Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-6628 · 1 trial · 2 indications
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Number of participants with abnormal change in physical examinations in areas like cardiovascular, respiratory, gastrointestinal, and neurological systems will be assessed.
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
12-lead resting ECGs will be recorded. Parameters include heart rate, PR interval, QT interval, QRS duration, and QT interval corrected using Fridericia's formula (QTcF).
Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
BCVA measured by Early Treatment Diabetic Retinopathy Study (ETDRS) (normal luminance and low luminance visual acuity)
Changes in Slit lamp biomicroscopy assessed by the physician will be assessed.
Measured by using Goldmann applanation tonometry (GAT) or hand-held tonometer
Changes in Lens examination assessed by the physician will be assessed.
Changes in Ophthalmoscopy assessed by the physician will be assessed.
Fundus autofluorescence (FAF) imaging assessed by Investigator
Measured by color fundus photography (CFP) imaging assessed by Investigator
Spectral domain optical coherence tomography (SD-OCT)
Fluorescein angiography (FA) assessed by Investigator
Choroidal Neovascularization (CNV) assessed by Investigator.
Post-treatment Administration Assessment (study eye only)
Cmax of ABBV-6628
Tmax of ABBV-6628
AUC0-Tlast of ABBV-6628
Ctrough of ABBV-6628
| Arm | Type | Description |
|---|---|---|
| ABBV-6628: Stage 1-Cohort 1 | EXPERIMENTAL | Participants will receive a single dose of ABBV-6628 in Cohort 1 on day 1. |
| ABBV-6628: Stage 1 -Cohort 2 | EXPERIMENTAL | Participants will receive a single dose of ABBV-6628 in Cohort 2 on day 1. |
| ABBV-6628: Stage 1 -Cohort 3 | EXPERIMENTAL | Participants will receive a single dose of ABBV-6628 in Cohort 3 on day 1. |
| ABBV-6628: Stage 1 -Cohort 4 | EXPERIMENTAL | Participants will receive ABBV-6628 in Cohort 4 on day 1 and month 2. |
| ABBV-6628: Stage 2 | EXPERIMENTAL | Participants will receive ABBV-6628 for approximately 22 months followed by 3 months of follow-up. |
| SYFOVRE: Stage 2 | EXPERIMENTAL | Participants will receive SYFOVRE for approximately 22 months followed by 3 months of follow-up. |
| Name | Type | Description |
|---|---|---|
| ABBV-6628 | DRUG | Intravitreal injection |
| SYFOVRE | DRUG | Intravitreal injection |
Inclusion Criteria: Stage 1 and Stage 2 -Diagnosed with Geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in the study eye. Stage 1 * Foveal or non-foveal GA with total GA lesion area ≥ 0.5 DA (1.25 mm2) in the study eye, as assessed by the investigator at Screening and...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE3 | Pozelimab, Cemdisiran |
| Annexon, Inc. | ANNX | 1 | PHASE3 | Vonaprument |
| Belite Bio, Inc. ADR | BLTE | 1 | PHASE3 | Tinlarebant |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-81201887 |
| AbbVie, Inc. | ABBV | 1 | PHASE1 | ABBV-6628, SYFOVRE |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR446597, Sham Comparator |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU410 |
| Apellis Pharmaceuticals, Inc. | APLS | 1 | - | Pegcetacoplan |
ABBV-6628 is an investigational small molecule being developed for the treatment of geographic atrophy, a form of age-related macular degeneration. It is administered via intravitreal injection and is currently in Phase 1 clinical development.
ABBV-6628 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug is currently in Phase 1 clinical trials for geographic atrophy.
ABBV-6628 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study is currently recruiting participants to evaluate the drug's safety and how it moves through the body.
ABBV-6628 is being studied in a Phase 1 clinical trial with the identifier NCT07160179. This randomized, double-blind, controlled study is assessing adverse events and the pharmacokinetics of intravitreal ABBV-6628 in adult participants with geographic atrophy secondary to age-related macular degeneration. The trial is recruiting up to 66 participants in the United States.
ABBV-6628 is administered via intravitreal injection, meaning it is injected directly into the vitreous humor of the eye. This route of administration is commonly used for ophthalmic therapies targeting conditions like geographic atrophy.