Atopic DermatitisPhase 2NCT05018806
Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis
A Phase 2 study testing Rilzabrutinib in people with Atopic Dermatitis, run by Sanofi at 31 sites in 7 countries.
Trial summary
This was a parallel treatment, Phase 2, double-blind, 2-arm, placebo-controlled study with 2 staggered cohorts (2 arms in each cohort) to evaluate the efficacy and safety of rilzabrutinib in adult participants (aged at least 18 years) with moderate-to-severe AD and intolerance or inadequate response to topical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Rilzabrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 31 sitesin 7 countries
- Study dates
- 9 Sep 2021to 23 Jun 2023
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AD as defined by the American Academy of Dermatology Consensus Criteria.
- History of AD for at least 12 months prior to baseline as determined by the Investigator through patient interview.
- Eczema Area and Severity Index (EASI) score ≥ 12 at screening and at baseline.
- IGA score ≥ 3 (on the 0 to 4 IGA scale) at baseline.
- BSA of AD involvement ≥ 10% at baseline.
- Documented inadequate response or intolerance to TCS within 6 months prior to baseline visit
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- Baseline PP-NRS score for maximum itch intensity ≥4.
- All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- For optional substudy only: Willingness to have 2 tape strips for comparison of baseline and treatment response.
Who cannot join
- Skin comorbidities that may interfere with study assessments such as psoriasis, tinea corporis, lupus erythematosus.
- Conditions that may predispose the patient to excessive bleeding.
- Any other clinically significant disease, condition, or medical history that, in the opinion of the Investigator, would interfere with participant safety, trial evaluations, and/or trial procedures.
- Laboratory abnormalities at the screening visit
- History of serious infections requiring intravenous therapy with the potential for recurrence (as judged by the Site Investigator and the Sponsor Medical Monitor), with less than 4 weeks interval between resolution of serious infection and first dose of study drug, or currently active moderate to severe infection at Screening (Grade 2 or higher) including active coronavirus disease 2019 (COVID-19).
- Live vaccine except Bacille Calmette Guerin-vaccination within 28 days prior to Day 1 or plan to receive one during the trial; Bacille Calmette Guerin-vaccination within 12 months prior to Screening.
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- COVID-19 vaccine within 14 days prior to Study Day 1.
- Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate rilzabrutinib/placebo absorption.
- Initiation of prescription moisturizers (with or without additives such as ceramide, hyaluronic acid, urea, or filaggrin), topical anesthetics or antihistamines during the screening period.
- Use of TCS, topical calcineurin (tacrolimus, and/or pimecrolimus) or topical phosphodiesterase 4 inhibitor within 1 week prior to baseline and as concomitant medication.
- Use of systemic corticosteroids within 4 weeks prior to baseline and as concomitant medication.
- Phototherapy for AD or regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks prior to baseline or likely to be required as concomitant procedure during the study.
- Use of mycophenolate mofetil, azathioprine, methotrexate, cyclosporine, dapsone, intravenous immunoglobulin (IVIG), Kineret (anakinra), Enbrel (etanercept), or any other immunosuppressant not mentioned in this exclusion criterion within 4 weeks prior to baseline.
- Use of infliximab, adalimumab, golimumab, abatacept, tocilizumab, certolizumab, secukinumab, IFN-γ, JAK inhibitors, dupilumab, and any other biologic or targeted-synthetic disease modifier drug not mentioned in this exclusion criterion or in exclusion criterion, as well as plasmapheresis within 12 weeks prior to baseline.
- Use of anti-CD20 drugs such as rituximab, ofatumumab, other long-acting biologics within 6 months prior to baseline (or shorter if there is documented B cell reconstitution for anti-CD20 drugs).
- Use of proton pump inhibitor drugs such as omeprazole and esomeprazole within 3 days of baseline (it is acceptable to change participant to H2 receptor blocking drugs prior to baseline).
- Concomitant use of known systemic strong-to-moderate inhibitors and inducers of cytochrome P450 3A (CYP3A) within 14 days or 5 half-lives (whichever is longer) prior to baseline.
- Previous use of a BTK inhibitor.
- Had received any investigational drug (or is currently using an investigational device) within the 30 days before baseline, or at least 5 times the respective elimination half-life time (whichever is longer).
- Active TB or a history of incompletely treated TB, Quantiferon positive patients, Clinically significant abnormality consistent with prior/active TB infection based upon chest radiograph with at least posterior-anterior view, Suspected extrapulmonary TB infection, or patients at high risk of contracting TB.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
31 sites in 7 countries.
31 sites in 7 countries
United States9 sites
Orion Clinical Research Site Number : 8400003
Austin, Texas, 78759
Asthma and Allergy Associates, PC Site Number : 8400008
Colorado Springs, Colorado, 80907
E.P.I.M.R.D dba Western Sky Research, Inc. Site Number : 8400009
El Paso, Texas, 79903
Skin Sciences, PLLC Site Number : 8400005
Louisville, Kentucky, 40217
DS Research of Kentucky, LLC Site Number : 8400004
Louisville, Kentucky, 40241
Florida International Research Center Site Number : 8400002
Miami, Florida, 33173
National Allergy and Asthma Research, LLC. Site Number : 8400007
North Charleston, South Carolina, 29420
Antelope Valley Clinical Trials Site Number : 8400001
Northridge, California, 91325
Integrative Skin Care of MS/SKYCRNG Site Number : 8400011
Ridgeland, Mississippi, 39157
Canada7 sites
Investigational Site Number : 1240013
Greater Sudbury, Ontario, P3E 5M4
Investigational Site Number : 1240001
London, Ontario, N6A2C2
Investigational Site Number : 1240002
Markham, Ontario, L3P 1X3
Investigational Site Number : 1240004
Québec, G1V 4T3
Investigational Site Number : 1240008
Red Deer, Alberta, T4P 1K4
Investigational Site Number : 1240011
Toronto, Ontario, M2N 3A6
Investigational Site Number : 1240007
Toronto, Ontario, M3H 5Y8
Poland5 sites
Investigational Site Number : 6160008
Chojnice, 89600
Investigational Site Number : 6160005
Gdansk, Pomeranian Voivodeship, 80-546
Investigational Site Number : 6160001
Lodz, Lódzkie, 90-436
Investigational Site Number : 6160002
Lodz, 93-530
Investigational Site Number : 6160004
Warsaw, 00-215
Czechia4 sites
Investigational Site Number : 2030004
Olomouc, 779 00
Investigational Site Number : 2030003
Pardubice, 53002
Investigational Site Number : 2030002
Pilsen, 30599
Investigational Site Number : 2030001
Prague, 160 00
Chile3 sites
Investigational Site Number : 1520004
Santiago, Reg Metropolitana de Santiago, 7580206
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, 7640881
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, 8420383
Germany2 sites
Investigational Site Number : 2760001
Bad Bentheim, 48455
Investigational Site Number : 2760002
Friedrichshafen, 88045
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Proof-of-concept Study Evaluating Efficacy and Safety of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis Who Are Inadequate Responders or Intolerant to Topical Corticosteroids
This was a parallel treatment, Phase 2, double-blind, 2-arm, placebo-controlled study with 2 staggered cohorts (2 arms in each cohort) to evaluate the efficacy and safety of rilzabrutinib in adult participants (aged at least 18 years) with moderate-to-severe AD and intolerance or inadequate response to topical corticosteroids (TCS).
The total study duration per participant was expected to be approximately 21 weeks, including up to 4 weeks of screening, 16 weeks of on-treatment double-blind period, 1 week of post-treatment follow-up.
- Conditions
- Atopic Dermatitis
- Being tested
- Placebo, Rilzabrutinib
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Pharmaceutical form: Tablet Route of administration: Oral
RilzabrutinibDrug
Also called PRN1008/SAR444671
Pharmaceutical form: Tablet Route of administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| BID cohort: Placebo | Placebo comparator | Participants received placebo matched to rilzabrutinib orally BID from Day 1 up to Week 16. Consecutive doses were ideally administered 12 hours apart (and not less than 8 hours apart). Receives: Drug: Placebo |
| BID cohort: Rilzabrutinib | Experimental | Participants received rilzabrutinib 400 milligrams (mg) orally BID from Day 1 up to Week 16. Consecutive doses were ideally administered 12 hours apart (and not less than 8 hours apart). Receives: Drug: Rilzabrutinib |
| TID cohort: Placebo | Placebo comparator | Participants received placebo matched to rilzabrutinib orally TID from Day 1 up to Week 16. Consecutive doses were ideally administered at least 6 hours apart (and not less than 4 hours apart). Receives: Drug: Placebo |
| TID cohort: Rilzabrutinib | Experimental | Participants received rilzabrutinib 400 mg orally TID from Day 1 up to Week 16. Consecutive doses were ideally administered at least 6 hours apart (and not less than 4 hours apart). Receives: Drug: Rilzabrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score
The EASI index is a validated investigator-administered scoring system used to measure the severity of clinical signs in atopic dermatitis (AD). Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) were each assessed for severity by the investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement were assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. 0: 0% of body surface area (BSA) involvement with AD; 1: 1-9%; 2: 10-29%; 2: 30-49%; 4: 50-69%; 5: 70-89% and 6: 90-100% of BSA involvement with AD. Total score ranged from 0 (minimum) to 72 (maximum); higher scores indicated greater severity of AD. Baseline was defined as the Day 1 assessment value.
Measured: Baseline (Day 1) to Week 16
Secondary outcomes (11)
Percentage of Participants With Investigator's Global Assessment (IGA) of 0 or 1 At Week 16
IGA is a static 5-point measure of disease severity based on an overall assessment of the skin lesions on a 5-point scale (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). Higher score indicated higher severity.
Measured: Week 16
Percentage of Participants Achieving EASI-75 (Reduction of EASI Score By ≥75% From Baseline) At Week 16
The EASI index is a validated investigator-administered scoring system used to measure the severity of clinical signs in AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) were each assessed for severity by the investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement were assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. 0: 0% of BSA involvement with AD; 1: 1-9%; 2: 10-29%; 2: 30-49%; 4: 50-69%; 5: 70-89% and 6: 90-100% of BSA involvement with AD. Total score ranged from 0 (minimum) to 72 (maximum); higher scores indicated greater severity of AD. Participants who achieved EASI-75 were defined as participants with reduction of EASI score by ≥75% from baseline.
Measured: Baseline (Day 1) and at Week 16
Percentage Of Participants With Reduction of Weekly Average of Daily Peak Pruritus Numerical Rating Scale (PP-NRS) of ≥4 Points From Baseline at Week 16
The PP-NRS is a simple assessment tool that participants used to report the intensity of their pruritus (itch) during a daily recall period. Participants were asked to rate their worst itch on a 0 (no itch) to 10 (worst itch imaginable) NRS by answering the following question: For itch intensity, "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". The total score on the scale ranged from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicated worse symptoms. A minimum of 4 daily scores out of the 7 days is required to calculate the baseline average score.
Measured: Baseline (Day 1) and at Week 16
Number of Participants With Weekly Average of Daily PP-NRS Reduction ≥4 From Baseline During The 16-Week Treatment Period
The PP-NRS is a simple assessment tool that participants used to report the intensity of their pruritus (itch) during a daily recall period. Participants were asked to rate their worst itch on a 0 (no itch) to 10 (worst itch imaginable) NRS by answering the following question: For itch intensity, "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". The total score on the scale ranged from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicated worse symptoms. A minimum of 4 daily scores out of the 7 days is required to calculate the baseline average score.
Measured: Baseline (Day 1) and Week 16
Absolute Change From Baseline to Week 16 In EASI Score
The EASI index is a validated investigator-administered scoring system used to measure the severity of clinical signs in AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) were each assessed for severity by the investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement were assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. 0: 0% of BSA involvement with AD; 1: 1-9%; 2: 10-29%; 2: 30-49%; 4: 50-69%; 5: 70-89% and 6: 90-100% of BSA involvement with AD. Total score ranged from 0 (minimum) to 72 (maximum); higher scores indicated greater severity of AD. Baseline was defined as the Day 1 assessment value.
Measured: Baseline (Day 1) to Week 16
Percentage of Participants Achieving EASI-50/90 (Reduction of EASI Score by ≥50% or ≥90% From Baseline) at Week 16
The EASI index is a validated investigator-administered scoring system used to measure the severity of clinical signs in AD. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) were each assessed for severity by the investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement were assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. 0: 0% of BSA involvement with AD; 1: 1-9%; 2: 10-29%; 2: 30-49%; 4: 50-69%; 5: 70-89% and 6: 90-100% of BSA involvement with AD. Total score ranged from 0 (minimum) to 72 (maximum); higher scores indicated greater severity of AD. Participants who achieved EASI-50/90 were defined as participants with reduction of EASI score by ≥50% or ≥90% from baseline respectively.
Measured: Baseline (Day 1) and at Week 16
Change From Baseline to Week 16 in Percent BSA of AD
BSA affected by AD were assessed for each section of the body (the possible highest score for each region was: head and neck [10%], trunk including genitalia [30%], upper limbs [20%], lower limbs [40%]) and were reported as a percentage of all major body sections combined. Total score ranges from 0% to 100%. The higher score indicates a worse value and a lower score indicates a better value. Baseline was defined as the Day 1 assessment value.
Measured: Baseline (Day 1) to Week 16
Absolute Change From Baseline to Week 16 in Weekly Average of Daily PP-NRS
The PP-NRS is a simple assessment tool that participants used to report the intensity of their pruritus (itch) during a daily recall period. Participants were asked to rate their worst itch on a 0 (no itch) to 10 (worst itch imaginable) NRS by answering the following question: For itch intensity, "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". The total score on the scale ranged from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicated worse symptoms. A minimum of 4 daily scores out of the 7 days is required to calculate the baseline average score. Baseline was defined as the Day 1 assessment value.
Measured: Baseline (Day 1) to Week 16
Percent Change From Baseline to Week 16 in Weekly Average of Daily PP-NRS
The PP-NRS is a simple assessment tool that participants used to report the intensity of their pruritus (itch) during a daily recall period. Participants were asked to rate their worst itch on a 0 (no itch) to 10 (worst itch imaginable) NRS by answering the following question: For itch intensity, "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". The total score on the scale ranged from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicated worse symptoms. A minimum of 4 daily scores out of the 7 days is required to calculate the baseline average score. Baseline was defined as the Day 1 assessment value.
Measured: Baseline (Day 1) to Week 16
Percentage of Participants Achieving IGA*BSA-50/75/90 (Reduction of IGA*BSA by ≥50% or 75% or 90% From Baseline) At Week 16
IGA is a static 5-point measure of disease severity based on an overall assessment of the skin lesions on a 5-point scale (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). Higher score indicated higher severity. Participants who achieved IGA*BSA-50-75-90 were defined as participants with reduction of IGA*BSA by ≥50% or 75% or 90% from baseline.
Measured: Baseline (Day 1) and at Week 16
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Adverse Events of Special Interest (AESIs) and Study Intervention Discontinuation
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were defined as AEs that developed, worsened or became serious during the treatment-emergent period. SAE was any AE that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the investigator to the Sponsor was required.
Measured: Baseline (Day 1) to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start9 Sep 2021
- Primary completion23 Jun 2023
- Study completion23 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018806
- Sponsor's protocol ID
- ACT17207
- Other IDs
- U1111-1261-7565, ACT17207, 2021-001704-15
- Status last verified
- Jun 2026
- First submitted
- 19 Aug 2021
- Last updated
- 13 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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