BioinvestGPT

BioinvestGPT ApS · Research use only

NCT05387083 (TP-05 in Lyme Disease): BVCT ex-ante prediction vs. reported outcome

On 15 Jan 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 22 Feb 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient (theoretical efficacy upper limit).

Clinical Trial

NCTID
NCT05387083
Acronym
CARPO
Drug Name
TP-05
Drug MoA
anti-GABACI inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Infections
Indication
Lyme Disease
Human Patients
30
Sponsor
Tarsus Pharmaceuticals
Phase
Phase 2

Prediction of , index 1412

Prospective Prediction
Prediction Index
1412
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
38 days in advance
Readout Data Interpretation
primary endpoint and key secondary endpoint met 97% vs 5% tick mortality p<0.0001.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient (theoretical efficacy upper limit)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 2a, Randomized, Double-Blind, Placebo Controlled, Single-Center, Human Tick Kill Proof-of-Concept Study Evaluating the Safety, Tolerability, and Whole Blood Concentration of TP-05 (lotilaner) in Healthy Volunteers
Phase
Phase 2
Status
Completed
Enrollment
30
Lead sponsor
Tarsus Pharmaceuticals, Inc.
Conditions
Healthy Volunteer
Interventions
DRUG: Low Dose TP-05; DRUG: High Dose TP-05; DRUG: Placebo Comparator
Design
Randomized · Parallel · Quadruple
Primary purpose
Other
Start
2022-12-12
Primary completion
2024-06-26
Completion
2024-06-26
Primary outcomes
  • The Incidence of treatment emergent adverse events from baseline (Day -1 through Day 301)
  • Clinically significant changes from Baseline chemistry laboratory tests (Day -1 through Day 301)
  • Clinically significant changes from Baseline hematology laboratory tests (Day -1 through Day 301)
  • Clinically significant changes from Baseline vital signs (Day -1 through Day 301)
  • Clinically significant changes from Baseline electrocardiograms (ECGs) (Day -1 through Day 301)

NCT05387083 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials