Graves' DiseasePhase 2NCT07018323
A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease
A Phase 2 study testing IMVT-1402 in people with Graves' Disease, run by Immunovant Sciences GmbH at 163 sites in 18 countries.
Trial summary
This is a multi-center, global, randomized, double-blind, placebo-controlled Phase 2b study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment. 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?
- IMVT-1402
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 163 sitesin 18 countries
- Study dates
- 19 Jun 2025to May 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 with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.
- Male or female participants aged ≥ 18 years.
- Participants with diagnosis of GD who are hyperthyroid despite ATD treatment.
- Other, more specific inclusion criteria are defined in the protocol.
Who cannot join
- Have previously been successfully treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy.
- Have an autoimmune disease other than GD requiring treatment that, in the Investigator's judgment, puts the participant at undue risk.
- Have moderate-to-severe active thyroid eye disease (TED) and are expected to require immediate surgical intervention and/or are planning corrective surgery/irradiation or medical therapy for TED during study participation.
- Additional exclusion criteria are defined in the protocol.
Trial locations and contacts
163 sites in 18 countries. Contact the study team or a site near you to ask about taking part.
163 sites in 18 countries
United States33 sites, 31 recruiting
- Recruiting
Site Number - 1013
Aurora, Colorado, 80045
- Recruiting
Site Number - 1010
Chapel Hill, North Carolina, 27514
- Recruiting
Site Number - 1020
Columbus, Georgia, 31904
- Recruiting
Site Number -1014
Concord, California, 94520
- Recruiting
Site Number - 1029
Dallas, Texas, 75224
- Recruiting
Site Number - 1024
Doral, Florida, 33166
- Recruiting
Site Number - 1002
El Paso, Texas, 79935
- Recruiting
Site Number - 1003
Fort Worth, Texas, 76132
- Recruiting
Site Number - 1008
Hialeah, Florida, 33016
- Recruiting
Site Number - 1026
Hickory, North Carolina, 28601
- Recruiting
Site Number - 1031
Houston, Texas, 77030
- Recruiting
Site Number - 1028
Houston, Texas, 77054
- Completed
Site Number -1023
Irving, Texas, 75031
- Recruiting
Site Number - 1021
Irving, Texas, 75039
- Recruiting
Site Number - 1033
Jefferson City, Missouri, 65109
- Recruiting
Site Number - 1004
Kansas City, Missouri, 64110
- Recruiting
Site Number - 1032
Long Island City, New York, 11106
- Recruiting
Site Number - 1030
Louisville, Kentucky, 40202
- Recruiting
Site Number - 1025
McKinney, Texas, 75069
- Recruiting
Site Number - 1017
Memphis, Tennessee, 38119
- Recruiting
Site Number - 1000
Miami, Florida, 33143
- Recruiting
Site Number - 1001
Morehead City, North Carolina, 27577
- Recruiting
Site Number - 1027
New Hyde Park, New York, 11434
- Withdrawn
Site Number - 1009
New York, New York, 10022
- Recruiting
Site Number - 1016
Norfolk, Virginia, 23510
- Recruiting
Site Number - 1007
Oklahoma City, Oklahoma, 73134
- Recruiting
Site Number - 1034
Raleigh, North Carolina, 27612
- Recruiting
Site Number - 1012
Reno, Nevada, 89511
- Recruiting
Site Number - 1011
San Antonio, Texas, 78231
- Recruiting
Site Number - 1019
St Louis, Missouri, 63110
- Recruiting
Site Number - 1022
Topeka, Kansas, 66606
- Recruiting
Site Number - 1015
Tucson, Arizona, 85710
- Recruiting
Site Number - 1018
Williamsville, New York, 14221
Brazil14 sites, 14 recruiting
- Recruiting
Site Number - 5513
Belo Horizonte, Minas Gerais, 30150-320
- Recruiting
Site Number - 5502
Brasília, 70200-730
- Recruiting
Site Number - 5500
Campinas, São Paulo, 09060-870
- Recruiting
Site Number - 5503
Curitiba, 80060-240
- Recruiting
Site Number - 5504
Curitiba, 80810040
- Recruiting
Site Number - 5511
Fortaleza, Ceará, 21941-913
- Recruiting
Site Number - 5501
Porto Alegre, 90035903
- Recruiting
Site Number - 5512
Rio de Janeiro, 21941-913
- Recruiting
Site Number - 5505
Santo André, São Paulo, 09060-870
- Recruiting
Site Number - 5506
São Paulo, 01221-020
- Recruiting
Site Number - 5508
São Paulo, 01228-000
- Recruiting
Site Number - 5510
São Paulo, 05403-000
- Recruiting
Site Number - 5507
São Paulo, 15500-003
- Recruiting
Site Number - 5509
São Paulo, 17504-072
Bulgaria14 sites, 14 recruiting
- Recruiting
Site Number - 5613
Dobrich, 7002
- Recruiting
Site Number - 5606
Plovdiv, 4001
- Recruiting
Site Number - 5607
Plovdiv, 4002
- Recruiting
Site Number - 5601
Sliven, 8800
- Recruiting
Site Number - 5612
Smolyan, 4700
- Recruiting
Site Number - 5610
Sofia, Sofia-Grad, 1431
- Recruiting
Site Number - 5604
Sofia, 1233
- Recruiting
Site Number - 5609
Sofia, 1431
- Recruiting
Site Number - 5608
Sofia, 1680
- Recruiting
Site Number- 5605
Sofia, 1750
- Recruiting
Site Number - 5602
Varna, 9002
- Recruiting
Site Number - 5603
Varna, 9020
- Recruiting
Site Number - 5611
Varna, 9020
- Recruiting
Site Number - 5600
Yambol, 8600
Italy13 sites, 13 recruiting
- Recruiting
Site Number - 6013
Acquaviva delle Fonti, 70021
- Recruiting
Site Number - 6007
Bergamo, 168
- Recruiting
Site Number - 6004
Bergamo, 24127
- Recruiting
Site Number - 6015
Cuneo, 12100
- Recruiting
Site Number - 6011
Livorno, 57124
- Recruiting
Site Number - 6003
Milan, 20132
- Recruiting
Site Number - 6014
Naples, 80131
- Recruiting
Site Number - 6006
Pavia, 27100
- Recruiting
Site Number - 6010
Rome, 128
- Recruiting
Site Number - 6001
Rome, 135
- Recruiting
Site Number - 6005
Rozzano, Milan, 20089
- Recruiting
Site Number - 6012
Torino, 10128
- Recruiting
Site Number - 6002
Udine, 33100
Israel12 sites, 12 recruiting
- Recruiting
Site Number - 4211
Beersheba, Southern District, 8410101
- Recruiting
Site Number - 4205
Haifa, Haifa District, 3104802
- Recruiting
Site Number - 4203
Haifa, Haifa District, 3109601
- Recruiting
Site Number - 4201
Jerusalem, 9103102
- Recruiting
Site Number - 4204
Jerusalem, 9112001
- Recruiting
Site Number - 4210
Kfar Saba, 4428164
- Recruiting
Site Number - 4209
Nahariya, Northern District, 2210001
- Recruiting
Site Number - 4200
Petah Tikva, 4941492
- Recruiting
Site Number - 4202
Ramat Gan, Central District, 5265601
- Recruiting
Site Number - 4208
Rehovot, 7661041
- Recruiting
Site Number - 4207
Tel Aviv, 6423906
- Recruiting
Site Number - 4206
Tzfat, Northern District, 1311001
Japan12 sites, 12 recruiting
- Recruiting
Site Number - 4001
Kamogawa, Chiba, 296-0041
- Recruiting
Site Number - 4011
Kitakyushu, Fukuoka, 807-8555
- Recruiting
Site Number - 4007
Kumamoto, 860-8556
- Recruiting
Site Number - 4004
Kurume, Fukuoka, 830-0011
- Recruiting
Site Number - 4006
Kyoto, 612-8555
- Recruiting
Site Number - 4008
Maebashi, Gunma, 371-8512
- Recruiting
Site Number - 4005
Minokamo, Gifu, 505-8510
- Recruiting
Site Number - 4002
Nagasaki, 852-8501
- Recruiting
Site Number - 4010
Nagoya, Aichi-ken, 467-8602
- Recruiting
Site Number - 4003
Nankoku, Kochi, 791-0295
- Recruiting
Site Number - 4012
Shibuya City, Tokyo, 150-8308
- Recruiting
Site Number - 4009
Yokohama, Kanagawa, 230-8765
Poland12 sites, 12 recruiting
- Recruiting
Site Number - 3004
Bialystok, Podlaskie Voivodeship, 15-276
- Recruiting
Site Number - 3002
Bydgoszcz, 85-605
- Recruiting
Site Number - 3010
Chorzów, 41-516
- Recruiting
Site Number - 3007
Kielce, 25-734
- Recruiting
Site Number - 3000
Lublin, 20-607
- Recruiting
Site Number - 3005
Olsztyn, 10-117
- Recruiting
Site Number - 3009
Opole, 45-301
- Recruiting
Site Number - 3006
Poznan, 60-693
- Recruiting
Site Number - 3001
Szczecin, West Pomeranian Voivodeship, 71-252
- Recruiting
Site Number - 3008
Warsaw, 02-482
- Recruiting
Site Number - 3011
Warsaw, 02-507
- Recruiting
Site Nnumber - 3003
Wroclaw, 50-367
Australia10 sites, 10 recruiting
- Recruiting
Site Number - 5102
Box Hill, Victoria, 3128
- Recruiting
Site Number - 5101
Brisbane, Queensland, 4101
- Recruiting
Site Number - 5107
Douglas, Queensland, 4814
- Recruiting
Site Number - 5104
Geelong, Victoria, 3220
- Recruiting
Site Number - 5110
Parkville, Victoria, 3050
- Recruiting
Site Number - 5108
Perth, 6009
- Recruiting
Site Number - 5109
Saint Leonards, 2065
- Recruiting
Site Number - 5100
Southport, Queensland, 4222
- Recruiting
Site Number - 5105
Sydney, New South Wales, 2050
- Recruiting
Site Number - 5103
Warrawong, New South Wales, 2502
South Korea8 sites, 8 recruiting
- Recruiting
Site Number - 4500
Daegu, 42415
- Recruiting
Site Number - 4503
Goyang, 410-77
- Recruiting
Site Number - 4504
Guri-si, 11923
- Recruiting
Site Number - 4501
Seoul, 02841
- Recruiting
Site Number - 4508
Seoul, 03080
- Recruiting
Site Number - 4506
Seoul, 03181
- Recruiting
Site Number - 4505
Seoul, 05278
- Recruiting
Site Number - 4507
Seoul, 6591
Georgia6 sites, 5 recruiting
- Withdrawn
Site Number - 8004
Imereti, 4600
- Recruiting
Site Number - 8003
Tbilisi, 0114
- Recruiting
Site Number - 8000
Tbilisi, 0145
- Recruiting
Site Number - 8002
Tbilisi, 0159
- Recruiting
Site Number - 8001
Tbilisi, 0160
- Recruiting
Site Number - 8005
Tbilisi, 0186
Latvia6 sites, 5 recruiting
- Recruiting
Site Number - 4600
Ogre, LV-5001
- Recruiting
Site Number - 4605
Riga, LV-1002
- Recruiting
Site Number - 4602
Riga, LV-1006
- Recruiting
Site Number - 4603
Riga, LV-1050
- Recruiting
Site Number - 4604
Sigulda, LV-2150
- Withdrawn
Site Number - 4601
Ventspils, LV-3601
United Kingdom6 sites, 6 recruiting
- Recruiting
Site Number - 7009
Cornwell, TR1 3LJ
- Recruiting
Site Number - 7006
London, SE1 9RT
- Recruiting
Site Number - 7001
London, W2 1NY
- Recruiting
Site Number - 7003
Merthyr Tydfil, CF72 8XR
- Recruiting
Site Number - 7010
Salford, M6 8HD
- Recruiting
Site Number - 7008
Surrey, GU2 7XX
Czechia4 sites, 4 recruiting
- Recruiting
Site Number - 3203
Náchod, 547 01
- Recruiting
Site Number - 3201
Prague, 149 00
- Recruiting
Site Number - 3200
Prague, 181 00
- Recruiting
Site Number - 3202
Prague, 190 14
Greece4 sites, 4 recruiting
- Recruiting
Site Number - 3902
Athens, 106 76
- Recruiting
Site Number - 3900
Athens, 115 27
- Recruiting
Site Number - 3901
Athens, 115 28
- Recruiting
Site Number - 3903
Thessaloniki, 546 42
Netherlands4 sites, 3 recruiting
- Withdrawn
Site Number - 2203
Rotterdam, South Holland, 3045 PM
- Recruiting
Site Number - 2200
Rotterdam, South Holland, 3079 DZ
- Recruiting
Site Number - 2201
Rotterdam, South Holland, 3083 AN
- Recruiting
Site Number - 2202
Zwijndrecht, South Holland, 3318 AT
Chile2 sites, 2 recruiting
- Recruiting
Site Number - 5700
Santiago, 7690000
- Recruiting
Site Number - 5701
Santiago, 8380456
New Zealand2 sites, 1 recruiting
- Withdrawn
Site Number - 3301
Auckland, 2025
- Recruiting
Site Number - 3300
Wellington, 6242
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves' Disease
This is a multi-center, global, randomized, double-blind, placebo-controlled Phase 2b study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment.
- Conditions
- Graves' Disease
- Being tested
- IMVT-1402, Placebo
- Keywords
- IMVT-1402, Graves' disease, Thyroid-Stimulating Hormone Receptor, Immunoglobulin G, Antithyroid drug, Imeroprubart
- Medical subject headings
- Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMVT-1402Drug
Dose 1 for 26 weeks
IMVT-1402Drug
Dose 2 for 26 weeks
PlaceboDrug
For 26 weeks
| Study group | Role | What they receive |
|---|---|---|
| IMVT-1402 Dose 1 | Experimental | Not described Receives: Drug: IMVT-1402 |
| IMVT-1402 Dose 2 | Experimental | Not described Receives: Drug: IMVT-1402 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 1)
Measured: Week 26
Secondary outcomes (9)
Percentage of participants who have triiodothyronine (T3) (Total of T3 or free triiodothyronine [FT3]) and free thyroxine (FT4) ≤ upper limit of normal (ULN) and are off ATD at Week 26 (Dose 1)
Measured: Week 26
Percentage of participants who are euthyroid, off ATD, and seronegative at Week 26 (Dose 1)
Measured: Week 26
Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 2)
Measured: Week 26
Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN and are off ATD at Week 26 (Dose 2)
Measured: Week 26
Percentage of participants who are euthyroid, off ATD, and seronegative (Dose 2)
Measured: Week 26
Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 4 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline (Dose 1)
Measured: Baseline, Week 4
Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 2 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline (Dose 1)
Measured: Baseline, Week 2
Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 4 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline (Dose 2)
Measured: Baseline, Week 4
Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 2 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline (Dose 2)
Measured: Baseline, Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start19 Jun 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 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.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immunovant Sciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018323
- Sponsor's protocol ID
- IMVT-1402-2503
- Other IDs
- 2025-521920-31-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 14 May 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves' Disease
- ClinicalTrials.gov ID
- NCT07018323
- Acronym / sponsor ID
- IMVT-1402-2503
- Conditions
- Graves' Disease
- Keywords
- IMVT-1402, Graves' disease, Thyroid-Stimulating Hormone Receptor, Immunoglobulin G, Antithyroid drug, Imeroprubart
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Immunovant Sciences GmbHIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 12 Jun 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 multi-center, global, randomized, double-blind, placebo-controlled Phase 2b study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IMVT-1402 Dose 1 | Experimental | Drug: IMVT-1402 |
| IMVT-1402 Dose 2 | Experimental | Drug: IMVT-1402 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.
- Male or female participants aged ≥ 18 years.
- Participants with diagnosis of GD who are hyperthyroid despite ATD treatment.
- Other, more specific inclusion criteria are defined in the protocol.
Key exclusion criteria (4 listed)
- Have previously been successfully treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy.
- Have an autoimmune disease other than GD requiring treatment that, in the Investigator's judgment, puts the participant at undue risk.
- Have moderate-to-severe active thyroid eye disease (TED) and are expected to require immediate surgical intervention and/or are planning corrective surgery/irradiation or medical therapy for TED during study participation.
- Additional exclusion criteria are defined in the protocol.
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 |
|---|---|---|
| IMVT-1402Dose 1 for 26 weeks | Drug | IMVT-1402 Dose 1 |
| IMVT-1402Dose 2 for 26 weeks | Drug | IMVT-1402 Dose 2 |
| PlaceboFor 26 weeks | Drug | Placebo |
Primary outcome
Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 1)
Time frame: Week 26
9 secondary outcomes
Percentage of participants who have triiodothyronine (T3) (Total of T3 or free triiodothyronine [FT3]) and free thyroxine (FT4) ≤ upper limit of normal (ULN) and are off ATD at Week 26 (Dose 1)
Time frame: Week 26
Percentage of participants who are euthyroid, off ATD, and seronegative at Week 26 (Dose 1)
Time frame: Week 26
Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 2)
Time frame: Week 26
Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN and are off ATD at Week 26 (Dose 2)
Time frame: Week 26
Percentage of participants who are euthyroid, off ATD, and seronegative (Dose 2)
Time frame: Week 26
Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 4 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline (Dose 1)
Time frame: Baseline, Week 4
Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 2 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline (Dose 1)
Time frame: Baseline, Week 2
Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 4 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline (Dose 2)
Time frame: Baseline, Week 4
Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 2 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline (Dose 2)
Time frame: Baseline, Week 2
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 30 Oct 2026.
- Individual participant dataSharing planned: No
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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.
163 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMVT-1402 in people with Graves' Disease, run by Immunovant Sciences GmbH at 163 sites in 18 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 4 inclusion and 4 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 30 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 163 sites in United States, Brazil, Bulgaria, Italy, Israel and 13 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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 Central Study Contact (18007970414, clinicaltrials@immunovant.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 1) (time frame: Week 26). 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 30 Oct 2026.