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subcutanious administration

Phase 1

Arthritis, Rheumatoid | Small molecule | Musculoskeletal |GSK plc|Last Updated: Nov 16, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment28
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01101555Repeat Dose Subcutaneous Rhumatoid Arthritis Efficacy StudyPHASE1 COMPLETED 28 — — May 12, 2010Nov 29, 2012Nov 16, 20221 Russia
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Study Endpoints
Primary Endpoints
Adverse Events (AEs)
1 month
Change from baseline and number of subjects outside the normal range for blood pressure, heart rate, temperature, electrocardiography parameters (12-lead)
1 month
Change from baseline in clinical chemistry and haematology parameters
1 month
Epstein-Barr Virus viral load
1 month
Individual absolute and percentage circulating peripheral T lymphocytes and CD4+ and CD8+ subset counts
1 month
Saturation of CD3 antigen on peripheral blood T cells
1 month
Secondary Endpoints
Individual serum concentrations of otelixizumab and data permitting summary PK parameters
1 month
Serum levels of anti-otelixizumab binding antibodies. Where binding antibodies are detected, proportion which are anti-otelixizumab neutralising antibodies.
1 month
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
COHORT 1: CUMULATIVE DOSE 1.5MG, ADMINISTERED SUBCUTANEOUSLYEXPERIMENTALDuration of treatment 3 days, dose 0.3, 0.5, 0.7, four patients in cohort, one of which is on placebo, escalation increment N/A
COHORT 2: CUMULATIVE DOSE 3.5MG, ADMINISTERED SUBCUTANEOUSLYEXPERIMENTALDuration of treatment 5 days, dose 0.3, 0.5, 0.7, 1.0, 1.0 four patients in cohort, one of which is on placebo, escalation increment 2.3 fold.
COHORT 3: CUMULATIVE DOSE 6.0MG, ADMINISTERED SUBCUTANEOUSLYEXPERIMENTALDuration of treatment 7 days, dose 0.3, 0.7, 5 x 1.0 four patients in cohort, one of which is on placebo, escalation increment 1.7 fold.
COHORT 4: CUMULATIVE DOSE 8.0MG, ADMINISTERED SUBCUTANEOUSLYEXPERIMENTALDuration of treatment 5 days, dose 0.3, 0.7, 1.0, 2 x 3.0 four patients in cohort, one of which is on placebo, escalation increment 1.33 fold.
COHORT 5: CUMULATIVE DOSE 10MG, ADMINISTERED SUBCUTANEOUSLYEXPERIMENTALDuration of treatment 10 days, dose 10 x 1.0 four patients in cohort, one of which is on placebo, escalation increment 1.25 fold.
COHORT 6: CUMULATIVE DOSE 15MG, ADMINISTERED SUBCUTANEOUSLYEXPERIMENTALDuration of treatment 15 days, dose 15 x 1.0 six patients in cohort, one of which is on placebo, escalation increment 1.5 fold.
COHORT 7: CUMULATIVE DOSE 15MG, ADMINISTERED SUBCUTANEOUSLYEXPERIMENTALDuration of treatment 5 days, dose 5 x 3.0 six patients in cohort, one of which is on placebo, escalation increment N/A
Interventions
NameTypeDescription
subcutanious administrationDRUGdrug will be administered subcutaneously in varying amounts over a verying time period according to details stated in the 'arms' section
PlaceboOTHERPlacebo will be given to one member of each cohort.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. Male or female subjects between 18 and 75 years of age inclusive. 2. A female subject is eligible to participate if she is of: 1. Non-childbearing potential defined as pre...

Countries:Russia
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