Microvascular InflammationPhase 2TRANSPIRENCT07219043
A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
A Phase 2 study testing Felzartamab in people with Microvascular Inflammation, run by Biogen at 53 sites in 11 countries.
Trial summary
In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and later developed a condition called microvascular inflammation (MVI). MVI is a type of injury to small blood vessels in the transplanted kidney and may be a sign of rejection by the body. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Microvascular Inflammation
- What is being tested?
- Felzartamab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 53 sitesin 11 countries
- Study dates
- 5 Jan 2026to 10 Feb 2028
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MVI (MVI ≥2), donor specific antibody (DSA)-negative that is either complement activation (C4d) negative or C4d positive (biopsy-confirmed) without T cell-mediated rejection (TCMR) per central reading, as defined by the Banff 2022 criteria.
- Biopsy must be prior to randomization.
- For participants who received any prior treatment for antibody-mediated rejection (AMR) or MVI, the biopsy must be performed after completing (or stopping) prior treatment.
- Kidney transplant prior to Screening visit (recipients of either living or deceased donors).
Who cannot join
- Transplant: Blood type (ABO)-incompatible transplant.
- History of multiple organ transplants including en bloc and dual kidney transplants.
- Acute, rapid decline in renal function, defined as a participant likely to require renal replacement therapy within the next 30 days as determined by the Investigator.
- Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
53 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
Global Biogen Clinical Trial Center contact
53 sites in 11 countries
United States25 sites, 25 recruiting
- Recruiting
University of Michigan Medical Center
Ann Arbor, Michigan, 48109-5650
734-936-6381
Mona Doshi
- Recruiting
University of Colorado
Aurora, Colorado, 80045
720-848-0860
James Coooper
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
773-702-1220
Beatrice Concepcion
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
216-444-5383
Emilio Poggio
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
614-293-4997
Todd Pesavento
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
617-724-9673
David Wojciechowski
- Recruiting
Duke University Hospital
Durham, North Carolina, 27710
919-681-2533
Scott Sanoff
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
713-441-6174
Osama Gaber
- Recruiting
The University of Kansas Medical Center
Kansas City, Kansas, 66160
913-574-0084
Diane Cibrik
- Recruiting
Loma Linda University Medical Center
Loma Linda, California, 92350
909-558-3722
Rafael Villicana
- Recruiting
Keck Hispital of University of Southern California (USC)
Los Angeles, California, 90033
800-872-2273
Thin Thin Maw
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
310-423-2641
Edmund Huang
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
310-794-8516
Suphamai Brunnapradist
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
414-805-6060
Matthew Cooper
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
615-322-6976
Tony Langone
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
402-559-9235
Eric Langewisch
- Recruiting
Providence St. Joseph Hospital Orange
Orange, California, 92868
714-771-8000
Yasir Qazi
- Recruiting
Penn Medicine - Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
215-614-4274
Roy Bloom
- Recruiting
Virginia Commonwealth University (VCU) Medical Center (Main Hospital) Hume-Lee Transplant Center
Richmond, Virginia, 23298
804-828-1855
Gaurav Gupta
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
507-266-6953
Carrie Schinstock
- Recruiting
Sutter Health - California Pacific Medical Center
San Francisco, California, 94115
415-600-1063
Ram V. Peddi
- Recruiting
University of California San Fransisco (UCSF) Medical Center
San Francisco, California, 94158
412-518-0094
Puneet Sood
- Recruiting
University of Washington Medical Center
Seattle, Washington, 98195
206-598-5896
Nicolae Leca
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
314-362-8351
Tarek Alhamad
- Recruiting
Cooperman Barnabas Medical Center
West Orange, New Jersey, 07039
973-322-2146
Anup Patel
Spain5 sites, 5 recruiting
- Recruiting
Hospital Del Mar
Barcelona, 8003
34 932 483 162
Marta Crespo
- Recruiting
Hospital Universitario Vall d'Hebron
Barcelona, 8035
932 607 385 ext. +34
Oriol Bestard
- Recruiting
Hospital Clínic de Barcelona
Barcelona, 8036
+34 932 275 444
Fritz Diekmann
- Recruiting
Hospital Universitario de Bellvitge
Barcelona, 8907
34 932 607 385
Edoardo Melilli
- Recruiting
Hospital Universitario Miguel Servet
Zaragoza, 50009
+34 976 765 624
Alex Gutiérrez Dalmau
Australia4 sites, 4 recruiting
- Recruiting
Princess Alexandra Hospital
Brisbane, Queensland, 4102
- Recruiting
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
- Recruiting
Royal Melbourne Hospital
Parkville, Victoria, 3050
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
France4 sites, 4 recruiting
- Recruiting
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Pellegrin
Bordeaux, 33000
+33 5 56 79 55 38
Lionel Couzi
- Recruiting
Centre Hospitalier Universitaire (CHU) de GreNble Alpes - Hôpital Michallon
La Tronche, 38700
0033 5 56 79 55 38
Lionel Rostaing
- Recruiting
Hospices Civils de Lyon - Hôpital Édouard Herriot
Lyon, 69003
+334 2785 8000
Oliver Thaunat
- Recruiting
Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital de Rangueil
Toulouse, 31400
33 561 323 200
Nassim Kamar
Germany4 sites, 4 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, 10117
49 30 450 514002
Klemens Budde
- Recruiting
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, 1307
0049 351 458 4233
Christian Hugo
- Recruiting
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20251
407410 52240 ext. +49 (0)
Florian Grahammer
- Recruiting
Universitätsklinikum Regensburg
Regensburg, 93053
49 (0) 40 7410 52240
Barnhard Banas
Brazil3 sites, 3 recruiting
- Recruiting
Hospital do Rim - Fundação Oswaldo Ramos
São Paulo, 04038-002
+55 11 5904-1699
Lúcio Moura
- Recruiting
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP)
São Paulo, 05403-900
11 2661 8089
David Elias Neto
- Recruiting
Hospital de Base da Faculdade de Medicina de São José do Rio Preto
Vila São José, São José Do Rio Preto, 15090-000
55(17) 3201-5054
Maria Alice Baptista
Canada3 sites, 3 recruiting
- Recruiting
Alberta Health Services (AHS) - University of Alberta Hospital
Edmonton, Alberta, T6G 2R3
(780) 492-2532
Sita Gourishankar
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
604-875-5950
James Lan
- Recruiting
Providence Health Care - St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
604-806-8970
John Gill
Argentina2 sites, 2 recruiting
- Recruiting
Instituto de Trasplante y Alta Complejidad (ITAC)
Buenos Aires, Ciudad Autónoma de Buenos Aires (caba), 1425
54 11 48022720
Carmen Rial
- Recruiting
Clínica Privada Vélez Sarsfield
Córdoba, 5000
54 35 1208 9560
Rafael Maldonado
Austria1 site, 1 recruiting
- Recruiting
Medizinische Universität Wien
Vienna, 1090
43 69917151086
Georg Boehmig
Czechia1 site, 1 recruiting
- Recruiting
Institut klinicke a experimentalni mediciny (IKEM)
Prague, 104 21
420 261 36 5390
Ondrej Viklicky
Switzerland1 site, 1 recruiting
- Recruiting
Universitätsspital Zürich
Zurich, 8091
+41 43 253 7614
Dusan Harmacek
About this study
Official title: A Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 2 Trial Evaluating the Efficacy and Safety of Felzartamab in Recipients of Kidney Transplants With Late Isolated Microvascular Inflammation (MVI)
In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and later developed a condition called microvascular inflammation (MVI). MVI is a type of injury to small blood vessels in the transplanted kidney and may be a sign of rejection by the body. It can lead to serious kidney problems over time.
In many cases, MVI is caused by antibodies that attack the transplanted kidney. But in some people, MVI happens without these antibodies. This type of MVI is called isolated MVI. There are currently no approved treatments for isolated MVI.
Read more
The main goal of the study is to learn about the effect felzartamab has on inflammation in the transplanted kidney. The main question researchers want to answer is:
- How many participants have no signs of active inflammation in the transplanted kidney after 24 weeks of treatment with felzartamab?
Researchers will also study how felzartamab affects kidney function, immune activity, and overall health. They will monitor safety through kidney biopsies, lab tests, and by recording adverse events throughout the study.
Adverse events are health problems that may or may not be caused by the study drug.
The study will be done in 2 parts as follows:
- Participants will be randomly assigned to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine.
- In Part A, participants will receive their assigned drug for 24 weeks. Neither the researchers nor the participants will know who is receiving felzartamab or placebo.
- Part B will last another 28 weeks. All participants will receive felzartamab and both participants and researchers will know this.
- All treatments will be given by intravenous (IV) infusion at the study site.
- Participants will have kidney biopsies at the start of the study, at Week 24, and at Week 52 to help measure changes in inflammation.
- Participants will stay in the study for about 1 year.
Read the detailed description
The primary objective of the study is to evaluate the efficacy of felzartamab compared to placebo in kidney transplant recipients in Cohort 1 (Part A). The secondary objectives of the study are to evaluate the efficacy of felzartamab compared to placebo through additional clinical endpoints (Part A), summarize efficacy of felzartamab up to Week 52 in kidney transplant recipients in Cohorts 1 and 2 (Part B); evaluate safety of felzartamab in kidney transplant recipients in Cohorts 1 and 2 (Parts A and B) and to assess the pharmacokinetic (PK) profile and immunogenicity of felzartamab (Parts A and B).
- Conditions
- Microvascular Inflammation
- Being tested
- Felzartamab, Placebo
- Keywords
- Kidney Transplant, Kidney Transplant Rejection
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, HIB202, BIIB148
Administered IV
PlaceboDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| Felzartamab | Experimental | Participants will receive multiple IV doses of felzartamab. Receives: Drug: Felzartamab |
| Placebo and Felzartamab | Placebo comparator | Participants will receive multiple IV doses of placebo followed by multiple doses of IV felzartamab. Receives: Drug: Felzartamab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Percentage of Participants Who Achieve Biopsy-proven Histologic Resolution (BPHR)
Measured: Week 24
Secondary outcomes (16)
Part A: Microvascular Inflammation (MVI) Score
Measured: Week 24
Part A: Percentage of Participants Who Achieve an MVI Score of 0
Measured: Week 24
Part A: Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Measured: Baseline, Week 24
Part A: Percentage of Participants in Cohort 2 Who Achieve BPHR
Measured: Week 24
Part B: Percentage of Participants Who Achieve BPHR
Measured: Weeks 24 and 52
Part B: MVI Score
Measured: Weeks 24 and 52
Part B: Percentage of Participants Who Achieve an MVI Score of 0
Measured: Weeks 24 and 52
Part B: Change from Baseline in eGFR
Measured: Baseline, Weeks 24 and 52
Part B: Time to All-cause Allograft Loss
Measured: Up to Week 52
Parts A and B: Number of Participants with Adverse Events (AEs)
Measured: From first dose of study drug up to end of study follow-up (up to week 57)
Parts A and B: Percentage of Participants with T Cell-mediated Rejection (TCMR) by Biopsy
Measured: Weeks 24 and 52
Parts A and B: Number of Participants with Clinically Significant Laboratory Abnormalities
Measured: From time of first dose to end of trial visit (Up to Week 52)
Parts A and B: Number of Participants with Clinically Significant Vital Signs Abnormalities
Measured: From time of first dose to end of trial visit (Up to Week 52)
Parts A and B: Number of Participants with Clinically Significant Electrocardiogram (ECG) Abnormalities
Measured: From time of first dose to end of trial visit (Up to Week 52)
Parts A and B: Felzartamab Serum Concentration
Measured: Up to Week 52
Parts A and B: Number of Participants with Anti-drug Antibodies (ADAs) Against Felzartamab
Measured: Baseline, up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2025
- Study start5 Jan 2026
- Primary completion10 Feb 2028 (estimated)
- Study completion10 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microvascular InflammationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 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
- NCT07219043
- Sponsor's protocol ID
- 299AR201
- Other IDs
- 2025-521742-15, 2025
- Acronym
- TRANSPIRE
- Status last verified
- Nov 2026
- First submitted
- 17 Oct 2025
- Last updated
- 5 Nov 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/
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 2 Trial Evaluating the Efficacy and Safety of Felzartamab in Recipients of Kidney Transplants With Late Isolated Microvascular Inflammation (MVI)
- ClinicalTrials.gov ID
- NCT07219043
- Acronym / sponsor ID
- TRANSPIRE / 299AR201
- Conditions
- Microvascular Inflammation
- Keywords
- Kidney Transplant, Kidney Transplant Rejection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 10 Feb 2028 (estimated)
- Study completion
- 10 Feb 2028 (estimated)
- First posted
- 21 Oct 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.
In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and later developed a condition called microvascular inflammation (MVI). MVI is a type of injury to small blood vessels in the transplanted kidney and may be a sign of rejection by the body. It can lead to serious kidney problems over time.
In many cases, MVI is caused by antibodies that attack the transplanted kidney. But in some people, MVI happens without these antibodies. This type of MVI is called isolated MVI. There are currently no approved treatments for isolated MVI.
The main goal of the study is to learn about the effect felzartamab has on inflammation in the transplanted kidney. The main question researchers want to answer is:
- How many participants have no signs of active inflammation in the transplanted kidney after 24 weeks of treatment with felzartamab?
Researchers will also study how felzartamab affects kidney function, immune activity, and overall health. They will monitor safety through kidney biopsies, lab tests, and by recording adverse events throughout the study.
Adverse events are health problems that may or may not be caused by the study drug.
The study will be done in 2 parts as follows:
- Participants will be randomly assigned to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine.
- In Part A, participants will receive their assigned drug for 24 weeks. Neither the researchers nor the participants will know who is receiving felzartamab or placebo.
- Part B will last another 28 weeks. All participants will receive felzartamab and both participants and researchers will know this.
- All treatments will be given by intravenous (IV) infusion at the study site.
- Participants will have kidney biopsies at the start of the study, at Week 24, and at Week 52 to help measure changes in inflammation.
- Participants will stay in the study for about 1 year.
Detailed description
The primary objective of the study is to evaluate the efficacy of felzartamab compared to placebo in kidney transplant recipients in Cohort 1 (Part A). The secondary objectives of the study are to evaluate the efficacy of felzartamab compared to placebo through additional clinical endpoints (Part A), summarize efficacy of felzartamab up to Week 52 in kidney transplant recipients in Cohorts 1 and 2 (Part B); evaluate safety of felzartamab in kidney transplant recipients in Cohorts 1 and 2 (Parts A and B) and to assess the pharmacokinetic (PK) profile and immunogenicity of felzartamab (Parts A and B).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Felzartamab | Experimental | Drug: FelzartamabParticipants will receive multiple IV doses of felzartamab. |
| Placebo and Felzartamab | Placebo comparator | Drug: Felzartamab, Drug: PlaceboParticipants will receive multiple IV doses of placebo followed by multiple doses of IV felzartamab. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- MVI (MVI ≥2), donor specific antibody (DSA)-negative that is either complement activation (C4d) negative or C4d positive (biopsy-confirmed) without T cell-mediated rejection (TCMR) per central reading, as defined by the Banff 2022 criteria.
- Biopsy must be prior to randomization.
- For participants who received any prior treatment for antibody-mediated rejection (AMR) or MVI, the biopsy must be performed after completing (or stopping) prior treatment.
- Kidney transplant prior to Screening visit (recipients of either living or deceased donors).
Key exclusion criteria (4 listed)
- Transplant: Blood type (ABO)-incompatible transplant.
- History of multiple organ transplants including en bloc and dual kidney transplants.
- Acute, rapid decline in renal function, defined as a participant likely to require renal replacement therapy within the next 30 days as determined by the Investigator.
- Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
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 |
|---|---|---|
| FelzartamabAlso: MOR202, MOR03087, TJ202, HIB202, BIIB148Administered IV | Drug | Felzartamab, Placebo and Felzartamab |
| PlaceboAdministered IV | Drug | Placebo and Felzartamab |
Primary outcome
Part A: Percentage of Participants Who Achieve Biopsy-proven Histologic Resolution (BPHR)
Time frame: Week 24
16 secondary outcomes
Part A: Microvascular Inflammation (MVI) Score
Time frame: Week 24
Part A: Percentage of Participants Who Achieve an MVI Score of 0
Time frame: Week 24
Part A: Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline, Week 24
Part A: Percentage of Participants in Cohort 2 Who Achieve BPHR
Time frame: Week 24
Part B: Percentage of Participants Who Achieve BPHR
Time frame: Weeks 24 and 52
Part B: MVI Score
Time frame: Weeks 24 and 52
Part B: Percentage of Participants Who Achieve an MVI Score of 0
Time frame: Weeks 24 and 52
Part B: Change from Baseline in eGFR
Time frame: Baseline, Weeks 24 and 52
Part B: Time to All-cause Allograft Loss
Time frame: Up to Week 52
Parts A and B: Number of Participants with Adverse Events (AEs)
Time frame: From first dose of study drug up to end of study follow-up (up to week 57)
Parts A and B: Percentage of Participants with T Cell-mediated Rejection (TCMR) by Biopsy
Time frame: Weeks 24 and 52
Parts A and B: Number of Participants with Clinically Significant Laboratory Abnormalities
Time frame: From time of first dose to end of trial visit (Up to Week 52)
Parts A and B: Number of Participants with Clinically Significant Vital Signs Abnormalities
Time frame: From time of first dose to end of trial visit (Up to Week 52)
Parts A and B: Number of Participants with Clinically Significant Electrocardiogram (ECG) Abnormalities
Time frame: From time of first dose to end of trial visit (Up to Week 52)
Parts A and B: Felzartamab Serum Concentration
Time frame: Up to Week 52
Parts A and B: Number of Participants with Anti-drug Antibodies (ADAs) Against Felzartamab
Time frame: Baseline, up to Week 52
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 5 Nov 2026.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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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.
Global Biogen Clinical Trial Center contact
Medical Director study director
Biogen
53 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Felzartamab in people with Microvascular Inflammation, run by Biogen at 53 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 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 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Spain, Australia, France, Germany 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. 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 US Biogen Clinical Trial Center (866-633-4636, clinicaltrials@biogen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Percentage of Participants Who Achieve Biopsy-proven Histologic Resolution (BPHR) (time frame: Week 24). 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 5 Nov 2026.