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CompletedNCT03157635COMPOSERUpdated Sep 1, 2026

Study to Assess Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Healthy Volunteers and Participants With Paroxysmal Nocturnal Hemoglobinuria

A Phase 1/2 interventional study of Crovalimab and Placebo in Paroxysmal Hemoglobinuria, Nocturnal, sponsored by Hoffmann-La Roche. Completed at 15 sites in 7 countries. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Hoffmann-La Roche · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This is a Phase I/II, first-in-human study consisting of four sequential parts and an open-label extension (OLE). The safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single doses of crovalimab will be evaluated in healthy volunteers (HV) during part 1. The safety, tolerability, PK and PD of multiple doses of crovalimab will be evaluated in participants with paroxysmal nocturnal hemoglobinuria (PNH) in parts 2, 3, 4, and OLE of the study. Efficacy of crovalimab will be evaluated in Parts 2, 3, and 4.

02

Conditions studied

  • Paroxysmal Hemoglobinuria, Nocturnal
03

In context

Hemoglobinuria, Paroxysmal

188 studies on the registry are indexed under Hemoglobinuria, Paroxysmal; 48 are open to participants now.

This study's enrollment of 59 is above the median of 34 across 147 interventional studies indexed under Hemoglobinuria, Paroxysmal.

Browse Hemoglobinuria, Paroxysmal studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Part 1 (HVs only):

  • Healthy male volunteers, aged between 21 and 55 years inclusive
  • Participants with a negative hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C antibody, and human immunodeficiency virus (HIV) test result
  • Participants who have been vaccinated against hepatitis B
  • No evidence of Neisseria meningococci in nasopharyngeal swab
  • Neisseria meningitidis vaccination against serogroups B and A, C, W, and Y
  • Non-smokers, or former smokers, who have not smoked for at least 60 days prior to screening

Parts 2, 3 and 4 (PNH participants only):

  • Male or female participants with PNH between 18 and 75 years of age
  • Neisseria meningitidis vaccination in accordance with most current local guidelines or standard of care (SOC) for participants at increased risk for meningococcal disease (Part 2 and 4)
  • Participant has been vaccinated with Neisseria meningitidis vaccine(s) in accordance with most current local guidelines or SOC for participants at increased risk for meningococcal disease or is being revaccinated if applicable (Part 3 and 4)
  • Antibiotic prophylaxis for meningococcal infection must be initiated prior to initiation of crovalimab therapy if the time period between initial Neisseria meningitidis vaccination and first dose of crovalimab is less than 2 weeks (Part 2 and 4)
  • Antibiotic prophylaxis of meningococcal infection may be initiated prior to initiation of crovalimab therapy based on local guidelines or SOC for participants at increased risk for meningococcal disease e.g., splenectomized patients (Parts 2 and 4)
  • Stable dose for greater than or equal to (>/=) 28 days prior to screening of other therapies (immunosuppressant therapy, corticosteroids, iron supplements)

Part 2 and 4 (currently untreated PNH participants who are candidates for treatment with complement inhibitors only):

  • PNH participants who have not been treated with any complement inhibitor or if previously treated stopped treatment due to lack of efficacy based on a single missense C5 heterozygous mutation
  • Serum LDH levels at least 1.5-fold above the ULN at screening
  • Hepatitis B participants can be enrolled if their liver function test values are less than 2 x ULN and there is no liver function impairment

Part 3 and 4 (PNH participants currently treated with eculizumab only):

  • PNH participants who have been treated continuously with eculizumab for at least 3 months preceding enrollment in the trial
  • Participants receive regular infusions of eculizumab
  • Subjects with a negative hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C antibody, and HIV test result

OLE only - PNH participants:

  • PNH participants who have completed Parts 2, 3 and 4 respectively
  • PNH participants who derived, in the investigator's opinion, benefit from treatment with crovalimab
  • Vaccination currency for Neisseria meningitidis serotypes A, C, W, Y and B should be maintained throughout the OLE

All Parts:

  • Female participants should use proper means of contraception

Exclusion criteria

Exclusion Criteria:

Part 1 (HVs only):

  • Any clinically relevant history or the presence of moderate to severe respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, or connective tissue disease
  • Any major illness within 1 month before the screening
  • Prior splenectomy
  • History of clinically significant hypersensitivity (example: drugs, excipients) or allergic reactions
  • History or presence of clinically significant electrocardiogram (ECG) abnormalities or cardiovascular disease
  • Any contra-indication for receiving Neisseria meningitides vaccination and antibiotic prophylaxis therapy as required in the study
  • Congenital or acquired complement deficiency
  • Carriers of Neisseria meningitides based on cultures from nasopharyngeal swabs
  • Known active viral, bacterial or fungal infection including herpes, herpes zoster or cold sores, during the last 14 days prior to first study drug administration
  • Signs of parasitic infection (example: eosinophilia, diarrhea)
  • History of significant recurrent infections in the opinion of the investigator

Parts 2, 3 and 4 - PNH participants only:

  • Evidence of moderate to severe concurrent renal, liver, cardiac, pulmonary or gastrointestinal disease not related to PNH as determined by the investigator
  • History of an illness that, in the opinion of the study investigator, might confound the results of the study or that poses an additional risk to the participant by his or her participation in the study
  • History of bone marrow transplantation
  • Treatment with azathioprine or erythrocyte-stimulating agents within 14 days prior to first study drug administration
  • Splenectomy \<1 year before start of crovalimab.

Part 3 and 4 - PNH patients only:

  • Any evidence of sero-positive auto-immune connective tissue diseases (such as systemic lupus erythematosus, or rheumatoid arthritis)
  • Any evidence of active inflammatory conditions (including inflammatory bowel disease, or cryoglobulinemia)

All Parts:

  • Under active therapy with intravenous immunoglobulin (IVIG)
  • Mentally incapacitated or history of a clinically significant psychiatric disorder over the previous 5 years
  • Known or suspected hereditary complement deficiency
  • History of meningococcal meningitis
  • History of allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies or known hypersensitivity to any constituent of the product
  • Any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 28 days prior to screening or oral antibiotics within 2 weeks prior to screening and up to first study drug administration
  • History of or currently active primary or secondary immunodeficiency, including known history of human immunodeficiency virus (HIV) infection
  • Evidence of chronic active hepatitis C infection
  • Evidence of malignant disease including myelodysplastic syndrome, or malignancies diagnosed within the previous 5 years
  • Pregnant or breastfeeding, or intending to become pregnant during the study, including the OLE period, within 46 weeks (approximately 10.5 months) after the final dose of crovalimab
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
59 participants (actual)

Study arms

  • Experimental
    Part 1 (Healthy Volunteers): Crovalimab

    Healthy participants will receive a single dose of crovalimab in each dose-escalation cohort of Part 1. Crovalimab will be administered at a starting dose of 75 milligrams (mg) intravenous (IV) infusion. Doses are planned to be escalated up to Cohort 5.

    Drug: Crovalimab

  • Placebo comparator
    Part 1 (Healthy Volunteers): Placebo

    Healthy participants will receive a single dose of crovalimab matching placebo in each dose-escalation cohort of Part 1.

    Drug: Placebo

  • Experimental
    Part 2 (PNH Participants): Crovalimab

    PNH participants will receive 3 single ascending doses (375 mg IV, 500 mg IV, 1000 mg IV of crovalimab) on Days 1, 8, and 22 followed by weekly crovalimab administrations up to a maximum of 5 months. Weekly crovalimab administrations will start no earlier than Day 36. The starting dose of Part 2 is based on data from Part 1 of the study.

    Drug: Crovalimab

  • Experimental
    Part 3 (PNH Participants): Crovalimab QW

    Participants will receive crovalimab at a dose of 1000 mg on Day 1 and 170 mg weekly (QW) starting on Day 8 for a maximum treatment duration of 5 months.

    Drug: Crovalimab

  • Experimental
    Part 3 (PNH Participants): Crovalimab Q2W

    Participants will receive crovalimab at a dose of 1000 mg on Day 1 and 340 mg every 2 weeks (Q2W) for a maximum treatment duration of 5 months.

    Drug: Crovalimab

  • Experimental
    Part 3 (PNH Participants): Crovalimab Q4W

    Participants will receive crovalimab at a dose of 1000 mg on Day 1 and 680 mg every 4 weeks (Q4W) starting on Day 8 for a maximum treatment duration of 5 months.

    Drug: Crovalimab

  • Experimental
    Part 4 (eculizumab pretreated PNH Participants): Crovalimab

    PNH Participants pretreated with eculizumab will receive crovalimab: Participants \>/= 100 kilograms (kg): loading dose of 1500 mg IV on Day 1; Participants \< 100 kg: loading dose of 1000 mg IV on Day 1. In all Participants, the remainder of the loading series schedule will be 340 mg subcutaneous (SC) on Days 2, 8, 15, and 22. For Participants \>/= 100 kg, maintenance dosing will be 1020 mg SC on week 5 and then Q4W thereafter. Patients \< 100 kg will receive a maintenance dose of 680 mg SC on the same schedule.

    Drug: Crovalimab

  • Experimental
    Part 4 (treatment naïve PNH Participants): Crovalimab

    Treatment naïve PNH Participants will receive: Participants \>/= 100 kg: loading dose of 1500 mg IV on day 1; Participants \< 100 kg: loading dose of 1000 mg IV on day 1. In all Participants, the remainder of the loading series schedule will be 340 mg SC on Days 2, 8, 15, and 22. For Participants \>/= 100 kg, maintenance dosing will be 1020 mg SC on week 5 and then Q4W thereafter. Patients \< 100 kg will receive a maintenance dose of 680 mg SC on the same schedule.

    Drug: Crovalimab

  • Experimental
    OLE (PNH Participants): Crovalimab

    PNH Participants who participated in Parts 2, 3 and 4 and who derive clinical benefit from crovalimab may enroll into OLE. Participants will either receive 680 mg SC Q4W (body weight \>/= 40 kg to \< 100 kg) or 1020 mg SC Q4W (body weight \>/= 100 kg) for up to a maximum treatment duration of ten years from entry into OLE.

    Drug: Crovalimab

Interventions

  • DrugCrovalimab

    Crovalimab will be administered as per schedule described in individual arm.

  • DrugPlacebo

    Placebo will be administered as per schedule described in Part 1 placebo arm.

06

What researchers measure

Primary outcomes

  1. Part 1: Percentage of Participants With Dose-Limiting Events (DLEs)

    Time frame: Baseline up to approximately 3 months

  2. Part 1: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Baseline up to approximately 3 months

  3. Part 2: Percentage of Participants With AEs and SAEs

    Time frame: Baseline up to approximately 8 months

  4. Part 3: Percentage of Participants With AEs and SAEs

    Time frame: Baseline up to approximately 8 months

  5. Part 4: Percentage of Participants With AEs and SAEs

    Time frame: Baseline up to approximately 8 months

  6. Part 2: Terminal Complement Activity in Serum as Assessed by Ex Vivo Liposome Immunoassay (LIA)

    Time frame: Baseline up to Day 224

  7. Part 3: Terminal Complement Activity as Assessed by Ex Vivo Liposome Lysis in Serum Using the LIA

    Time frame: Baseline up to Day 224

  8. Part 4: Terminal Complement Activity in Serum as Assessed by Ex Vivo Liposome Immunoassay (LIA)

    Time frame: Baseline up to Day 224

  9. OLE: Percentage of Participants With AEs and SAEs

    Time frame: OLE: Week 21 up to Week 567

Secondary outcomes

  1. Part 1: Terminal Complement Activity as Assessed by Ex Vivo Liposome Immunoassay (LIA)

    Time frame: Part 1: Baseline up to Day 91 (assessed at predose [Hour 0], end of infusion [EOI] [1 Hour], Hours 2, 6, 12 on Day 1; Days 2, 3, 4, 5, 7, 14, 21, 28, 35, 42, 56, 91)

  2. Part 2: Serum Lactate Dehydrogenase (LDH) Levels

    Time frame: Predose (Hour 0), Hours 10-12 on Days 1, 8; Days 2, 5, 9, 15, 22, 29, 36, 43, 50, 64, 78, 92, 106, 120, 134, 224

  3. Part 3: Serum LDH Levels

    Time frame: Part 3: Predose (Hour 0), Hours 10-12 on Day 1; predose (Hour 0), on Days 2, 8, 15, 22, 29, 36, 64, 78, 92, 106, 134; Day 224

  4. Part 4: Serum LDH Levels

    Time frame: Part 4: Predose (Hour 0), Hour 6 on Day 1; predose (Hour 0), on Days 2, 8, 15, 22, 29, 43, 57, 85, 113, 134; Day 224

  5. Part 1: Total Complement Component 5 (C5) Concentration

    Time frame: Part 1: Predose (Hour 0), EOI (1 Hour), Hours 2, 6, 12 on Day 1; Days 2, 3, 4, 5, 7, 14, 21, 28, 35, 42, 56, 91

  6. Part 2: Total C5 Concentration

    Time frame: Part 2: Predose (Hour 0), EOI (1 Hour), Hours 2, 6, 10-12 on Day 1; Days 2, 5, 9, 15, 29, 224; predose [Hour 0], EOI [1 Hour], Hours 10-12 on Days 8, 22; predose [Hour 0] on Days 36, 43, 50, 64, 78, 92, 106, 120, 134

  7. Part 3: Total C5 Concentration

    Time frame: Part 3: Predose (Hour 0), EOI (1 Hour), Hours 2 and 6 on Day 1; predose (Hour 0), on Days 2, 8, 15, 22, 29, 36, 43, 50, 57, 64, 78, 92, 106; Day 224

  8. Part 4: Total C5 Concentration

    Time frame: Part 4: Predose (Hour 0), EOI (1 Hour), Hours 2, 6 on Day 1; predose (Hour 0), on Days 2, 8, 15, 22, 29, 57, 85, 113; Days 43, 134, 224

  9. Part 1: Free C5 Concentration

    Time frame: Part 1: Predose (Hour 0), EOI (1 Hour), Hours 2, 6, 12 on Day 1; Days 2, 3, 4, 5, 7, 14, 21, 28, 35, 42, 56, 91

  10. Part 2: Free C5 Concentration

    Time frame: Part 2: Predose (Hour 0), EOI (1 Hour), Hours 2, 6, 10-12 on Day 1; Days 2, 5, 9, 15, 29, 224; predose [Hour 0], EOI [1 Hour], Hours 10-12 on Days 8, 22; predose [Hour 0] on Day 36, 43, 50, 64, 78, 92, 106, 120, 134

  11. Part 3: Free C5 Concentration

    Time frame: Part 3: Predose (Hour 0), EOI (1 Hour), Hours 2, 6 on Day 1; predose (Hour 0), on Days 2, 8, 15, 22, 29, 36, 43, 50, 57, 64, 78, 92, 106; Day 224

  12. Part 4: Free C5 Concentration

    Time frame: Part 4: Predose (Hour 0), EOI (1 Hour), Hours 2, 6 on Day 1; predose (Hour 0), on Days 2, 8, 15, 22, 29, 57, 85, 113; Days 43, 134, 224

  13. Part 2: Change From Baseline in Fatigue as Measured by Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score at Day 64

    Time frame: Baseline, Day 64

  14. Part 3: Change From Baseline in Fatigue as Measured by FACIT-Fatigue Scale Score at Day 8, 22, 50, 78, 106, and 134

    Time frame: Baseline, Day 8, 22, 50, 78, 106, 134

  15. Part 4: Change From Baseline in Fatigue as Measured by FACIT-Fatigue Scale Score at Day 8, 22, 57, 85, 113 and 134

    Time frame: Baseline, Day 8, 22, 57, 85, 113, 134

  16. Part 2: Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Score at Day 64

    Time frame: Baseline, Day 64

  17. Part 3: Change From Baseline in HRQoL as Measured by EORTC QLQ-C30 Score at Day 78 and 134

    Time frame: Baseline, Day 78, 134

  18. Part 4: Change From Baseline in HRQoL as Measured by EORTC QLQC30 Score at Day 85 and 134

    Time frame: Baseline, Day 85, 134

  19. Part 2: Participant Treatment Satisfaction as Measured by Treatment Satisfaction Questionnaire for Medication (TSQM) Score at Day 8, 22, 36, 50 and 64

    Time frame: Baseline, Day 8, 22, 36, 50, 64

  20. Part 3: Participant Treatment Satisfaction as Measured by TSQM Score at Day 8 and 50

    Time frame: Baseline, Day 8, 50

  21. Part 4: Participant Treatment Satisfaction as Measured by TSQM Score at Day 8 and 57

    Time frame: Baseline, Day 8, 57

  22. Part 2: Number of Packed Red Blood Cell (RBC) Units Transfused per Participant

    Time frame: Baseline up to Day 224

  23. Part 3: Number of Packed RBCs Units Transfused per Participant

    Time frame: Baseline up to Day 224

  24. Part 4: Number of Packed RBCs Units Transfused per Participant

    Time frame: Baseline up to Day 224

  25. Part 2: Percentage of Participants With Packed RBC Units Transfused

    Time frame: Baseline up to Day 224

  26. Part 3: Percentage of Participants With Packed RBC Units Transfused

    Time frame: Baseline up to Day 224

  27. Part 4: Percentage of Participants With Packed RBC Units Transfused

    Time frame: Baseline up to Day 224

  28. Part 1: Percentage of Participants With Anti-Drug Antibodies (ADAs) to Crovalimab

    Time frame: Part 1: Day 1 up to Day 91 (assessed at predose [Hour 0] on Day 1; on Days 14, 28, 56, 84, and 91)

  29. Part 2: Percentage of Participants With ADAs to Crovalimab

    Time frame: Part 2: Day 1 up to Day 224 (assessed at predose [Hour 0] on Days 1, 8, 50, 106, 134); Days 29, 224

  30. Part 3: Percentage of Participants With ADAs to Crovalimab

    Time frame: Part 3: Day 1 up to Day 106 assessed at predose [Hour 0] on Days 1, 8, 29, 64, and 106; Day 224

  31. Part 4: Percentage of Participants With ADAs to Crovalimab

    Time frame: Day 1 up to Day 224 (assessed at predose [Hour 0] on Days 1, 8, 29, 113); Days 134, 224

  32. OLE: Total C5 Concentration

    Time frame: OLE: Predose (Hour 0) on Week 36 up to Week 521

  33. OLE: Serum LDH Levels

    Time frame: OLE: Predose (Hour 0) on Week 28 up to Week 521

  34. OLE: Terminal Complement Activity in Serum as Assessed by Ex Vivo Liposome Immunoassay (LIA)

    Time frame: OLE: Week 36 up to Week 521

  35. Part 2: Percentage of Participants With LDH Below Upper Limit of Normal (ULN)

    Time frame: Baseline up to Day 224

  36. Part 3: Percentage of Participants With LDH Below ULN

    Time frame: Baseline up to Day 224

  37. Part 4: Percentage of Participants With LDH Below ULN

    Time frame: Baseline up to Day 224

  38. Part 2: Percentage of Participants With Complement Suppression

    Time frame: Baseline up to Day 134

  39. Part 3: Percentage of Participants With Complement Suppression

    Time frame: Baseline up to Day 134

  40. Part 4: Percentage of Participants With Complement Suppression

    Time frame: Baseline up to Day 134

  41. Part 2: Monthly Rate of pRBC Transfusions per Participant

    Time frame: Baseline up to 10 years

  42. Part 3: Monthly Rate of pRBC Transfusions per Participant

    Time frame: Baseline up to 10 years

  43. Part 4: Monthly Rate of pRBC Transfusions per Participant

    Time frame: Baseline up to 10 years

  44. Part 2: Proportion of Transfusion-Free Participants

    Time frame: Baseline up to 10 years

  45. Part 3: Proportion of Transfusion-Free Participants

    Time frame: Baseline up to 10 years

  46. Part 4: Proportion of Transfusion-Free Participants

    Time frame: Baseline up to 10 years

  47. Part 2: Annual Rate of Transfusion Avoidance per Participant

    Time frame: Baseline up to 10 years

  48. Part 3: Annual Rate of Transfusion Avoidance per Participant

    Time frame: Baseline up to 10 years

  49. Part 4: Annual Rate of Transfusion Avoidance per Participant

    Time frame: Baseline up to 10 years

  50. Part 2: Annual Rate of Breakthrough Hemolysis (BTH)

    Time frame: Baseline up to 10 years

  51. Part 3: Annual Rate of Breakthrough Hemolysis (BTH)

    Time frame: Baseline up to 10 years

  52. Part 4: Annual Rate of Breakthrough Hemolysis (BTH)

    Time frame: Baseline up to 10 years

07

Study locations

15 sites
  • Institut hematologie Centre Hayem CHU paris Saint-Louis Lariboisiere F Widal Hopital St Louis
    Paris, 75475, France
  • Uniklinik RWTH Aachen
    Aachen, 52074, Germany
  • Universitätsklinikum Essen
    Essen, 45122, Germany
  • Universitätsklinikum Ulm
    Ulm, 89081, Germany
  • Semmelweis Egyetem, 1. Szamu Belgyogyaszati Klinika, Diabetologia
    Budapest, 1083, Hungary
  • Kaposi Mor Teaching Hospital, Dept of Internal Medicine/Hematology
    Kaposvár, 7400, Hungary
  • Policlinico Universitario Agostino Gemelli
    Rome, Lazio 00168, Italy
  • Tohoku University Hospital
    Miyagi, 980-8574, Japan
  • Osaka University Hospital
    Osaka, 565-0871, Japan
  • NTT Medical Center Tokyo
    Tokyo, 141-8625, Japan
  • Tokyo Medical University Hospital
    Tokyo, 160-0023, Japan
  • University of Tsukuba Hospital
    Tsukuba, 305-8576, Japan
  • Pra International Group B.V
    Groningen, 9713 GZ, Netherlands
  • Severance Hospital, Yonsei University Health System
    Seoul, 03722, South Korea
  • Seoul National University Hosp
    Seoul, 110-744, South Korea
08

References and documents

Publications

  • Roth A, Nishimura JI, Nagy Z, Gaal-Weisinger J, Panse J, Yoon SS, Egyed M, Ichikawa S, Ito Y, Kim JS, Ninomiya H, Schrezenmeier H, Sica S, Usuki K, Sicre de Fontbrune F, Soret J, Sostelly A, Higginson J, Dieckmann A, Gentile B, Anzures-Cabrera J, Shinomiya K, Jordan G, Biedzka-Sarek M, Klughammer B, Jahreis A, Bucher C, Peffault de Latour R. The complement C5 inhibitor crovalimab in paroxysmal nocturnal hemoglobinuria. Blood. 2020 Mar 19;135(12):912-920. doi: 10.1182/blood.2019003399. PubMed 31978221 ↗

Individual participant data

Plan to share: Yes — Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical -trials/data-sharing/)

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03157635
Lead sponsor
Hoffmann-La Roche
Collaborators
Chugai Pharmaceutical
Responsible party
Sponsor
First posted
May 17, 2017
Start date
Nov 14, 2016
Primary completion
Aug 13, 2026
Completion
Aug 13, 2026
Last update
Sep 1, 2026

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

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