Protocol Explorer - BP30037 (Copy for Transcelerate)

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BP30037 (Copy for Transcelerate)

Status & Metadata

Source Method : Publicly Available

Source URL: Link

Generation Method : Unknown

Date Added: 16 Jun 2026

Contributor: System

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Additional Resources

Protocol

Date Added: 16 Jun 2026

CDISC CORE Conformance

Conformance assessed

SKIPPED 48

SUCCESS 144

ISSUE_REPORTED 10

EXECUTION_ERROR 5

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Rationale

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2A Study to Assess the Efficacy of RO5459072 in Patients With Primary Sjogren's Syndrome

Key Metrics

Study Type Interventional Study

Study Phase Phase II Trial

Protocol Version 1.0

Study ID c6f50208-5ea3-416c-b1db-55b5f072d67f

Important Dates

Event	Date
Protocol Approval	01 Jan 2024

Schedule of Activities: Main Study Design

Timeline: Main

Visit / Timing	Interval	Window	Activities
Screening & Baseline Day -1.0 TIM1	1 day	No window	Informed Consent Obtained IRT-Eligibility Checklist Demographics Medical History, General (Lifetime) Physical Exam Body Weight Vital Signs HCG Beta Subunit (Pregnancy Test) [Presence], Serum QuantiFERON-TB Gold Test, Blood HBV and HCV Screening and Diagnosis, Serum HIV 1+2 Ab [Presence], Serum EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) Rheumatoid Factor [Presence], Serum Cryoglobulin IgA+IgG+IgM+C3 Panel, Serum IgM [Mass/Vol], Serum IgG [Mass/Vol], Serum Nuclear Ab [Presence], Serum Sjogrens Syndrome-A ENA [Unit/Vol] by Immunoassay, Serum Sjogrens Syndrome-B ENA [Unit/Vol] by Immunoassay, Serum Chemistry Panel (CHEM-14), Serum or Plasma C Reactive Protein [Mass/Vol] by HSM, Serum or Plasma Creatine Kinase [Act/Vol], Serum or Plasma Gamma Glutamyl Transferase [Act/Vol], Serum or Plasma Phosphate [Mass/Vol], Serum or Plasma Troponin I Cardiac [Mass/Vol], Serum or Plasma Complement C3 and C4 Panel [Mass/Vol], Serum or Plasma CBC W Differential Panel by Unspecified Method, Blood Coagulation Panel (PT/INR, aPTT), Platelet poor plasma Lipid Panel (CHEM), Serum or Plasma Urinalysis Macro Panel by Dipstick, Urine 12 Lead ECG (Triplicate) Adverse Events Prior/Concomitant Medications
Treatment Day 14.0 TIM2	1 day	No window	IRT-Randomization IRT-Investigational Product Dispensation IRT-Eligibility Checklist HCG Beta Subunit (Pregnancy Test) [Presence], Serum HCG Beta Subunit (Pregnancy Test) [Presence], Urine DNA, Blood EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) 36-Item Short Form Survey (SF-36) Archived Sample, Saliva Stimulated Salivary Flow Test Archived Sample, Tear Schirmer Test Whole mRNA Transcriptome Sequence Analysis, Blood Rheumatoid Factor [Presence], Serum Cryoglobulin IgA+IgG+IgM+C3 Panel, Serum IgM [Mass/Vol], Serum IgG [Mass/Vol], Serum Nuclear Ab [Presence], Serum Sjogrens Syndrome-A ENA [Unit/Vol] by Immunoassay, Serum Sjogrens Syndrome-B ENA [Unit/Vol] by Immunoassay, Serum Lymphocyte T-Cell, B-Cell and NK Subsets Panel, Blood Cytokines Panel, Plasma BAFF-R Cells/100 CD19 Cells, Blood Beta-2-Microglobulin [Mass/Vol], Plasma 4-β-hydroxycholesterol/Cholesterol [Mass/Vol], Plasma Desmosine [Mass/Vol], Plasma Cathepsin S [Mass/Vol], Serum or Plasma Chemistry Panel (CHEM-14), Serum or Plasma C Reactive Protein [Mass/Vol] by HSM, Serum or Plasma Creatine Kinase [Act/Vol], Serum or Plasma Gamma Glutamyl Transferase [Act/Vol], Serum or Plasma Phosphate [Mass/Vol], Serum or Plasma Troponin I Cardiac [Mass/Vol], Serum or Plasma Complement C3 and C4 Panel [Mass/Vol], Serum or Plasma CBC W Differential Panel by Unspecified Method, Blood Coagulation Panel (PT/INR, aPTT), Platelet poor plasma Lipid Panel (CHEM), Serum or Plasma Urinalysis Macro Panel by Dipstick, Urine 12 Lead ECG (Triplicate) Biopsy, Salivary Gland Vital Signs Adverse Events Concomitant Medications Erythrocyte Sedimentation Rate, Blood
Treatment Day 42.0 TIM3	1 day	No window	IRT-Investigational Product Dispensation HCG Beta Subunit (Pregnancy Test) [Presence], Serum HCG Beta Subunit (Pregnancy Test) [Presence], Urine EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) Archived Sample, Saliva Stimulated Salivary Flow Test Archived Sample, Tear Schirmer Test Whole mRNA Transcriptome Sequence Analysis, Blood Cytokines Panel, Plasma BAFF-R Cells/100 CD19 Cells, Blood Beta-2-Microglobulin [Mass/Vol], Plasma 4-β-hydroxycholesterol/Cholesterol [Mass/Vol], Plasma Desmosine [Mass/Vol], Plasma Lymphocyte T-Cell, B-Cell and NK Subsets Panel, Blood Cathepsin S [Mass/Vol], Serum or Plasma Erythrocyte Sedimentation Rate, Blood PK Sampling, Plasma Chemistry Panel (CHEM-14), Serum or Plasma C Reactive Protein [Mass/Vol] by HSM, Serum or Plasma Creatine Kinase [Act/Vol], Serum or Plasma Gamma Glutamyl Transferase [Act/Vol], Serum or Plasma Phosphate [Mass/Vol], Serum or Plasma Troponin I Cardiac [Mass/Vol], Serum or Plasma Complement C3 and C4 Panel [Mass/Vol], Serum or Plasma CBC W Differential Panel by Unspecified Method, Blood Coagulation Panel (PT/INR, aPTT), Platelet poor plasma Lipid Panel (CHEM), Serum or Plasma Urinalysis Macro Panel by Dipstick, Urine 12 Lead ECG (Triplicate) Vital Signs Adverse Events Concomitant Medications
Treatment Day 63.0 TIM4	1 day	No window	IRT-Investigational Product Dispensation Investigational Product Return HCG Beta Subunit (Pregnancy Test) [Presence], Serum HCG Beta Subunit (Pregnancy Test) [Presence], Urine EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) 36-Item Short Form Survey (SF-36) Archived Sample, Saliva Stimulated Salivary Flow Test Archived Sample, Tear Schirmer Test Whole mRNA Transcriptome Sequence Analysis, Blood Cryoglobulin IgA+IgG+IgM+C3 Panel, Serum Rheumatoid Factor [Presence], Serum IgM [Mass/Vol], Serum IgG [Mass/Vol], Serum Nuclear Ab [Presence], Serum Sjogrens Syndrome-A ENA [Unit/Vol] by Immunoassay, Serum Sjogrens Syndrome-B ENA [Unit/Vol] by Immunoassay, Serum Cytokines Panel, Plasma BAFF-R Cells/100 CD19 Cells, Blood Beta-2-Microglobulin [Mass/Vol], Plasma 4-β-hydroxycholesterol/Cholesterol [Mass/Vol], Plasma Desmosine [Mass/Vol], Plasma Lymphocyte T-Cell, B-Cell and NK Subsets Panel, Blood Cathepsin S [Mass/Vol], Serum or Plasma Erythrocyte Sedimentation Rate, Blood PK Sampling, Plasma Chemistry Panel (CHEM-14), Serum or Plasma C Reactive Protein [Mass/Vol] by HSM, Serum or Plasma Creatine Kinase [Act/Vol], Serum or Plasma Gamma Glutamyl Transferase [Act/Vol], Serum or Plasma Phosphate [Mass/Vol], Serum or Plasma Troponin I Cardiac [Mass/Vol], Serum or Plasma Complement C3 and C4 Panel [Mass/Vol], Serum or Plasma CBC W Differential Panel by Unspecified Method, Blood Coagulation Panel (PT/INR, aPTT), Platelet poor plasma Lipid Panel (CHEM), Serum or Plasma Urinalysis Macro Panel by Dipstick, Urine 12 Lead ECG (Triplicate) Vital Signs Adverse Events Concomitant Medications
Treatment Day 84.0 TIM5	1 day	No window	HCG Beta Subunit (Pregnancy Test) [Presence], Serum HCG Beta Subunit (Pregnancy Test) [Presence], Urine EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) Chemistry Panel (CHEM-14), Serum or Plasma C Reactive Protein [Mass/Vol] by HSM, Serum or Plasma Creatine Kinase [Act/Vol], Serum or Plasma Gamma Glutamyl Transferase [Act/Vol], Serum or Plasma Phosphate [Mass/Vol], Serum or Plasma Troponin I Cardiac [Mass/Vol], Serum or Plasma Complement C3 and C4 Panel [Mass/Vol], Serum or Plasma CBC W Differential Panel by Unspecified Method, Blood Coagulation Panel (PT/INR, aPTT), Platelet poor plasma Lipid Panel (CHEM), Serum or Plasma Urinalysis Macro Panel by Dipstick, Urine 12 Lead ECG (Triplicate) Vital Signs Adverse Events Concomitant Medications
Unknown Epoch Day 14.0 TIM6	1 day	No window	Investigational Product Return HCG Beta Subunit (Pregnancy Test) [Presence], Serum HCG Beta Subunit (Pregnancy Test) [Presence], Urine EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) 36-Item Short Form Survey (SF-36) Archived Sample, Saliva Stimulated Salivary Flow Test Archived Sample, Tear Schirmer Test Whole mRNA Transcriptome Sequence Analysis, Blood Cryoglobulin IgA+IgG+IgM+C3 Panel, Serum IgM [Mass/Vol], Serum IgG [Mass/Vol], Serum Nuclear Ab [Presence], Serum Sjogrens Syndrome-A ENA [Unit/Vol] by Immunoassay, Serum Sjogrens Syndrome-B ENA [Unit/Vol] by Immunoassay, Serum Rheumatoid Factor [Presence], Serum Cytokines Panel, Plasma BAFF-R Cells/100 CD19 Cells, Blood Beta-2-Microglobulin [Mass/Vol], Plasma 4-β-hydroxycholesterol/Cholesterol [Mass/Vol], Plasma Desmosine [Mass/Vol], Plasma Lymphocyte T-Cell, B-Cell and NK Subsets Panel, Blood Cathepsin S [Mass/Vol], Serum or Plasma Erythrocyte Sedimentation Rate, Blood PK Sampling, Plasma Chemistry Panel (CHEM-14), Serum or Plasma C Reactive Protein [Mass/Vol] by HSM, Serum or Plasma Creatine Kinase [Act/Vol], Serum or Plasma Gamma Glutamyl Transferase [Act/Vol], Serum or Plasma Phosphate [Mass/Vol], Serum or Plasma Troponin I Cardiac [Mass/Vol], Serum or Plasma Complement C3 and C4 Panel [Mass/Vol], Serum or Plasma CBC W Differential Panel by Unspecified Method, Blood Coagulation Panel (PT/INR, aPTT), Platelet poor plasma Lipid Panel (CHEM), Serum or Plasma Urinalysis Macro Panel by Dipstick, Urine Biopsy, Salivary Gland 12 Lead ECG (Triplicate) Vital Signs Adverse Events Concomitant Medications
Unknown Epoch TIM7	1 day	No window	Physical Exam Body Weight Vital Signs HCG Beta Subunit (Pregnancy Test) [Presence], Serum HCG Beta Subunit (Pregnancy Test) [Presence], Urine EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) Cryoglobulin IgA+IgG+IgM+C3 Panel, Serum Rheumatoid Factor [Presence], Serum IgM [Mass/Vol], Serum IgG [Mass/Vol], Serum Nuclear Ab [Presence], Serum Sjogrens Syndrome-A ENA [Unit/Vol] by Immunoassay, Serum Sjogrens Syndrome-B ENA [Unit/Vol] by Immunoassay, Serum Chemistry Panel (CHEM-14), Serum or Plasma C Reactive Protein [Mass/Vol] by HSM, Serum or Plasma Creatine Kinase [Act/Vol], Serum or Plasma Gamma Glutamyl Transferase [Act/Vol], Serum or Plasma Phosphate [Mass/Vol], Serum or Plasma Troponin I Cardiac [Mass/Vol], Serum or Plasma Complement C3 and C4 Panel [Mass/Vol], Serum or Plasma CBC W Differential Panel by Unspecified Method, Blood Coagulation Panel (PT/INR, aPTT), Platelet poor plasma Lipid Panel (CHEM), Serum or Plasma Urinalysis Macro Panel by Dipstick, Urine 12 Lead ECG (Triplicate) Adverse Events Concomitant Medications
Unknown Epoch TIM8	1 day	No window	Physical Exam Body Weight Vital Signs HCG Beta Subunit (Pregnancy Test) [Presence], Serum HCG Beta Subunit (Pregnancy Test) [Presence], Urine EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) Cryoglobulin IgA+IgG+IgM+C3 Panel, Serum Rheumatoid Factor [Presence], Serum IgM [Mass/Vol], Serum IgG [Mass/Vol], Serum Nuclear Ab [Presence], Serum Sjogrens Syndrome-A ENA [Unit/Vol] by Immunoassay, Serum Sjogrens Syndrome-B ENA [Unit/Vol] by Immunoassay, Serum Chemistry Panel (CHEM-14), Serum or Plasma C Reactive Protein [Mass/Vol] by HSM, Serum or Plasma Creatine Kinase [Act/Vol], Serum or Plasma Gamma Glutamyl Transferase [Act/Vol], Serum or Plasma Phosphate [Mass/Vol], Serum or Plasma Troponin I Cardiac [Mass/Vol], Serum or Plasma Complement C3 and C4 Panel [Mass/Vol], Serum or Plasma CBC W Differential Panel by Unspecified Method, Blood Coagulation Panel (PT/INR, aPTT), Platelet poor plasma Lipid Panel (CHEM), Serum or Plasma Urinalysis Macro Panel by Dipstick, Urine 12 Lead ECG (Triplicate) Adverse Events Concomitant Medications