Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as LFG316 active drug
LFG316 · 6 trials · 10 indications
The primary efficacy variable for assessing the effect of LFG316 over the first 4 weeks of treatment was response rate where a patient was considered a responder if the percentage reduction from baseline in serum lactate dehydrogenase (LDH) was at least 60% at any time up to and including week 4 for that patient.
Lactate dehydrogenase (LDH) levels were measured in serum samples and the percentage change from baseline was calculated. For serum LDH, baseline was the average of all pre-dose measurements.
Response rate as defined by: 1. An improvement of 2 or more steps in vitreous haze (scale of 0 to 4), relative to baseline OR 2. An improvement of 10 or more letters in visual acuity (VA), relative to baseline OR 3. An improvement of 2 or more steps in anterior chamber cells (ACC) score (scale of 0 to 4), relative to baseline OR 4. Absence of chorioretinal lesions as determined by the investigator
Remission (complete response) was defined as any patient who had: * a vitreous haze score of 0 or 0.5 (scale of 0 to 4) in the study eye, AND * an anterior chamber cell score of 0 (scale of 0 to 4), AND * no chorioretinal lesions in the study eye, AND * was off all immune modulatory therapy (systemic, corticosteroids and topical), AND * without any worsening of uveitis during the trial.
Number or retreatments with anti-VEGF treatments will be recorded
Geographic atrophy (GA) lesion growth measured by fundus autofluorescence (FAF) from baseline to Day 505.
Number is the Estimated Difference (95% CI) in lesion size.
This primary outcome (for Part B) is reported under the Adverse Events section.
The following PK parameters were determined from the plasma concentration time profile of LFG316 using a non-compartmental method: AUClast: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration AUCinf: Area under the plasma concentration-time curve from time zero to infinity
| Arm | Type | Description |
|---|---|---|
| LFG316 then LNP023 | EXPERIMENTAL | During treatment periods 1 to 3, the regimen included LFG316 at a dosage of 20 mg/kg administered as an intravenous (i.v.) infusion biweekly. In treatment period 4, the patients were given: * LFG316 at a dosage of 20 mg/kg as an i.v. infusion every two weeks for four weeks, amounting to two infusions in total. * LNP023 at a dose of 200 mg administered orally twice daily (b.i.d.) for approximately 20 weeks, with four 50 mg capsules taken at each administration. |
| LFG316 -Intravitreal Injection | EXPERIMENTAL | - |
| Conventional Therapy | ACTIVE_COMPARATOR | - |
| LFG316 | EXPERIMENTAL | - |
| Sham | SHAM_COMPARATOR | - |
| LFG316 higher dose | EXPERIMENTAL | LFG316 10 mg/100 μL |
| LFG316 lower dose | EXPERIMENTAL | LFG316 5 mg/ 50 μL |
| LFG316 + IVIG | EXPERIMENTAL | - |
| LFG316 alone | EXPERIMENTAL | - |
| LFG316 0.15mg | EXPERIMENTAL | - |
| LFG316 0.5mg | EXPERIMENTAL | - |
| LFG316 1.5mg | EXPERIMENTAL | - |
| LFG316 5mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| LFG316 | BIOLOGICAL | LFG316 20 mg/kg was administered to all patients enrolled in the study: * Treatment Periods 1 to 3: LFG316 20 mg/kg as i.v. infusion every 2 weeks * Treatment Period 4: LFG316 20 mg/kg as i.v. infusion every 2 weeks for 4 weeks (total 2 infusions). |
| LNP023 | DRUG | Treatment Period 4: LNP023 200 mg b.i.d. for approximately 20 weeks. Four capsules (each 50 mg) were administered each time study medication was taken. |
| Conventional Therapy | DRUG | Conventional Therapy administered in accordance with its prescribing info. |
| Placebo | DRUG | Placebo will be administered as sham injections. Sham injections will involve placement of the syringe hub against the sclera, without use of a needle. |
| Sham | DRUG | Sham injection (akin to intravitreal injection but without intravitreal needle; no investigational drug given) |
| LFG316 Lower dose | DRUG | LFG316 5 mg/50 μL solution for IVT Injection |
| IVIG | DRUG | IVIG single dose |
Inclusion criteria: 1. Written informed consent obtained before any assessment were performed. 2. Male and female patients \>= 18 years old with a diagnosis of PNH prior to screening. Based on local requirements (applicable in Czech Republic) only patients between the age of 18 to 65 (inclusive) wi...
LFG316 is an investigational monoclonal antibody being studied for several conditions, including non-infectious intermediate uveitis, geographic atrophy, neovascular age-related macular degeneration (wet AMD), kidney transplantation, advanced age-related macular degeneration, and paroxysmal nocturnal hemoglobinuria. It is administered via intravitreal injection for eye-related conditions.
LFG316 is being developed by Novartis AG, which trades on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational monoclonal antibody across multiple indications.
LFG316 has completed clinical trials in Phase 1 and Phase 2. It remains an investigational drug and is not approved by the FDA. The completed trials include a Phase 1 study in advanced age-related macular degeneration and Phase 2 studies in uveitis and wet AMD.
LFG316 has completed four clinical trials. NCT01255462 was a Phase 1 study in advanced age-related macular degeneration. NCT01526889 was a Phase 2 study in non-infectious uveitis. NCT01535950 was a Phase 2 study in wet AMD. NCT02878616 was a Phase 1 study in kidney transplant patients.
LFG316 is an investigational monoclonal antibody being developed by Novartis AG for ophthalmic and other indications. It has been studied in clinical trials for conditions such as advanced age-related macular degeneration, non-infectious uveitis, wet AMD, and kidney transplantation. It is not yet approved and remains in clinical development.