Primary Membranous NephropathyPhase 3MAJESTYNCT04629248
A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy
A Phase 3 study testing Obinutuzumab, Tacrolimus and Methylprednisolone in people with Primary Membranous Nephropathy, run by Hoffmann-La Roche at 50 sites in 11 countries.
Trial summary
This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics (PK) of obinutuzumab compared with tacrolimus in participants with primary membranous nephropathy (pMN). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Membranous Nephropathy
- What is being tested?
- Obinutuzumab, Tacrolimus and Methylprednisolone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 50 sitesin 11 countries
- Study dates
- 25 Jun 2021to 21 Dec 2027
- Phase
- Phase 3
- 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
- Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening
- Screening urinary protein-to-creatinine ratio (UPCR) >= 5 g/g from 24-hour urine collection after best supportive care for >= 3 months prior to screening or screening UPCR >= 4 g/g after best supportive care for >= 6 months prior to screening
- eGFR >= 40 mL/min/1.73m^2 or qualified endogenous creatinine clearance >= 40 mL/min/1.73m^2 based on 24-hour urine collection during screening
- Other inclusion criteria may apply
Who cannot join
- Participants with a secondary cause of MN
- Pregnancy or breastfeeding
- Evidence of >= 50% reduction in proteinuria during the previous 6 months prior to randomization
- Severe renal impairment, including the need for dialysis or renal replacement therapy
- Type 1 or 2 diabetes mellitus
- Receipt of an excluded therapy, including any anti-CD20 therapy less than 9 months prior to or during screening; or cyclophosphamide, tacrolimus, or cyclosporin less than 6 months prior to or during screening
Show all 12Show fewer
- Significant or uncontrolled medical disease which, in the investigator's opinion, would preclude participant participation
- Known active infection of any kind or recent major episode of infection
- Major surgery requiring hospitalization within the 4 weeks prior to screening
- Current active alcohol or drug abuse or history of alcohol or drug abuse within 12 months prior to screening
- Intolerance or contraindication to study therapies
- Other exclusion criteria may apply
Trial locations and contacts
50 sites in 11 countries.
50 sites in 11 countries
China10 sites
Peking University First Hospital
Beijing, 100034
Sichuan Provincial People's Hospital
Chengdu, 610072
The 1st Affiliated hospital of Fujian Medical University
Fuzhou, 350005
Nanfang Hospital, Southern Medical University
Guangzhou, 510515
Zhejiang Provincial People?s Hospital
Hangzhou, Zhejiang, 310014
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200025
Huashan Hospital, Fudan University
Shanghai, 200040
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430030
The First Affiliated Hospital of Xian Jiao Tong University
Xi'an, 710061
General Hospital of Ningxia Medical University
Yinchuan, 750004
United States8 sites
Accel Research Sites; Mid-Florida Kidney and Hypertension Care
Altamonte Springs, Florida, 32701
University of Colorado in Denver-Anschutz Medical Campus
Aurora, Colorado, 80045
Nephrotex Research Group
Dallas, Texas, 75231
Henry Ford Hospital
Detroit, Michigan, 48202
University of Iowa
Iowa City, Iowa, 52242
Columbia University Medical Center
New York, New York, 10032
Mayo Clinic
Rochester, Minnesota, 55902
Kaiser Permanente - San Francisco Medical Center
San Francisco, California, 94118
Italy5 sites
Policlinico di Bari
Bari, Apulia, 70124
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
Brescia, Lombardy, 25123
ASST Monza - Ospedale San Gerardo
Monza, Lombardy, 20900
A.O. U. Federico II
Naples, Campania, 80131
Ospedale San Giovanni Bosco
Turin, Piedmont, 10154
Poland5 sites
Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego
?ód?, 90-153
Uniwersytecki Szpital Kliniczny im WAM CSW
?ód?, 92-213
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bia?ystok, 15-276
Szpital Uniwersytecki im.dr.A.Jurasza w Bydgoszczy
Bydgoszcz, 85-094
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroc?aw, 50-556
Spain5 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Clinic i Provincial
Barcelona, 08036
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Virgen del Rocío
Seville, 41013
Brazil4 sites
Ser Servicos Especializados Em Reumatologia
Salvador, Estado de Bahia, 40150-150
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000
Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos
São Paulo, São Paulo, 04038-002
Hospital das Clinicas - FMUSP
São Paulo, São Paulo, 05403-000
Argentina3 sites
Organizacion Medica de Investigacion
Buenos Aires, C1015ABO
CINME
Buenos Aires, C1056ABI
Hospital Britanico Buenos Aires
Buenos Aires, C1280AEB
France3 sites
Hopital Henri Mondor
Créteil, 94010
Hopital Tenon
Paris, 75020
Hopital Rangueil
Toulouse, 31059
Russia3 sites
First Moscow State Medical University n.a. I.M. Sechenov
Moscow, Moscow Oblast, 119021
Rostov State Medical Uni
Rostov-on-Don, Rostov Oblast, 344022
German clinic
Saint Petersburg, Sankt-Peterburg, 196070
Turkey (Türkiye)3 sites
Hacettepe Uni School of Medicine
Ankara, 06100
Akdeniz University Medical Faculty
Antalya, 07059
Ege Uni School of Medicine
Izmir, 35100
About this study
Official title: A Phase III Randomized, Open-Label Active Comparator-Controlled Multicenter Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients With Primary Membranous Nephropathy
This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics (PK) of obinutuzumab compared with tacrolimus in participants with primary membranous nephropathy (pMN).
- Conditions
- Primary Membranous Nephropathy
- Being tested
- Obinutuzumab, Tacrolimus, Methylprednisolone, Acetaminophen, Diphenhydramine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObinutuzumabDrug
Also called Gazyva
Open Label: An intravenous (IV) infusion of 1000 milligram (mg) of obinutuzumab will be administered at Week 0, Week 2, Week 24, and Week 26. Participants who relapse during the open-label treatment period may be eligible for further treatment.
TacrolimusDrug
Open Label: Participants will receive tacrolimus at a starting oral dose (PO) of 0.05 mg/kilogram (kg) (participant dry weight) per day divided into two equal doses given at 12-hour intervals, titrated to serum trough level 5-7 Nanograms per millilitre (ng/mL). Optimized tacrolimus dose will be maintained for a maximum 52 weeks dependent on response and then tapered over 8 weeks. Participants who relapse during the open-label treatment period will have their dose of tacrolimus tapered over 8 weeks and may be eligible for further treatment.
Premedication: Methylprednisolone 80 mg IV will be administered between 30 and 60 minutes prior to the obinutuzumab infusion in all study periods.
AcetaminophenDrug
Premedication: Acetaminophen (650-1000 mg, or equivalent dose of a similar agent) PO or IV will be administered between 30 and 60 minutes prior to the obinutuzumab infusion in all study periods.
DiphenhydramineDrug
Premedication: Diphenhydramine (50 mg, or equivalent dose of a similar agent) PO or IV will be administered between 30 and 60 minutes prior to the obinutuzumab infusion in all study periods.
| Study group | Role | What they receive |
|---|---|---|
| Open Label Treatment: Obinutuzumab | Experimental | Participants will be randomized at a 1:1 ratio to receive open-label treatment with obinutuzumab according to region and anti-phospholipase A2 receptor (PLA2R) autoantibody titer (using Euroimmun ELISA). Receives: Drug: Obinutuzumab; Drug: Methylprednisolone; Drug: Acetaminophen; Drug: Diphenhydramine |
| Open Label Treatment: Tacrolimus | Active comparator | Participants will be randomized at a 1:1 ratio to receive open-label treatment with tacrolimus according to region and anti-PLA2R autoantibody titer (using Euroimmun ELISA). Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants who Achieve a Complete Remission (CR) at Week 104
Measured: Week 104
Secondary outcomes (14)
Percentage of Participants who Achieve an Overall Remission at Week 104
Measured: Week 104
Percentage of Participants who Achieve CR at Week 76
Measured: Week 76
Time to Treatment Failure, Meeting Escape Criteria, or Relapse after Complete or Partial Remission
Measured: Up to 8 years
Time to a Sustained Reduction of Estimated Glomerular Filtration Rate (eGFR) >= 30% from Baseline
Measured: Up to 8 years
Mean Change in T-score from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale at Week 104
Self-reported changes in fatigue will be measured using the PROMIS Fatigue Scale.
Measured: Baseline to Week 104
Duration of CR
Measured: Up to 8 years
Change in anti-PLA2R Autoantibody Titer
Measured: Baseline to Week 52
Mean Change from Baseline in the PROMIS Global Assessment of Physical Health Scale at Week 104
Self-reported changes in physical health will be measured using the PROMIS Physical Health Scale
Measured: Baseline to Week 104
Percentage of Participants with Adverse Events (AEs)
Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Measured: Up to 8 years
Percentage of Participants with AEs of Special Interest (AESIs)
AESIs are required to be reported by the investigator to the Sponsor immediately
Measured: Up to 8 years
Peripheral B-cell Counts at Specified Timepoints
Measured: Weeks 0 (baseline), 2, 4, 12, 24, 26, 36, 52, 64, 76, 88, 104, 117, 130, 156, 182, 208 and every 26 weeks thereafter
Serum Concentrations of Obinutuzumab at Specified Timepoints
Measured: Weeks 0 (baseline), 2, 4, 12, 24, 26, 36, 52, 64, 76, 88, 104, 117, 130, 143, 156, 169, 182, 195, 208, every 26 weeks thereafter
Prevalence of Anti-drug Antibodies (ADAs) to Obinutuzumab at Baseline
Measured: Open Label: Baseline; Escape Treatment: Week 0
Incidence of ADAs during the study
Measured: Weeks 2, 4, 12, 24, 26, 36, 52, 64, 76, 88, 104, 130, 156, 182, 208 and every 26 weeks thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start25 Jun 2021
- Primary completion22 Dec 2025
- Study completion21 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary Membranous NephropathyStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629248
- Sponsor's protocol ID
- WA41937
- Other IDs
- 2020-003233-38, 2023-506525-11-00, 2023
- Acronym
- MAJESTY
- Status last verified
- Sep 2026
- First submitted
- 27 Oct 2020
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Publications
Fervenza FC, Hou FF, Hao CM, Kirsztajn GM, Gesualdo L, Hryszko T, Pisani A, Roccatello D, Bomback AS, Rae J, Barmaki F, Berisha E, Schindler T, Omachi TA, Garg JP, Malvar A; MAJESTY Trial Investigators. Obinutuzumab or Tacrolimus in Primary Membranous Nephropathy. N Engl J Med. 2026 Jun 5. doi: 10.1056/NEJMoa2602678. Online ahead of print.
PubMed 42246654Dossier C, Bonneric S, Baudouin V, Kwon T, Prim B, Cambier A, Couderc A, Moreau C, Deschenes G, Hogan J. Obinutuzumab in Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome in Children. Clin J Am Soc Nephrol. 2023 Dec 1;18(12):1555-1562. doi: 10.2215/CJN.0000000000000288. Epub 2023 Sep 6.
PubMed 37678236Dossier C, Hogan J. Response to Majeranowski. Pediatr Nephrol. 2021 Jun;36(6):1653. doi: 10.1007/s00467-021-04982-4. Epub 2021 Mar 10. No abstract available.
PubMed 33693991
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized, Open-Label Active Comparator-Controlled Multicenter Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients With Primary Membranous Nephropathy
- ClinicalTrials.gov ID
- NCT04629248
- Acronym / sponsor ID
- MAJESTY / WA41937
- Conditions
- Primary Membranous Nephropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 21 Dec 2027 (estimated)
- First posted
- 16 Nov 2020 (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 study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics (PK) of obinutuzumab compared with tacrolimus in participants with primary membranous nephropathy (pMN).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Label Treatment: Obinutuzumab | Experimental | Drug: Obinutuzumab, Drug: Methylprednisolone, Drug: Acetaminophen, Drug: DiphenhydramineParticipants will be randomized at a 1:1 ratio to receive open-label treatment with obinutuzumab according to region and anti-phospholipase A2 receptor (PLA2R) autoantibody titer (using Euroimmun ELISA). |
| Open Label Treatment: Tacrolimus | Active comparator | Drug: TacrolimusParticipants will be randomized at a 1:1 ratio to receive open-label treatment with tacrolimus according to region and anti-PLA2R autoantibody titer (using Euroimmun ELISA). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening
- Screening urinary protein-to-creatinine ratio (UPCR) >= 5 g/g from 24-hour urine collection after best supportive care for >= 3 months prior to screening or screening UPCR >= 4 g/g after best supportive care for >= 6 months prior to screening
- eGFR >= 40 mL/min/1.73m^2 or qualified endogenous creatinine clearance >= 40 mL/min/1.73m^2 based on 24-hour urine collection during screening
- Other inclusion criteria may apply
Key exclusion criteria (12 listed)
- Participants with a secondary cause of MN
- Pregnancy or breastfeeding
- Evidence of >= 50% reduction in proteinuria during the previous 6 months prior to randomization
- Severe renal impairment, including the need for dialysis or renal replacement therapy
- Type 1 or 2 diabetes mellitus
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 |
|---|---|---|
| ObinutuzumabAlso: GazyvaOpen Label: An intravenous (IV) infusion of 1000 milligram (mg) of obinutuzumab will be administered at Week 0, Week 2, Week 24, and Week 26. Participants who relapse during the open-label treatment period may be eligible for further treatment. | Drug | Open Label Treatment: Obinutuzumab |
| TacrolimusOpen Label: Participants will receive tacrolimus at a starting oral dose (PO) of 0.05 mg/kilogram (kg) (participant dry weight) per day divided into two equal doses given at 12-hour intervals, titrated to serum trough level 5-7 Nanograms per millilitre (ng/mL). Optimized tacrolimus dose will be maintained for a maximum 52 weeks dependent on response and then tapered over 8 weeks. Participants who relapse during the open-label treatment period will have their dose of tacrolimus tapered over 8 weeks and may be eligible for further treatment. | Drug | Open Label Treatment: Tacrolimus |
| MethylprednisolonePremedication: Methylprednisolone 80 mg IV will be administered between 30 and 60 minutes prior to the obinutuzumab infusion in all study periods. | Drug | Open Label Treatment: Obinutuzumab |
| AcetaminophenPremedication: Acetaminophen (650-1000 mg, or equivalent dose of a similar agent) PO or IV will be administered between 30 and 60 minutes prior to the obinutuzumab infusion in all study periods. | Drug | Open Label Treatment: Obinutuzumab |
| DiphenhydraminePremedication: Diphenhydramine (50 mg, or equivalent dose of a similar agent) PO or IV will be administered between 30 and 60 minutes prior to the obinutuzumab infusion in all study periods. | Drug | Open Label Treatment: Obinutuzumab |
Primary outcome
Percentage of Participants who Achieve a Complete Remission (CR) at Week 104
Time frame: Week 104
14 secondary outcomes
Percentage of Participants who Achieve an Overall Remission at Week 104
Time frame: Week 104
Percentage of Participants who Achieve CR at Week 76
Time frame: Week 76
Time to Treatment Failure, Meeting Escape Criteria, or Relapse after Complete or Partial Remission
Time frame: Up to 8 years
Time to a Sustained Reduction of Estimated Glomerular Filtration Rate (eGFR) >= 30% from Baseline
Time frame: Up to 8 years
Mean Change in T-score from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale at Week 104
Time frame: Baseline to Week 104
Duration of CR
Time frame: Up to 8 years
Change in anti-PLA2R Autoantibody Titer
Time frame: Baseline to Week 52
Mean Change from Baseline in the PROMIS Global Assessment of Physical Health Scale at Week 104
Time frame: Baseline to Week 104
Percentage of Participants with Adverse Events (AEs)
Time frame: Up to 8 years
Percentage of Participants with AEs of Special Interest (AESIs)
Time frame: Up to 8 years
Peripheral B-cell Counts at Specified Timepoints
Time frame: Weeks 0 (baseline), 2, 4, 12, 24, 26, 36, 52, 64, 76, 88, 104, 117, 130, 156, 182, 208 and every 26 weeks thereafter
Serum Concentrations of Obinutuzumab at Specified Timepoints
Time frame: Weeks 0 (baseline), 2, 4, 12, 24, 26, 36, 52, 64, 76, 88, 104, 117, 130, 143, 156, 169, 182, 195, 208, every 26 weeks thereafter
Prevalence of Anti-drug Antibodies (ADAs) to Obinutuzumab at Baseline
Time frame: Open Label: Baseline; Escape Treatment: Week 0
Incidence of ADAs during the study
Time frame: Weeks 2, 4, 12, 24, 26, 36, 52, 64, 76, 88, 104, 130, 156, 182, 208 and every 26 weeks thereafter
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 1 Oct 2026.
- Derived from this study: PubMed 42246654Fervenza FC, Hou FF, Hao CM, Kirsztajn GM, Gesualdo L, Hryszko T, Pisani A, Roccatello D, Bomback AS, Rae J, Barmaki F, Berisha E, Schindler T, Omachi TA, Garg JP, Malvar A; MAJESTY Trial Investigators. Obinutuzumab or Tacrolimus in Primary Membranous Nephropathy. N Engl J Med. 2026 Jun 5. doi: 10.1056/NEJMoa2602678. Online ahead of print.
- Derived from this study: PubMed 37678236Dossier C, Bonneric S, Baudouin V, Kwon T, Prim B, Cambier A, Couderc A, Moreau C, Deschenes G, Hogan J. Obinutuzumab in Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome in Children. Clin J Am Soc Nephrol. 2023 Dec 1;18(12):1555-1562. doi: 10.2215/CJN.0000000000000288. Epub 2023 Sep 6.
- Derived from this study: PubMed 33693991Dossier C, Hogan J. Response to Majeranowski. Pediatr Nephrol. 2021 Jun;36(6):1653. doi: 10.1007/s00467-021-04982-4. Epub 2021 Mar 10. No abstract available.
- Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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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. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
50 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Obinutuzumab, Tacrolimus and Methylprednisolone in people with Primary Membranous Nephropathy, run by Hoffmann-La Roche at 50 sites in 11 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 12 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: under way, not looking for participants, as of the sponsor's last update on 1 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 50 sites in China, United States, Italy, Poland, Spain and 6 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants who Achieve a Complete Remission (CR) at Week 104 (time frame: Week 104). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04629248, which also lists 3 linked publications.
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 1 Oct 2026.