Primary Membranous NephropathyPhase 3PROMINENTNCT06962800
A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN)
A Phase 3 study testing Felzartamab and Tacrolimus in people with Primary Membranous Nephropathy, run by Biogen at 114 sites in 11 countries.
Trial summary
In this study, researchers will learn more about the use of felzartamab in participants with primary membranous nephropathy, also known as PMN. In people with PMN, autoantibodies build up in the glomeruli of the kidney. Antibodies are proteins that help the body fight off infection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Membranous Nephropathy
- What is being tested?
- Felzartamab and Tacrolimus
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 114 sitesin 11 countries
- Study dates
- 22 May 2025to 17 Jan 2031
- Phase
- Phase 3
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with PMN in need of IST according to the Investigator's clinical judgment. The diagnosis of PMN must be documented with the presence of nephrotic syndrome, and hypoalbuminemia, and confirmed with a kidney biopsy either during Screening or within 5 years of signing the informed consent form (ICF) [see kidney biopsy exception below for participants positive for anti-PLA2R antibodies]. For these participants, the biopsy report with redacted protected health information must be available to be reviewed by the Sponsor or an independent nephropathologist. If the participant requires a kidney biopsy during Screening, medical monitor approval must be obtained, and all other eligibility criteria should be reviewed to ensure that the participant is otherwise eligible prior to performing the kidney biopsy.
- Kidney biopsy exception for anti-PLA2R antibody positive participants: Participants who are positive for anti-PLA2R antibodies at Screening and have not had a kidney biopsy performed within 5 years of signing the ICF may be eligible for the study without undergoing a kidney biopsy based on medical monitor review of screening tests confirming normal estimated glomerular filtration rate (eGFR), presence of nephrotic syndrome, hypoalbuminemia, positive anti-PLA2R antibody test (defined as an anti-PLA2R antibody titer ≥ 20 RU/mL), and documentation provided by the Investigator that the work-up for secondary causes of membranous nephropathy (MN) was negative with no identifiable secondary causes.
- Meets one of the following:
- Newly diagnosed PMN, defined as having never received IST for PMN in the past.
- Relapsed PMN, defined as documented achievement of CR or partial remission (PR) after treatment with an IST for PMN followed by reappearance of nephrotic range proteinuria (urine protein to creatinine ratio [UPCR] ≥ 3.0 gram per gram [g/g] from a 24-hour urine collection or proteinuria ≥ 3.5 gram per 24 hour [g/24 h]).
- Participants must be on the maximally approved dose or maximally tolerated dose of at least one renin-angiotensin-aldosterone system (RAAS) inhibition therapy (e.g. angiotensin-converting enzyme inhibitor [ACEI], angiotensin receptor blocker [ARB], and/or mineralocorticoid receptor antagonists [MRA]) for at least 4 weeks prior to Screening. Participants not on the maximally approved dose of RAAS inhibition may be enrolled provided there is documented intolerance to maximal RAAS inhibition (e.g., angioedema, development of postural hypotension, lightheadedness, hyperkalemia, etc). Participants on MRA therapy alone at Screening must have documented prior intolerance of ACEI or ARB therapy. Participants who do not tolerate ACEI or ARB therapy are not required to start MRA therapy prior to Screening.
- A UPCR of ≥ 3.0 g/g (as determined by a 24-hour urine collection) or total proteinuria ≥ 3.5 g/24 h (as determined by a 24-hour urine collection) at Screening after best supportive care for at least 4 weeks prior to signing the ICF.
Who cannot join
- Secondary cause of MN (e.g., malignancies, medications, systemic lupus erythematosus [SLE], hepatitis B, hepatitis C, etc).
- Severe renal impairment is defined as an eGFR ≤ 30 mL/min/1.73m^2 at Screening or including the need for dialysis or renal replacement therapy.
- Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
114 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
Global Biogen Clinical Trial Center contact
114 sites in 11 countries
China32 sites, 32 recruiting
- Recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
- Recruiting
Daqing Oilfield General Hospital
Daqing, Heilongjiang, 163001
- Recruiting
Fu Yang People's Hospital - South Campus
Fuyang, Anhui, 236006
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280
- Recruiting
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550004
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine - Qingchun Campus - PPDS
Hangzhou, Zhejiang, 310003
- Recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
- Recruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Qingchun Campus
Hangzhou, Zhejiang, 310016
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
- Recruiting
The Second Hospital of Shandong University
Jinan, Shandong, 250033
- Recruiting
Gansu Provincial Hospital
Lanzhou, Gansu, 730000
- Recruiting
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030
- Recruiting
The First Affiliated Hospital of Henan Science and Technology University - Jinghua Campus
Luoyang, Henan, 471003
- Recruiting
The Second Affiliated Hospital of Nanjing Medical University - Main Campus
Nanjing, Jiangsu, 210011
- Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
- Recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021
- Recruiting
The First Affiliated Hospital of Ningbo University - Yuehu Campus
Ningbo, Zhejiang, 315010
- Recruiting
The Affiliated Hospital of Qingdao University - Xihaian Campus
Qingdao, Shandong, 266555
- Recruiting
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
- Recruiting
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040
- Recruiting
Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, 510086
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
- Recruiting
The Second Hospital of Hebei Medical University - Main
Shijiazhuang, Hebei, 50000
- Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 50031
- Recruiting
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710004
- Recruiting
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061
- Recruiting
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361004
- Recruiting
Peking University First Hospital - Changqiao Campus
Xichengqu Beijing, Beijing Municipality, 100034
- Recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000
- Recruiting
Yichang Central People's Hospital - Wujiagang Campus
Yichang, Hubei, 443003
- Recruiting
Yueyang People Hospital
Yueyang, Hunan, 414000
United States16 sites, 15 recruiting
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106-1716
440-951-3500, andrew.lazar@uhhospitals.com
Lazar, Andrew
- Recruiting
Nephrotex Research Group
Dallas, Texas, 75231-0929
214-396-4950
Sumit Kumar
- Recruiting
Henry Ford Hospital- A-Basement Research Pharmacy
Detroit, Michigan, 48202-2608
313-900-2298
Douglas Atchison
- Recruiting
The Nephrology Group, Inc. - Fresno
Fresno, California, 93720-2989
559-228-6600 ext. 8706
Yangming Cao
- Recruiting
ECU Physicians Nephrology and Hypertension
Greenville, North Carolina, 27834
252-744-2545, obir@ecu.edu
Reginald Obi
- Recruiting
Apogee Clinical Research, LLC
Huntsville, Alabama, 35805-4104
256-533-4626
Michael Quadrini
- Recruiting
Knoxville Kidney Center, PLLC
Knoxville, Tennessee, 37923-3624
865-692-3462
George Newman
- Recruiting
University of Texas Medical Branch
League City, Texas, 77573
409-772-2473
Shikha Wadhwani
- Recruiting
Academic Medical Research Institute
Los Angeles, California, 90022
323-725-0051
Mohamed El-Shahawy
- Recruiting
UCLA Health Connie Frank Kidney Transplant Center and General Nephrology
Los Angeles, California, 90095-8344
310-794-5024
Anjay Rastogi
- Recruiting
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53792-0001
608-265-0631
Sarah Panzer
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37204-3609
615-936-1179
Neil Sanghani
- Completed
Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS
Pontiac, Michigan, 48341
- Recruiting
UCSF Medical Center
San Francisco, California, 94143-2205
415-353-7900
Christopher Carlos
- Recruiting
Stanford University
Stanford, California, 94305-2200
650-721-4011
Fahmeedah Kamal
- Recruiting
James J Peters Veterans Administration Medical Center - NAVREF - PPDS
The Bronx, New York, 10468
718-584-9000 ext. 2158
Chang Xu
India12 sites, 12 recruiting
- Recruiting
Manipal Hospital Bangalore
Bangalore, Karnataka, 560017
- Recruiting
M.S. Ramaiah Medical College and Hospital
Bangalore, Karnataka, 560054
- Recruiting
Postgraduate Institute of Medical Education & Research (PGIMER)
Chandigarh, 160012
- Recruiting
Osmania General Hospital
Hyderabad, Andhra Pradesh, 500012
- Recruiting
Nizams Institute of Medical Sciences
Hyderabad, Andhra Pradesh, 500082
- Recruiting
Nil Ratan Sircar Medical College and Hospital
Kolkata, West Bengal, 700014
- Recruiting
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, 226014
- Recruiting
Regency Health Super Specialty Hospital - Lucknow
Lucknow, Uttar Pradesh, 226022
- Recruiting
Max Super Speciality Hospital - Saket
New Delhi, National Capital Territory of Delhi, 110017
- Recruiting
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060
- Recruiting
Noble Hospital
Pune, Maharashtra, 411013
- Recruiting
Galaxy Hospital - Varanasi
Varanasi, Uttar Pradesh, 221010
Japan12 sites, 12 recruiting
- Recruiting
National Hospital Organization Chiba Medical Center Chibahigashi National Hospital
Chia-shi, Chiba, 260-8712
- Recruiting
Saitama Medical University Hospital
Iruma-Gun Moroyama-Machi, Saitama, 350-0451
- Recruiting
Kagawa University Hospital
Kita-Gun Uchiko-Cho, Kagawa-ken, 761-0793
- Recruiting
University of Miyazaki Hospital
Miyazaki, Miyazaki, 889-1692
- Recruiting
Japanese Red Cross Musashino Hospital
Musashino-shi, Tokyo, 180-8610
- Recruiting
Niigata University Medical ＆ Dental Hospital
Niigata, Niigata, 951-8520
- Recruiting
The Kitasato Institute Kitasato University Hospital
Sagamihara-Shi Minami-Ku, Kanagawa, 252-0375
- Recruiting
Hokkaido University Hospital
Sapporo, Hokkaidô, 060-8648
- Recruiting
The University of Osaka Hospital
Suita-Shi, Osaka, 565-0871
- Recruiting
Social Medical Corporation Yuuaikai Yuuai Medical Center
Tomigusuku-Shi, Okinawa, 901-0224
- Recruiting
Juntendo University Urayasu Hospital
Urayasu-Shi, Chiba, 279-0021
- Recruiting
Yokohama City University Hospital
Yokohama, Kanagawa, 236-0004
Australia10 sites, 10 recruiting
- Recruiting
Monash Health
Clayton, Victoria, 3168
- Recruiting
Concord Hospital
Concord, New South Wales, 2138
- Recruiting
Townsville Hospital
Douglas, Queensland, 4814
- Recruiting
Royal Brisbane and Women s Hospital
Herston, Queensland, 4006
- Recruiting
St George Hospital
Kogarah, New South Wales, 2217
- Recruiting
Liverpool Hospital
Liverpool, New South Wales, 2170
- Recruiting
Gold Coast University Hospital
Southport, Queensland, 4215
- Recruiting
Griffith University Clinical Trial Unit
Southport, Queensland, 4215
- Recruiting
Sunshine Hospital - Australia
St Albans, Victoria, 3021
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Taiwan10 sites, 10 recruiting
- Recruiting
Hualien Tzu Chi Hospital
Hualien City, Hualien, 970
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
- Recruiting
China Medical University Hospital
Taichung, 40447
- Recruiting
Taichung Veterans General Hospital
Taichung, 40705
- Recruiting
National Cheng Kung University Hospital
Tainan, 70403
- Recruiting
MacKay Memorial Hospital
Taipei, 104
- Recruiting
Taipei Medical University Hospital - PPDS
Taipei, 11031
- Recruiting
Taipei Municipal Wanfang Hospital
Taipei, 116
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, 33305
Brazil7 sites, 7 recruiting
- Recruiting
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, Minas Gerais, 30150-221
55319422796
Pedro Augusto Macedo de Souza
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90560-030
555134000000
Cristina Karohl
- Recruiting
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Porto Alegre, Rio Grande do Sul, 90610-001
555134000000, giovani.gadonski@pucrs.br
Giovani Gadonski
- Recruiting
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
Ribeirão Preto, São Paulo, 14051-140
551640000000
Gustavo Misiara
- Recruiting
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
São José do Rio Preto, São Paulo, 15090-000
551732000000
Fernanda Cristina Camelo Sanches
- Recruiting
Hospital Alemao Oswaldo Cruz (HAOC)
São Paulo, 01327-001
551135000000
Victor Sato
- Recruiting
Centro de Pesquisa Clínica de Nefrologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 05304-000
551127000000
Irene Noronha
Argentina5 sites, 5 recruiting
- Recruiting
Organización Médica de Investigación
Buenos Aires, C1015ABO
5491160000000, avmperrin@yahoo.com.ar
Ana Malvar Perrin
- Recruiting
CINME S.A. - Centro de Investigaciones Metabólicas
Buenos Aires, C1056ABI
548889000000
Fernando Halac
- Recruiting
Hospital Italiano de Buenos Aires
Buenos Aires, C1199ABB
541150000000
Carlos Varela
- Recruiting
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, C1425
541134723300
Mria Smuclir Quevedo
- Recruiting
Clínica Privada Vélez Sarsfield
Córdoba, X5016KET
5403514432121
Rafael Maldonado
South Korea5 sites, 5 recruiting
- Recruiting
Inje University Haeundae Paik Hospital
Busan, 48108
- Recruiting
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 3080
- Recruiting
Hanyang University Seoul Hospital
Seoul, 4763
- Recruiting
Chung-Ang University Hospital
Seoul, 6973
- Recruiting
Ajou University Hospital
Suwon, Gyeonggido, 16499
Malaysia3 sites, 3 recruiting
- Recruiting
Hospital Canselor Tuanku Muhriz UKM
Cheras, WilayahPersekutuan KualaLumpur, 56000
- Recruiting
Prince Court Medical Centre
Kuala Lumpur, 50450
- Recruiting
Hospital Raja Permaisuri Bainun
Perak, Pahang, 30450
Canada2 sites, 2 recruiting
- Recruiting
London Health Sciences Centre - Victoria Hospital
London, Ontario, N6A 5W9
5196858066, susan.huang@lhsc.on.ca
Huang, Susan (Shih-Han)
- Recruiting
Vancouver Coastal Health Research Institute
Vancouver, British Columbia, V5Z 1M9
6048754323
Sean Barbour
About this study
Official title: An Open-Label, Multicenter, Randomized Phase 3 Study Evaluating the Efficacy and Safety of Felzartamab in Participants With Primary Membranous Nephropathy (PMN) [PROMINENT]
In this study, researchers will learn more about the use of felzartamab in participants with primary membranous nephropathy, also known as PMN. In people with PMN, autoantibodies build up in the glomeruli of the kidney. Antibodies are proteins that help the body fight off infection. An autoantibody is a type of antibody that mistakenly targets and attacks the body's own tissues. Glomeruli are the filters of the kidney that remove waste and extra fluid from the body. In PMN, the build-up of autoantibodies in the glomeruli causes damage to the kidneys.
Kidney damage can lead to too much protein and blood leaking into the urine. High levels of protein in the urine, called proteinuria, are common in people with PMN. Symptoms of PMN can include swelling in the legs and body, tiredness, and high blood pressure. If left untreated, PMN can eventually lead to kidney failure.
Read more
In this study, researchers will learn more about how a study drug called felzartamab affects people with PMN. Felzartamab is a monoclonal antibody, which means it is an antibody made in a laboratory. Felzartamab can target immune cells that produce autoantibodies, helping to lower their buildup in the kidneys. The main goal of this study is to compare how felzartamab works compared to a drug called tacrolimus. Tacrolimus is another drug given to people with PMN and kidney disease.
The main question that researchers want to answer is:
- How many participants achieve a complete response after 104 weeks of treatment?
- A complete response means that their urine protein levels decrease to a low level and their kidney function remains stable.
Researchers will also learn about:
- How long it takes before the participants' disease gets worse
- How long the participants' urine protein levels stay low
- How many participants develop antibodies against felzartamab in the blood?
- How many participants achieve a complete response after 76 weeks of treatment
- How many participants have medical problems during the study
- How felzartamab is processed by the body
- How felzartamab affects participants' tiredness and overall physical health
The study will be done as follows:
- Participants will be screened to check if they can join the study. This may take up to 42 days.
- Participants will be randomized to receive either felzartamab as intravenous (IV) infusions or tacrolimus, taken orally as tablets.
- If participants have worsening kidney function or worsening proteinuria, or if their PMN relapses, or if they show no signs of improvement in their PMN, they will have a chance to receive rescue treatment.
- If a participant stops treatment early, there will be follow-up visits every 12 weeks until they reach Week 104.
- In total, participants will have up to 23 study visits. Participants who do not need rescue treatment will stay in the study for up to 104 weeks. Participants who need rescue treatment will stay in the study for up to 156 weeks.
Read the detailed description
The primary objective of the study is to assess the efficacy of felzartamab compared to tacrolimus in participants with PMN in achieving complete remission (CR) of proteinuria. The secondary objectives of the study are to evaluate the efficacy of felzartamab through additional clinical endpoints and timepoints, to assess the impact of felzartamab on serum anti-phospholipase A2 receptor (PLA2R) antibodies and patient-reported outcomes, and to assess the safety, pharmacokinetics (PK) and immunogenicity of felzartamab.
- Conditions
- Primary Membranous Nephropathy
- Being tested
- Felzartamab, Tacrolimus, Standard of Care IST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FelzartamabDrug
Also called MOR202, MOR03087, TJ202, BIIB148, HIB202
Administered intravenously
TacrolimusDrug
Administered orally
Standard of Care ISTDrug
Administered intravenously and orally
| Study group | Role | What they receive |
|---|---|---|
| Open-Label Treatment Phase | Experimental | Participants will receive several intravenous (IV) doses of felzartamab or oral tacrolimus in the Open-Label Treatment Phase. Receives: Drug: Felzartamab; Drug: Tacrolimus |
| Non-Responder Treatment Phase | Experimental | Participants initially randomized to felzartamab or tacrolimus who meet rescue criteria may receive regional standard of care immunosuppressive therapy (IST) per Investigator discretion or several IV doses of felzartamab, respectively, in the Non-Responder Treatment Phase. Receives: Drug: Felzartamab; Drug: Standard of Care IST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants who Achieve Complete Remission (CR) at Week 104
Measured: Week 104
Secondary outcomes (12)
Percentage of Participants who Achieve Overall Remission (OR), Defined as CR or Partial Remission (PR) at Week 104
Measured: Week 104
Percentage of Participants who Achieve CR at Week 76
Measured: Week 76
Duration of CR
Measured: Baseline up to Week 156
Percentage of Participants With a Baseline Anti-Phospholipase A2 Receptor (PLA2R) Autoantibody Titer Greater Than 50 Relative Unit per Milliliter (RU/mL) who Achieve an OR at Week 76 and at Week 104
Measured: Weeks 76 and 104
Time to Disease Worsening
Measured: Baseline up to Week 156
Time to a Sustained Reduction in eGFR of ≥ 30% From Baseline
Measured: Baseline up to Week 104
Absolute Change in Anti-PLA2R Autoantibody Titer in Participants Positive for Anti-PLA2R at Baseline
Measured: Baseline up to Week 156
Change From Baseline in the Patient Reported Outcome Measurement Information System (PROMIS) Fatigue Scale at Week 104
Measured: Week 104
Change From Baseline in PROMIS Global Assessment of Physical Health Scale at Week 104
Measured: Week 104
Number of Participants With Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE) and Adverse Events of Special Interest (AESIs)
Measured: From first dose of study drug up to end of follow-up (up to Week 156)
Felzartamab Serum Concentrations Over Time
Measured: Predose and at multiple timepoints post dose up to Week 156
Number of Participants With Anti-Drug Antibodies (ADAs) Against Felzartamab
Measured: Predose and at multiple timepoints post dose up to Week 156
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start22 May 2025
- Primary completion28 Jan 2030 (estimated)
- Study completion17 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Membranous NephropathyStudies of the same condition, open and under way.
- More trials run by BiogenThe 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962800
- Sponsor's protocol ID
- 299PN301
- Other IDs
- 2024-519232-16-00
- Acronym
- PROMINENT
- Status last verified
- Sep 2026
- First submitted
- 30 Apr 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/