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Caffeine

Phase 1

Psoriasis | Small molecule | Immunology |AbbVie Inc.|Last Updated: Sep 25, 2017

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment21
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02772601This Study Tests the Effect of Risankizumab on the Metabolism in the Liver of Five Additional Drugs to Study Possible Drug Interactions in Patients With Psoriasis With or Without Psoriatic ArthritisPHASE1 COMPLETED 21 — — Sep 15, 2016Sep 22, 2017Sep 25, 20171 Germany
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Study Endpoints
Primary Endpoints
AUC0 - tz (area under the concentration-time curve) of caffeine with risankizumab in plasma over time interval from 0 to last quantifiable data point
Day 98-101
AUC0 - tz (area under the concentration-time curve) of caffeine without risankizumab in plasma over time interval from 0 to last quantifiable data point
Day 1-3
AUC0 - tz (area under the concentration-time curve) of warfarin with risankizumab in plasma over time interval from 0 to last quantifiable data point
Day 98 - 105
AUC0 - tz (area under the concentration-time curve) of warfarin without risankizumab in plasma over time interval from 0 to last quantifiable data point
Day 1-8
AUC0 - tz (area under the concentration-time curve) of omeprazole with risankizumab in plasma over time interval from 0 to last quantifiable data point
Day 98 - 100
AUC0 - tz (area under the concentration-time curve) of omeprazole without risankizumab in plasma over time interval from 0 to last quantifiable data point
Day 1-2
AUC0 - tz (area under the concentration-time curve) of metoprolol with risankizumab in plasma over time interval from 0 to last quantifiable data point
Day 98 -100
AUC0 - tz (area under the concentration-time curve) of metoprolol without risankizumab in plasma over time interval from 0 to last quantifiable data point
Day 1-3
AUC0 - tz (area under the concentration-time curve) of midazolam with risankizumab in plasma over time interval from 0 to last quantifiable data point
Day 98 - 99
AUC0 - tz (area under the concentration-time curve) of midazolam without risankizumab in plasma over time interval from 0 to last quantifiable data point
Day 1-2
Cmax (maximum measured concentration) of the analyte omeprazole without risankizumab in plasma
Day 1
Cmax (maximum measured concentration) of the analyte metoprolol with risankizumab in plasma
Day 98
Cmax (maximum measured concentration) of the analyte metoprolol without risankizumab in plasma
Day 1
Cmax (maximum measured concentration) of the analyte midazolam with risankizumab in plasma
Day 98
Cmax (maximum measured concentration) of the analyte midazolam without risankizumab in plasma
Day 1
Cmax (maximum measured concentration) of the analyte caffeine with risankizumab in plasma
Day 98
Cmax (maximum measured concentration) of the analyte caffeine without risankizumab in plasma
Day 1
Cmax (maximum measured concentration) of the analyte warfarin with risankizumab in plasma
Day 98
Cmax (maximum measured concentration) of the analyte warfarin without risankizumab in plasma
Day 1
Cmax (maximum measured concentration) of the analyte omeprazole with risankizumab in plasma
Day 98
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
All patientsEXPERIMENTAL -
Interventions
NameTypeDescription
CaffeineDRUG -
WarfarinDRUG -
OmeprazoleDRUG -
MetoprololDRUG -
MidazolamDRUG -
RisankizumabDRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion criteria: * Signed and dated written informed consent in accordance with GCP (Good Clinical Practice) and local legislation prior to admission to the trial and prior to any trial related procedure. * Age 18 years to 75 years at screening * Body mass index of 18.5 to 40.0 kg/m2 and within ...

Countries:Germany
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Competitive Landscape -Psoriasis 54 trials
CompanyTickerTrialsLead PhaseDrugs
Johnson & JohnsonJNJ10PHASE3JNJ-77242113, Deucravacitinib, Ustekinumab, Guselkumab, Etanercept
Bristol-Myers Squibb CompanyBMY14PHASE3BMS-986165, Deucravacitinib, Ustekinumab, Any biologic treatment for psoriasis, Systemic psoriasis medications
AbbVie, Inc.ABBV5PHASE3Risankizumab
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK3PHASE3TAK-279, Zasocitinib
Alumis Inc.ALMS2PHASE3Open-Label Envudeucitinib, Blinded Envudeucitinib, envudeucitinib
Eli Lilly and CompanyLLY1PHASE3Ixekizumab, Tirzepatide
Amgen Inc.AMGN2PHASE3Apremilast
Oruka Therapeutics, Inc.ORKA4PHASE2ORKA-001 Induction Dose, ORKA-002, ORKA-001
Can-Fite BioPharmaCANF1PHASE3piclidenoson
Organon & Co.OGN1PHASE3tapinarof , 1%
Vanda Pharmaceuticals Inc.VNDA1PHASE3Ponesimod
Zai Lab Ltd. Sponsored ADRZLAB1PHASE2ZL-1102 1% w/w for 16 weeks, ZL-1102 3% w/w for 16 weeks
Novartis AG Sponsored ADRNVS3 — Secukinumab
Bausch Health Companies Inc.BHC2 — Brodalumab, Matched cohort, Comparator Drug
Sage BionetworksSAGE1 — Undisclosed
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