Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AAVCAGsCD59
JNJ-81201887 · 3 trials · 3 indications
Number of participants with ocular and systemic TEAEs will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as any adverse event occurring at or after the administration of study intervention.
Number of participants with abnormal findings in clinical laboratory Assessments (including hematology and clinical chemistry) will be reported.
Number of participants with abnormal findings in retinal imaging (Fundus Autofluorescence, Spectral Domain Optical Coherence Tomography) and eye examinations will be reported.
BCVA will be assessed using the ETDRS chart at a starting distance of 4 meters. The ETDRS score ranges from 0 to 100 letters, where an increase in the number of letters read correctly means that visual acuity has improved and vice-versa.
Change from baseline in GA lesion area in the study at month 18 eye will be measured via retinal imaging using fundus auto fluorescence (FAF).
Rate of Change in untransformed GA lesion area in the study eye will be measured via retinal imaging using FAF. A piecewise linear mixed effects (PLME) model will be used for the primary efficacy analysis for rate of change in GA area (GAA) in the study eye.
Measure intraocular inflammation, ocular changes and systemic side effects following a single intraocular injection of AAVCAGsCD59
| Arm | Type | Description |
|---|---|---|
| Arm A: JNJ-81201887 Low Dose | EXPERIMENTAL | Study participants who were enrolled and received treatment with low dose JNJ-81201887 in parent clinical studies (81201887MDG2001 \[NCT05811351\]; 81201887MDG1003) will enter this long-term extension (LTE) study. No study intervention will be administered as part of this study. |
| Arm B: JNJ-81201887 High dose | EXPERIMENTAL | Study participants who were enrolled and received treatment with high dose JNJ-81201887 in parent clinical studies (81201887MDG2001 \[NCT05811351\]; 81201887MDG1003) will enter this LTE study. No study intervention will be administered as part of this study. |
| Arm C: Sham Procedure | SHAM_COMPARATOR | Participants randomized to the sham arm in parent study 81201887MDG2001 (NCT05811351) will enter this LTE study. No intervention will be administered as part of this study. |
| Low Dose | EXPERIMENTAL | AAVCAGsCD59 |
| Mid Dose | EXPERIMENTAL | AAVCAGsCD59 |
| High Dose | EXPERIMENTAL | AAVCAGsCD59 |
| Name | Type | Description |
|---|---|---|
| JNJ-81201887 | DRUG | No study intervention will be administered as part of this LTE study. |
| Sham Procedure | OTHER | No study intervention will be administered as part of this LTE study. |
| Prednisone | DRUG | Prednisone will be administered as oral capsule. |
| Placebo | OTHER | Prednisone matching placebo will be administered as oral capsule. |
| Triamcinolone | DRUG | Triamcinolone (corticosteroid injection) periocular injection will be administered as per local practice. |
| AAVCAGsCD59 | BIOLOGICAL | AAVCAGsCD59 is administered as a single intravitreal injection in an office setting |
Inclusion Criteria: * Participants who were enrolled and received treatment with JNJ-81201887 or sham in a parent clinical study (81201887MDG2001, 81201887MDG1003) * Females (women of childbearing potential), male participants, and partners of male participants will not be required to use contracep...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE3 | Pozelimab, Cemdisiran |
| Belite Bio, Inc. ADR | BLTE | 1 | PHASE3 | Tinlarebant |
| Annexon, Inc. | ANNX | 2 | PHASE3 | Vonaprument (ANX007) |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-81201887 |
| AbbVie, Inc. | ABBV | 1 | PHASE1 | ABBV-6628 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR446597 |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU410 |
| Genentech, Inc. | RHHBY | 1 | PHASE2 | OpRegen |
| Apellis Pharmaceuticals, Inc. | APLS | 1 | - | Pegcetacoplan |
JNJ-81201887 is an investigational small molecule being developed for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). It is administered via intravitreal injection and is currently in Phase 2 clinical development. Geographic atrophy is a progressive eye disease that leads to vision loss.
JNJ-81201887 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is currently in Phase 2 clinical trials for geographic atrophy secondary to age-related macular degeneration.
JNJ-81201887 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. There are two Phase 2 trials: one completed study and one actively recruiting long-term extension study.
JNJ-81201887 has two Phase 2 trials. NCT05811351 is a completed sham-controlled study with 305 participants evaluating the drug for geographic atrophy. NCT06635148 is a recruiting long-term extension study with 274 participants. Both involve patients aged 60 years and older.
Yes, JNJ-81201887 is also known as AAVCAGsCD59. This alternative name appears in the clinical trial titles for both the completed study NCT05811351 and the recruiting extension study NCT06635148, which evaluate the drug for geographic atrophy secondary to age-related macular degeneration.