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NCT06362759 (Pacibekitug in Chronic Kidney Disease and Elevated High-Sensitivity…): BVCT ex-ante prediction vs. reported outcome

On 9 Nov 2024, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 20 May 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially TBD (UACR/UPCR/eGFR data pending).

Clinical Trial

NCTID
NCT06362759
Acronym
TRANQUILITY
Drug Name
Pacibekitug (TOUR006)
Drug MoA
anti-IL6 inhibitor
Drug Modality
monoclonal antibody
Drug Class
First-In-Class
Therapeutic Area
Urogenital Diseases
Indication
Chronic Kidney Disease and Elevated High-Sensitivity C-Reactive Protein (Hs-CRP)
Human Patients
143
Sponsor
Tourmaline Bio
Phase
Phase 2

Prediction of , index 1838

Prospective Prediction
Prediction Index
1838
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in UACR/UPCR/eGFR inferior to finerenone)
Technical Prediction
SUCCESS (statistically significant yet moderate clinical benefit in hs-CRP reduction against placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
192 days in advance
Readout Data Interpretation
pacibekitug achieved more than 70% placebo-adjusted hs-CRP >=50% reduction at day 90 (p<0.0001)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially TBD (UACR/UPCR/eGFR data pending)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Quarterly and Monthly TOUR006 in Participants With Chronic Kidney Disease and Elevated High-Sensitivity C-Reactive Protein
Phase
Phase 2
Status
Completed
Enrollment
143
Lead sponsor
Tourmaline Bio, Inc., a Novartis Company
Conditions
Chronic Kidney Diseases; Chronic Kidney Insufficiency; Chronic Renal Diseases; Chronic Renal Insufficiency; Kidney Insufficiency, Chronic; C-Reactive Protein; High Sensitivity C-Reactive Protein; Hs-CRP; hsCRP
Interventions
DRUG: TOUR006 - 50 MG; DRUG: TOUR006 - 25 MG; DRUG: TOUR006 - 15 MG; OTHER: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2024-05-15
Primary completion
2025-03-06
Completion
2025-12-04
Results first posted
2026-08-11
Primary outcomes
  • Time-Averaged Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Through Day 90 (Baseline through 90 days. Baseline is defined as the average of the last two available visits prior to study treatment administration.)

NCT06362759 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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