010, Spain
    Recruiting
  • Investigational Site Number : 7240004
    Córdoba, 14004, Spain
    Recruiting
  • Investigational Site Number : 1580003
    Kaohsiung City, 833, Taiwan
    Recruiting
  • Investigational Site Number : 1580004
    New Taipei City, 235, Taiwan
    Recruiting
  • Investigational Site Number : 1580001
    Taipei, 100, Taiwan
    Recruiting
  • Investigational Site Number : 1580002
    Taoyuan City, 333, Taiwan
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — 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

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2022 (actual). Primary completion is estimated for Jun 2027, 63 months after the start.

Of 42 industry-sponsored phase 3 interventional studies under Pruritus, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 27. This study's planned 63 months is above that.

Counting every sponsor, half of 48 studies reached it within 19 months; a quarter within 12 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 22, 2022
First posted
Mar 2, 2022
StartActual
Feb 15, 2022
Primary completionEst.
Jun 2, 2027
CompletionEst.
Aug 25, 2027
Last update
Oct 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
6 sites added, 5 sites removed
Show 6 added (3 United States, 2 Japan, 1 Spain)
  • Treasure Valley Medical Research- Site Number : 8400049 · Boise, United States
  • National Allergy and Asthma Research- Site Number : 8400032 · North Charleston, United States
  • Complete Dermatology - Site Number : 8400046 · Sugar Land, United States
  • Investigational Site Number : 3920009 · Matsudo, Japan
  • Investigational Site Number : 3920008 · Yokohama, Japan
  • Investigational Site Number : 7240003 · Barcelona, Spain
Show 5 removed
  • National Allergy and Asthma - North Charleston - Northside Drive- Site Number : 8400032 · North Charleston, United States
  • Complete Dermatology - Sugar Land- Site Number : 8400046 · Sugar Land, United States
  • Investigational Site Number : 3920003 · Obihiro, Japan
  • Investigational Site Number : 6160003 · Wroclaw, Poland
  • Investigational Site Number : 7240003 · Barcelona, Spain
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    6 sites added, 5 sites removed
    Show 6 added (3 United States, 2 Japan, 1 Spain)
    • Treasure Valley Medical Research- Site Number : 8400049 · Boise, United States
    • National Allergy and Asthma Research- Site Number : 8400032 · North Charleston, United States
    • Complete Dermatology - Site Number : 8400046 · Sugar Land, United States
    • Investigational Site Number : 3920009 · Matsudo, Japan
    • Investigational Site Number : 3920008 · Yokohama, Japan
    • Investigational Site Number : 7240003 · Barcelona, Spain
    Show 5 removed
    • National Allergy and Asthma - North Charleston - Northside Drive- Site Number : 8400032 · North Charleston, United States
    • Complete Dermatology - Sugar Land- Site Number : 8400046 · Sugar Land, United States
    • Investigational Site Number : 3920003 · Obihiro, Japan
    • Investigational Site Number : 6160003 · Wroclaw, Poland
    • Investigational Site Number : 7240003 · Barcelona, Spain
    + 3 other changes: identifiers, verification date and references

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05263206
Lead sponsor
Sanofi
Responsible party
Sponsor
First posted
Mar 2, 2022
Start date
Feb 15, 2022
Primary completion
Jun 2, 2027 (estimated)
Completion
Aug 25, 2027 (estimated)
Last update
Oct 15, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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