Graves' DiseasePhase 2NCT06984627
A Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease
A Phase 2 study testing Rilzabrutinib dose 1 and Rilzabrutinib dose 2 in people with Graves' Disease, run by Sanofi at 24 sites in 9 countries.
Trial summary
This is a parallel group, Phase 2, 2-arm study to measure the treatment effect and safety of rilzabrutinib dose 1 or rilzabrutinib dose 2 in participants with Graves' disease, with and without Graves' orbitopathy, aged 18 years or older. Study details include: Screening period (up to 4 weeks). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Graves' Disease
- What is being tested?
- Rilzabrutinib dose 1 and Rilzabrutinib dose 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 24 sitesin 9 countries
- Study dates
- 2 Sep 2025to 11 Mar 2027
- Phase
- Phase 2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who have a confirmed diagnosis of Graves' disease with active hyperthyroidism, with or without active Graves' orbitopathy at the time of screening.
- A subset of participants will have a diagnosis of active Graves' orbitopathy, as confirmed by ophthalmic exam at screening and a clinical activity score (CAS) ≥3 for the most severely affected eye, and associated with one or more of the following: lid retraction ≥2 mm, moderate or severe soft tissue involvement, proptosis ≥2 mm, and/or intermittent or constant diplopia.
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Who cannot join
- History of hyperthyroidism not caused by Graves' disease (eg, hyperthyroidism due to toxic multinodular goiter, autonomous thyroid nodule, acute inflammatory thyroiditis).
- History of thyroid storm or at high risk of developing thyroid storm as determined by evaluating clinician.
- Enlarged thyroid goiter causing upper airway obstruction and/or requiring surgical intervention during the study period.
- For participant with Graves' orbitopathy, requires immediate surgical ophthalmological intervention or is planning corrective surgery/irradiation during the course of the study.
- Sight threatening Graves' orbitopathy or decreased visual acuity due to optic neuropathy within the last 6 months.
- Corneal decompensation unresponsive to medical management.
- Onset of Graves' orbitopathy symptoms >9 months prior to baseline.
- 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
24 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
24 sites in 9 countries
Italy5 sites, 5 recruiting
- Recruiting
Investigational Site Number : 3800005
Merano, 39012
- Recruiting
Investigational Site Number : 3800001
Milan, Milano, 20122
- Recruiting
Investigational Site Number : 3800004
Milan, Milano, 20132
- Recruiting
Investigational Site Number : 3800003
Palermo, 90127
- Recruiting
Investigational Site Number : 3800002
Pisa, 56126
Argentina3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 0320002
Buenos Aires, 1061
- Recruiting
Investigational Site Number : 0320001
Buenos Aires, 1119
- Recruiting
Investigational Site Number : 0320003
Córdoba, 5000
Canada3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 1240003
Calgary, Alberta, T2N 4L7
- Recruiting
Investigational Site Number : 1240001
Sherbrooke, Quebec, J1H 5N4
- Recruiting
Investigational Site Number : 1240002
Surrey, British Columbia, V3T 4G8
Greece3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 3000002
Athens, 115 27
- Recruiting
Investigational Site Number : 3000001
Athens, 124 62
- Recruiting
Investigational Site Number : 3000003
Larissa, 411 10
Spain3 sites, 1 recruiting
- Completed
Investigational Site Number : 7240002
Barcelona, Catalunya [Cataluña], 08036
- Completed
Investigational Site Number : 7240001
Pamplona, Navarre, 31008
- Recruiting
Investigational Site Number : 7240004
Seville, Sevilla, 41009
Chile2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 1520001
Concepción, Biobio, 4070566
- Recruiting
Investigational Site Number : 1520002
Iquique, Tarapacá, \t765000
Germany2 sites
- Completed
Investigational Site Number : 2760002
Essen, 45147
- Completed
Investigational Site Number : 2760001
Frankfurt, 60590
United Kingdom2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 8260003
Milton Keynes, Buckinghamshire, MK6 5LD
- Recruiting
Investigational Site Number : 8260001
Newcastle upon Tyne, England, NE2 4HH
Hungary1 site
- Active, not recruiting
Investigational Site Number : 3480001
Pécs, 7624
About this study
Official title: An Open-label Phase 2 Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease
This is a parallel group, Phase 2, 2-arm study to measure the treatment effect and safety of rilzabrutinib dose 1 or rilzabrutinib dose 2 in participants with Graves' disease, with and without Graves' orbitopathy, aged 18 years or older.
Study details include:
- Screening period (up to 4 weeks).
- Treatment period (up to 16 weeks).
- Follow-up period (4 weeks). The number of visits will be up to 13.
- Conditions
- Graves' Disease
- Being tested
- Rilzabrutinib dose 1, Rilzabrutinib dose 2
- Medical subject headings
- Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rilzabrutinib dose 1Drug
Also called SAR444671
Pharmaceutical form:Tablet-Route of administration:Oral
Rilzabrutinib dose 2Drug
Also called SAR444671
Pharmaceutical form:Tablet-Route of administration:Oral
| Study group | Role | What they receive |
|---|---|---|
| Rilzabrutinib dose 1 | Experimental | Rilzabrutinib Receives: Drug: Rilzabrutinib dose 1 |
| Rilzabrutinib dose 2 | Experimental | Rilzabrutinib Receives: Drug: Rilzabrutinib dose 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in FT4 levels
Free thyroxine
Measured: At Week16
Secondary outcomes (4)
Percent change from baseline in FT3 levels
Free triiodothyronine
Measured: At Week16
Proportion of participants with FT4 levels within normal limits
Measured: At Week16
Proportion of participants with FT3 levels within normal limits
Measured: At Week16
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs) and withdrawals due to TEAEs during the study period
Measured: Up to week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start2 Sep 2025
- Primary completion11 Feb 2027 (estimated)
- Study completion11 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves' DiseaseStudies 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984627
- Sponsor's protocol ID
- PDY18663
- Other IDs
- 2025-521023-75, U1111-1316-0208, 2025
- Status last verified
- Oct 2026
- First submitted
- 14 May 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase 2 Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease
- ClinicalTrials.gov ID
- NCT06984627
- Acronym / sponsor ID
- PDY18663
- Conditions
- Graves' Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 11 Feb 2027 (estimated)
- Study completion
- 11 Mar 2027 (estimated)
- First posted
- 22 May 2025 (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 parallel group, Phase 2, 2-arm study to measure the treatment effect and safety of rilzabrutinib dose 1 or rilzabrutinib dose 2 in participants with Graves' disease, with and without Graves' orbitopathy, aged 18 years or older.
Study details include:
- Screening period (up to 4 weeks).
- Treatment period (up to 16 weeks).
- Follow-up period (4 weeks). The number of visits will be up to 13.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rilzabrutinib dose 1 | Experimental | Drug: Rilzabrutinib dose 1Rilzabrutinib |
| Rilzabrutinib dose 2 | Experimental | Drug: Rilzabrutinib dose 2Rilzabrutinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants who have a confirmed diagnosis of Graves' disease with active hyperthyroidism, with or without active Graves' orbitopathy at the time of screening.
- A subset of participants will have a diagnosis of active Graves' orbitopathy, as confirmed by ophthalmic exam at screening and a clinical activity score (CAS) ≥3 for the most severely affected eye, and associated with one or more of the following: lid retraction ≥2 mm, moderate or severe soft tissue involvement, proptosis ≥2 mm, and/or intermittent or constant diplopia.
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Key exclusion criteria (8 listed)
- History of hyperthyroidism not caused by Graves' disease (eg, hyperthyroidism due to toxic multinodular goiter, autonomous thyroid nodule, acute inflammatory thyroiditis).
- History of thyroid storm or at high risk of developing thyroid storm as determined by evaluating clinician.
- Enlarged thyroid goiter causing upper airway obstruction and/or requiring surgical intervention during the study period.
- For participant with Graves' orbitopathy, requires immediate surgical ophthalmological intervention or is planning corrective surgery/irradiation during the course of the study.
- Sight threatening Graves' orbitopathy or decreased visual acuity due to optic neuropathy within the last 6 months.
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 |
|---|---|---|
| Rilzabrutinib dose 1Also: SAR444671Pharmaceutical form:Tablet-Route of administration:Oral | Drug | Rilzabrutinib dose 1 |
| Rilzabrutinib dose 2Also: SAR444671Pharmaceutical form:Tablet-Route of administration:Oral | Drug | Rilzabrutinib dose 2 |
Primary outcome
Percent change from baseline in FT4 levels
Time frame: At Week16
Free thyroxine
4 secondary outcomes
Percent change from baseline in FT3 levels
Time frame: At Week16
Proportion of participants with FT4 levels within normal limits
Time frame: At Week16
Proportion of participants with FT3 levels within normal limits
Time frame: At Week16
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs) and withdrawals due to TEAEs during the study period
Time frame: Up to week 20
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 28 Oct 2026.
- PDY18663 Plain Language Results SummaryLink provided by the sponsor.
- For EU sites click here and navigate to 'Locations and contact points'Link provided by the sponsor.
- Individual participant dataSharing planned: 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
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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.
Trial Transparency email recommended (Toll free for US & Canada) contact
24 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rilzabrutinib dose 1 and Rilzabrutinib dose 2 in people with Graves' Disease, run by Sanofi at 24 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 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 28 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 24 sites in Italy, Argentina, Canada, Greece, Spain and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, Contact-US@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from baseline in FT4 levels (time frame: At Week16). 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 28 Oct 2026.