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NCT06395948 (APG777 in moderate-to-severe Atopic Dermatitis): BVCT ex-ante prediction vs. reported outcome

On 23 Jan 2025, BioinvestGPT's BVCT predicted technical success and commercial partial success for this trial. The 7 Jul 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient.

Clinical Trial

NCTID
NCT06395948
Acronym
APEX
Drug Name
APG777
Drug MoA
YTE-and-LALA-modified anti-IL13 inhibitor
Drug Modality
monoclonal antibody
Drug Class
Best-In-Class
Therapeutic Area
Skin and Connective Tissue Diseases
Indication
moderate-to-severe Atopic Dermatitis
Human Patients
431
Sponsor
Apogee Therapeutics
Phase
Phase 2

Prediction of , index 1882

Prospective Prediction
Prediction Index
1882
Prediction Date
Commercial Prediction
partial SUCCESS (commercially maybe sufficient yet moderate clinical benefit in EASI75 at least numerically superior to lebrikizumab yet still inferior to upadacitinib)
Technical Prediction
SUCCESS (statistically significant clinical benefit in EASI75 compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
165 days in advance
Readout Data Interpretation
APG777 achieved 42.3% placebo-adjusted EASI75 at week 16 (p < 0.001); numerically superior to lebrikizumab's 38% placebo-adjusted EASI75 at week 16 averaged from two phase 3 trials (see 10.1056/NEJMoa2206714); and inferior to upadacitinib’s nearly 60% placebo-adjusted EASI75 at week 24 (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Two-part, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of APG777 in Patients With Moderate-to-severe Atopic Dermatitis
Phase
Phase 2
Status
Active not recruiting
Enrollment
470
Lead sponsor
Apogee Therapeutics, Inc.
Conditions
Atopic Dermatitis
Interventions
DRUG: APG777; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2024-04-29
Primary completion
2026-11
Completion
2028-06
Primary outcomes
  • Part A: Percent Change From Baseline in Eczema Area and Severity Index (EASI) (Baseline and at Week 16)
  • Part B: Proportion of participants who achieve EASI 75 at Week 16 (At Week 16)

NCT06395948 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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