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NCT06724900 (KB304 in Moderate to Severe Wrinkles of the…): BVCT ex-ante prediction vs. reported outcome

On 13 May 2025, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 24 Jul 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically maybe insignificant (no p-value reported) and commercially TBD.

Clinical Trial

NCTID
NCT06724900
Acronym
Pearl-2
Drug Name
KB304
Drug MoA
HSV1 gene therapy delivering COL3A1 and ELN transgenes
Drug Modality
gene therapy
Drug Class
First-In-Class
Therapeutic Area
Skin and Connective Tissue Diseases
Indication
Moderate to Severe Wrinkles of the Décolleté
Human Patients
376
Sponsor
Krystal Biotech
Phase
Phase 1 Phase 2

Prediction of , index 2020

Prospective Prediction
Prediction Index
2020
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in wrinkle reduction slightly inferior to KB301)
Technical Prediction
FAILURE (statistically insignificant clinical benefit in wrinkle reduction compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
72 days in advance
Readout Data Interpretation
KB304 achieved numerically higher subject-reported >=1 point GAIS improvement at three months (72.7% vs 14.3%; no p-value reported); no data reported for improvements in wrinkle severity such as JDWS
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically maybe insignificant (no p-value reported) and commercially TBD
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 1/2 Study of KB304, a Replication-Defective, Non-Integrating Vector Expressing Human Type III Collagen (COL3) and Tropoelastin for the Treatment of Wrinkles
Phase
Phase 1, Phase 2
Status
Active not recruiting
Enrollment
19
Lead sponsor
Krystal Biotech, Inc.
Conditions
Wrinkles in Decolletage; Pigmentation; Décolleté Wrinkles
Interventions
BIOLOGICAL: KB304; DRUG: 0.9% Normal Saline (NS)
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2024-11-20
Primary completion
2025-07
Completion
2025-08
Primary outcomes
  • Safety and tolerability of KB304 versus placebo administered by intradermal injection (Up to 4 months)

NCT06724900 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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