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Systemic Lupus ErythematosusPhase 2NCT06570798

A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases

A Phase 2 study testing Inebilizumab and Blinatumomab in people with Systemic Lupus Erythematosus and Active Refractory Rheumatoid Arthritis, run by Amgen at 58 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The main objective is to assess the safety and tolerability of inebilizumab in adult participants with active and refractory systemic lupus erythematosus (SLE) with nephritis (Subprotocol A) and to assess the safety and tolerability of subcutaneous (SC) blinatumomab in adult participants with active and refractory SLE… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Inebilizumab and Blinatumomab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
58 sitesin 10 countries
Study dates
16 Jul 2025to 6 Aug 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subprotocol A and B: Diagnosis of SLE according to 2019 European League Against Rheumatism and the American College of Rheumatology (ACR) classification criteria.
  • Subprotocol A and B: Participant must be positive for at least one of the following autoantibodies at screening (performed by central laboratory) or through documented history:
  • Antinuclear antibodies (ANA) ≥ 1:80
  • Anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibodies elevated to above normal range (ie, positive results)
  • AntiSmith antibodies elevated to above normal (ie, positive results).
  • Subprotocol A and B (Subgroup 1): Active, biopsy-proven, proliferative LN demonstrating class III or class IV with or without co-existing features of Class V LN (or pure Class V LN for Subprotocol B only) according to 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria. The local biopsy report will be used.
Show all 29Show fewer
  • Subprotocol A and B: SLE Disease Activity Index 2K ≥ 6.
  • Subprotocol A and B (Subgroup 1): Inadequate response, loss of response or intolerance to at least 1 therapy (Subprotocol A) or 2 immunosuppressive therapies (Subprotocol B Subgroup 1) at the maximally tolerated doses as recommended by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines (KDIGO, 2024). Inadequate response is defined as: UPCR ≥ 1.0 mg/mg.
  • Subprotocol B (Subgroup 2): Refractory SLE participants with inadequate response to multiple therapies (excluding hydroxychloroquine or corticosteroids) and have failed either a biologic agent or cyclophosphamide.
  • Subprotocol B (Part B Subgroup 2): British Isles Lupus Assessment Group (BILAG)-2004 level A disease in 1 organ system or BILAG-2004 level B disease in ≥ 2 organ systems
  • Subprotocol B (Part B Subgroup 2): Physician Global Assessment (PGA) ≥ 1
  • Subprotocol A and B: If receiving any of the following medications, participants must be on these doses prior to Day 1:
  • Prednisone dose ≤ 20 mg/day (or its equivalent in other corticosteroid forms) and at a stable dose for 5 days
  • Hydroxychloroquine dose ≤ 400 mg/day and at a stable dose for 4 weeks. Other equivalent antimalarials (chloroquine, quinacrine) are also accepted at a stable dose for 4 weeks.
  • MMF dose ≤ 3 g/day or MPA dose ≤ 2160 mg/day and at a stable dose for 2 weeks.
  • AZA dose ≤ 2 mg/kg/day and at a stable dose for 2 weeks.
  • Methotrexate > 25 mg/week and at a stable dose for 2 weeks
  • Leflunomide > 20 mg/day and at a stable dose for 2 weeks
  • Dapsone > 300 mg/day and at a stable dose for 2 weeks.
  • Subprotocol C (Part A and Part B): Diagnosis of RA according to the 2010 ACR/European Alliance of Associations for Rheumatology (EULAR) classification criteria.
  • Subprotocol C (Part A and Part B): Moderate to severe disease activity as defined by DAS28-CRP > 3.2 with ≥ 3 swollen joints and ≥ 3 tender joints (based on 28 joint counts) at screening.
  • Subprotocol C (Part A and Part B): Refractory disease defined as:
  • Active disease despite having received treatment with:
  • at least 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD), AND
  • at least 2 biologic disease-modifying antirheumatic drugs (bDMARDs) of different mechanisms of action OR 1 bDMARD and at least 1 targeted synthetic disease-modifying antirheumatic drugs (tsDMARD).
  • Inadequate response or intolerance to csDMARDs, bDMARDs, and tsDMARDs should be defined as:
  • Participant having active disease despite a minimum of 12 weeks of treatment with a csDMARD, bDMARD, or tsDMARD.
  • Intolerance to treatment as defined by participant having experienced an adverse effect from treatment with a csDMARD, bDMARD, or tsDMARD.
  • Subprotocol C (Part B): High sensitivity C-Reactive Protein (hsCRP) level ≥ upper limit of normal per the central laboratory at screening.

Who cannot join

  • Subprotocol A, B and C: Receipt of a live and/or live attenuated vaccine within 4 weeks prior to first dose of trial drug, during the treatment period, or until B-cell repletion after the end of the treatment period. Administration of inactivated (killed) vaccines is acceptable.
  • Subprotocol A and B: Estimated glomerular filtration rate (eGFR) of < 30 mL per minute per 1.73 m^2 of body surface area (calculated using the Modification of Diet in Renal Disease [MDRD] formula, with screening laboratory results for serum creatinine value).
  • Subprotocol A and B: Significant likely irreversible organ damage related to SLE (eg, end-stage renal disease [ESRD]).
  • Subprotocol A and B: Any acute, severe lupus related flare during screening that needs immediate treatment.
  • Subprotocol A and B: A previous kidney transplant or planned transplant within trial treatment period.
  • Subprotocol A and B: History of or current renal diseases (Parts A and B, Subgroup 1) that in the opinion of the investigator could interfere with the LN assessment and confound the disease activity assessment (eg, diabetic nephropathy).
Show all 17Show fewer
  • Subprotocol A: Renal biopsy showing pure class V.
  • Subprotocol B: Active CNS Lupus within one year prior to screening.
  • Subprotocol B and C: History or presence of clinically relevant central nervous system (CNS) pathology or event such as seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, or organic brain syndrome.
  • Subprotocol C: Prior history of current inflammatory joint disease other than RA including but not limited to SLE, mixed connective tissue disorder, scleroderma, polymyositis, or significant systemic involvement secondary to RA (eg, vasculitis, pulmonary fibrosis, or Felty's syndrome).
  • Subprotocol C: Functional Class IV as defined by the ACR classification of functional status in RA.
  • Subprotocol A, B and C: Receipt of the following medications or treatments at any time prior to Day 1:
  • B-cell directed CAR T-cell and T-cell engager therapies
  • Total lymphoid irradiation
  • Bone marrow transplant
  • T-cell vaccination therapy
  • Natalizumab

Trial locations and contacts

58 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Amgen Call Center contact

866-572-6436

medinfo@amgen.com

58 sites in 10 countries

United States18 sites, 13 recruiting

  • University of Colorado

    Aurora, Colorado, 80045

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Recruiting

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

    Recruiting

  • The Metro Health System Main Campus

    Cleveland, Ohio, 44109

    Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Recruiting

  • Northwell Health

    Great Neck, New York, 11021

    Recruiting

  • Westchester Medical Center

    Hawthorne, New York, 10532

    Completed

  • Vida Research Center

    Hialeah, Florida, 33010

    Terminated

  • Homestead Associates In Research Inc

    Homestead, Florida, 33033

    Terminated

  • Prolato Clinical Research Center

    Houston, Texas, 77054

    Completed

  • Vitaly Clinical Research

    Miami, Florida, 33125

    Terminated

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

    Recruiting

  • Columbia University Medical Center

    New York, New York, 10032

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Recruiting

  • University of Rochester Medical Center

    Rochester, New York, 14642

    Recruiting

  • HonorHealth Research and Innovation Institute

    Scottsdale, Arizona, 85258

    Recruiting

  • Seattle Rheumatology Associates

    Seattle, Washington, 98104

    Recruiting

  • Bioresearch Partner Coral Terrace

    South Miami, Florida, 33143

    Recruiting

Other trials in United States

France12 sites, 11 recruiting

  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270

    Recruiting

  • Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez

    Lille, 59037

    Recruiting

  • Centre Hospitalier Universitaire de Lyon- Hopital Edouard Herriot

    Lyon, 69437

    Recruiting

  • Centre Hospitalier Universitaire de Lyon - Hopital Edouard Herriot

    Lyon Cédex 3, 69437

    Recruiting

  • Hopital de la Conception

    Marseille, 13005

    Recruiting

  • Hopital Cochin

    Paris, 75014

    Recruiting

  • Hopital Bichat Claude Bernard

    Paris, 75018

    Terminated

  • Hopital Europeen Georges Pompidou

    Paris, 75908

    Recruiting

  • Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil

    Strasbourg, 67091

    Recruiting

  • Centre Hospitalier Universitaire de Strasbourg - Hopital de Hautepierre

    Strasbourg, 67098

    Recruiting

  • Centre Hospitalier Universitaire de Toulouse - Hopital Purpan

    Toulouse, 31059

    Recruiting

  • Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

    Toulouse, 31059

    Recruiting

Other trials in France

Spain6 sites, 4 recruiting

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035

    Recruiting

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, Catalonia, 08036

    Recruiting

  • Hospital Universitari Vall d Hebron

    Barcelona, 08035

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Terminated

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

    Terminated

Other trials in Spain

Belgium4 sites, 4 recruiting

  • Cliniques Universtaire Saint Luc Universite Catholique de Louvain

    Brussels, 1200

    Recruiting

  • Universitair Ziekenhuis Gent

    Ghent, 9000

    Recruiting

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, 3000

    Recruiting

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liège, 4000

    Recruiting

Other trials in Belgium

Germany4 sites, 3 recruiting

  • Krankenhaus Porz am Rhein gGmbH

    Cologne, 51149

    Recruiting

  • Universitaetsklinikum Duesseldorf AoeR

    Düsseldorf, 40225

    Recruiting

  • Universitaetsklinikum Leipzig

    Leipzig, 04103

    Recruiting

  • Klinikum der LMU Muenchen

    München, 80336

    Completed

Other trials in Germany

United Kingdom4 sites, 4 recruiting

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ

    Recruiting

  • Western General hospital

    Edinburgh, EH4 2XU

    Recruiting

  • Leicester General Hospital

    Leicester, LE5 4PW

    Recruiting

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE7 7DN

    Recruiting

Other trials in United Kingdom

Italy3 sites, 2 recruiting

  • IRCCS Ospedale San Raffaele

    Milan, 20132

    Terminated

  • IRCCS Istituto Clinico Humanitas

    Rozzano, 20089

    Recruiting

  • Ospedale San Giovanni Bosco

    Turin, 10154

    Recruiting

Other trials in Italy

Portugal3 sites, 3 recruiting

  • Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Santa Cruz

    Carnaxide, 2790-134

    Recruiting

  • Unidade Local de Saude de Sao Jose, EPE - Hospital Curry Cabral

    Vila Franca de Xira, 2600-076

    Recruiting

  • Unidade Local de Saude de Gaia-Espinho, EPE

    Vila Nova de Gaia, 4430-502

    Recruiting

Other trials in Portugal

United Arab Emirates3 sites, 3 recruiting

  • Sheikh Shakhbout Medical City

    Abu Dhabi, 11001

    Recruiting

  • Cleveland Clinic Abu Dhabi

    Abu Dhabi

    Recruiting

  • Al Kuwait Hospital Dubai ehs

    Dubai, 22241

    Recruiting

Other trials in United Arab Emirates

Australia1 site, 1 recruiting

  • Linear Clinical Research Limited

    Perth, Western Australia, 6009

    Recruiting

Other trials in Australia

About this study

Official title: A Phase 2, Open Label, Multicenter, Platform Trial to Assess the Safety, Tolerability, and Efficacy of Inebilizumab and Blinatumomab in Subjects With Autoimmune Diseases

The main objective is to assess the safety and tolerability of inebilizumab in adult participants with active and refractory systemic lupus erythematosus (SLE) with nephritis (Subprotocol A) and to assess the safety and tolerability of subcutaneous (SC) blinatumomab in adult participants with active and refractory SLE with and without nephritis (Subprotocol B Part A) and in adult participants with active refractory rheumatoid arthritis (RA) (Subprotocol C Part A). The trial will also assess the efficacy of SC blinatumomab in adult participants with active and refractory SLE with and without nephritis (Subprotocol B Part B and Subprotocol C Part B).

Being tested
Inebilizumab, Blinatumomab
Keywords
Systemic lupus erythematosus, Inebilizumab, Blinatumomab, Active refractory rheumatoid arthritis, Rheumatoid arthritis
Medical subject headings
Lupus Erythematosus, Systemic, Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InebilizumabDrug

    Also called Uplizna®

    IV Infusion

  • BlinatumomabDrug

    SC Injection

Study groups in NCT06570798
Study groupRoleWhat they receive
Subprotocol A: Inebilizumab 3 DosesExperimentalParticipants will receive 3 doses of inebilizumab administered via an intravenous (IV) infusion.
Receives: Drug: Inebilizumab
Subprotocol A: Inebilizumab 4 DosesExperimentalParticipants will receive 4 doses of inebilizumab administered via an IV infusion.
Receives: Drug: Inebilizumab
Subprotocol B Part A: Blinatumomab Low-doseExperimentalParticipants will receive blinatumomab low-dose administered via SC injection.
Receives: Drug: Blinatumomab
Subprotocol B Part A: Blinatumomab Medium-doseExperimentalParticipants will receive blinatumomab medium-dose administered via SC injection.
Receives: Drug: Blinatumomab
Subprotocol B Part A: Blinatumomab High-doseExperimentalParticipants will receive blinatumomab high-dose administered via SC injection.
Receives: Drug: Blinatumomab
Subprotocol B Part B: Dose ExpansionExperimentalParticipants will receive blinatumomab at a dose which will be determined during Subprotocol B Part A.
Receives: Drug: Blinatumomab
Subprotocol C Part A: Blinatumomab Low-doseExperimentalParticipants will receive blinatumomab low-dose administered via SC injection during Subprotocol C Part A.
Receives: Drug: Blinatumomab
Subprotocol C Part A: Blinatumomab Medium-doseExperimentalParticipants will receive blinatumomab medium-dose administered via SC injection during Subprotocol C Part A.
Receives: Drug: Blinatumomab
Subprotocol C Part A: Blinatumomab High-doseExperimentalParticipants will receive blinatumomab high-dose administered via SC injection during Subprotocol C Part A.
Receives: Drug: Blinatumomab
Subprotocol C Part B: Dose ExpansionExperimentalParticipants will receive blinatumomab at a dose which will be determined during Subprotocol C Part A.
Receives: Drug: Blinatumomab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subprotocol A, B Part A, and C Part A: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)

    Measured: Day 1 to Week 52

  2. Subprotocol A, B Part A, and C Part A: Number of Participants Who Experience a Serious TEAE

    Measured: Day 1 to Week 52

  3. Subprotocol B Part B Subgroup 1: Number of Participants With Complete Renal Response (CRR)

    Measured: Week 52

  4. Subprotocol B Part B Subgroup 2: Number of Participants With Remission in SLE as Defined by Definition of Remission in SLE (DORIS)

    Measured: Week 26

  5. Subprotocol C Part B: Percentage of Participants Achieving Disease Activity Score-28 Joint C-Reactive Protein (DAS28-CRP) Remission

    Measured: Week 12

Secondary outcomes (31)

  1. Subprotocol A, B Part A Subgroup 1 and Part B Subgroup 1: Number of Participants With CRR

    Measured: Subprotocol A and B Part A: Week 12, Week 26, Week 38, and Week 52; Subprotocol B Part B: Week 12, Week 26, and Week 38

  2. Subprotocol A, B Part A Subgroup 1 and Part B Subgroup 1: Number of Participants With Partial Renal Response (PRR)

    Measured: Week 12, Week 26, Week 38, and Week 52

  3. Subprotocol A and B: Number of Participants With Remission in SLE as Defined by DORIS

    Measured: Subprotocol A, B Part A, and B Part B Subgroup 1: Week 12, Week 26, Week 38, and Week 52; Subprotocol B Part B Subgroup 2: Week 12, Week 38, and Week 52

  4. Subprotocol A and B: Number of Participants With a Lupus Low Disease Activity State (LLDAS)

    Measured: Week 12, Week 26, Week 38, and Week 52

  5. Subprotocol A and B: Change From Baseline in SLE Activity Index-2000 (SLEDAI-2K) Score

    Measured: Week 12, Week 26, Week 38, and Week 52

  6. Subprotocol A, B Part A Subgroup 1 and Part B Subgroup 1: Change From Baseline in 24-hour UPCR

    Measured: Week 12, Week 26, Week 38, and Week 52

  7. Subprotocol A: Maximum Concentration (Cmax) of Inebilizumab

    Measured: Day 1 to Week 52

  8. Subprotocol A: Time to Cmax (tmax) of Inebilizumab

    Measured: Day 1 to Week 52

  9. Subprotocol A: Area Under the Concentration-time Curve (AUC) of Inebilizumab

    Measured: Day 1 to Week 52

  10. Subprotocol B and C: Cmax of Blinatumomab

    Measured: up to Week 12

  11. Subprotocol B and C: tmax of Blinatumomab

    Measured: up to Week 12

  12. Subprotocol B and C: AUC of Blinatumomab

    Measured: up to Week 12

  13. Subprotocol A: Number of Participants With Anti-inebilizumab Antibody Formation

    Measured: Day 1 to Week 52

  14. Subprotocol B and C: Number of Participants With Anti-blinatumomab Antibody Formation

    Measured: Day 1 to Week 52

  15. Subprotocol C Part A: Percentage of Participants Achieving DAS28-CRP < 2.6

    Measured: Week 12 and Week 26

  16. Subprotocol C Part A: Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) ≤ 2.8

    Measured: Week 12 and Week 26

  17. Subprotocol C Part A: Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) ≤ 3.3

    Measured: Week 12 and Week 26

  18. Subprotocol C: Percentage of Participants Achieving American College of Rheumatology (ACR)20 response

    Measured: Week 12 and Week 26

  19. Subprotocol C: Percentage of Participants Achieving ACR50 Response

    Measured: Week 12 and Week 26

  20. Subprotocol C: Percentage of Participants Achieving ACR70 Response

    Measured: Week 12 and Week 26

  21. Subprotocol B Part B and C Part B: Number of Participants Who Experience a TEAE

    Measured: Day 1 to Week 52

  22. Subprotocol B Part B and C Part B: Number of Participants Who Experience a Serious TEAE

    Measured: Day 1 to Week 52

  23. Subprotocol B Part A Subgroup 1 and Part B Subgroup 1: Number of Participants With Primary Efficacy Renal Response (PERR)

    Measured: Week 12, Week 26, Week 38, and Week 52

  24. Subprotocol B Part B Subgroup 2: Number of Participants Who are Responders as Defined by SLE Responder Index 4 (SRI-4)

    Measured: Week 12, Week 26, Week 38, and Week 52

  25. Subprotocol B Part B Subgroup 2: Number of Participants Who are Responders as Defined by SRI-6

    Measured: Week 12, Week 26, Week 38, and Week 52

  26. Subprotocol B Part B Subgroup 2: Number of Participants Who are Responders as Defined by SRI-8

    Measured: Week 12, Week 26, Week 38, and Week 52

  27. Subprotocol B Part B Subgroup 2: Number of Participants Who are Responders as Defined by BILAG-based Combined Lupus Assessment (BICLA)

    Measured: Week 12, Week 26, Week 38, and Week 52

  28. Subprotocol C Part B: Percentage of Participants Achieving DAS28-CRP Remission at Week 26

    Measured: Week 26

  29. Subprotocol C Part B: Percentage of Participants Achieving CDAI Remission at Weeks 12 and 26

    Measured: Week 12 and Week 26

  30. Subprotocol C Part B: Percentage of Participants Achieving SDAI Remission at Weeks 12 and 26

    Measured: Week 12 and Week 26

  31. Subprotocol C Part B: Percentage of Participants Who Achieve DAS28-CRP Remission at Week 12 and Sustain Remission at Weeks 26, 38, and 52

    Measured: Week 12, Week 26, Week 38, and Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2024
  2. Study start16 Jul 2025
  3. Primary completion6 Aug 2028 (estimated)
  4. Study completion6 Aug 2028 (estimated)

Resources

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
Non-randomised
Intervention model
Sequential
Model description
Subprotocol A: Sequential study model Subprotocol B: Sequential study model Subprotocol C: Sequential study model
Masking
None (open label)
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06570798
Sponsor's protocol ID
20240033
Other IDs
2024-514382-19
Status last verified
Sep 2026
First submitted
22 Aug 2024
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Publications

  • Karam S, Boudhabhay I, Jhaveri KD. Bispecific Antibodies for Glomerular Diseases: Are We Ready for Prime Time? J Am Soc Nephrol. 2026 Apr 14. doi: 10.1681/ASN.0000001120. Online ahead of print. No abstract available.

    PubMed 41979896

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Inebilizumab and Blinatumomab in people with Systemic Lupus Erythematosus and Active Refractory Rheumatoid Arthritis, run by Amgen at 58 sites in 10 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 29 inclusion and 17 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 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 58 sites in United States, France, Spain, Belgium, Germany and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subprotocol A, B Part A, and C Part A: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE) (time frame: Day 1 to Week 52). The study lists 5 primary outcomes in all. 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 NCT06570798, which also lists 1 linked publication.

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 Oct 2026; AzTrials last refreshed its copy on 1 Nov 2026.

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