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RN

Phase 1

Age-Related Maculopathy | Monoclonal antibody | Ophthalmology |Pfizer, Inc.|Last Updated: May 12, 2022

Success Probability

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment81

FDA Designations

No designations recorded

Clinical trial landscape

RN · 2 trials · 5 indications

Phase 1 2
NCT01003691Safety And Tolerability Study Of RN6G In Subjects With Advanced Dry, Age-Related Macular Degeneration Including Geographic AtrophyAge-Related Maculopathy
COMPLETED24 Analytics
NCT00877032Safety And Tolerability Study Of RN6G In Patients With Dry, Age-Related Macular DegenerationAge-Related Maculopathy
COMPLETED57 Analytics
PHASE1COMPLETED
Safety And Tolerability Study Of RN6G In Subjects With Advanced Dry, Age-Related Macular Degeneration Including Geographic Atrophy
Age-Related MaculopathyUnlock trial analytics
PHASE1COMPLETED
Safety And Tolerability Study Of RN6G In Patients With Dry, Age-Related Macular Degeneration
Age-Related MaculopathyUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Toxicity or Intolerable Dose Criteria
Baseline up to Day 304/End of Treatment (ET)

The dose was considered intolerable if a participant developed either ocular toxicity or other toxicity as per Common Terminology Criteria for Adverse Events (CTCAE) or based on the investigator's discretion. Ocular toxicity included: Grade \>= 3 (retinopathy, retinal detachment, cataract formation, optic disk edema, keratitis, vitreous hemorrhage and uveitis) and acute vision loss of greater than 3 lines of vision up to and including 140 days after the first dose. Other toxicity included serious adverse event (SAE), Grade \>= 3 (increased liver transaminases, encephalopathy/leukoencephalopathy, diarrhea, enteritis or nausea, prolongation of QT interval \[Fridericia's correction\]), Grade \>=2 (central nervous system hemorrhage, decreased total leukocyte count, increased serum creatinine) and thrombocytopenia \<100\*10 9 /liter.

Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity
Baseline up to Day 304/ET

AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. AE was assessed according to severity; Grade 1 (mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated), Grade 2 (moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living \[ADL\]), Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL), Grade 4 (life-threatening consequences; urgent intervention indicated) and Grade 5 (death related to AE).

Number of Participants With Treatment Emergent Adverse Events (TEAEs): All Causalities and TEAEs Categorized by Causal Relationship to Study Drug
Baseline up to Day 304/ET

All causalities AE was any untoward medical occurrence in participant who received study drug without regard to causal relationship. Drug-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. All causalities and drug-related AEs reported wherein drug-related AEs were reported as ocular and non-ocular AEs. Ocular AEs were events which were localized in the ocular region and non-ocular AEs were systemic events which were not localized but occurred throughout the systemic circulation.

Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity
Baseline up to Day 304/ET

AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. Ocular AE were events which were localized in the ocular region and was assessed according to severity; Grade 1 (mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated), Grade 2 (moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL), Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL), Grade 4 (life-threatening consequences; urgent intervention indicated) and Grade 5 (death related to AE).

Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug
Baseline up to Day 304/ET

AE was any untoward medical occurrence in participant who received study drug without regard to causal relationship and drug-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. Ocular AEs were events which were localized in the ocular region. Ocular AEs reported as related and non-related to study drug.

Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity
Baseline up to Day 304/ET

AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. Systemic AE were events which were not localized but occurred throughout the systemic circulation and was assessed according to severity; Grade 1 (mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated), Grade 2 (moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL), Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL), Grade 4 (life-threatening consequences; urgent intervention indicated) and Grade 5 (death related to AE).

Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Study Drug
Baseline up to Day 304/ET

AE was any untoward medical occurrence in participant who received study drug without regard to causal relationship and drug-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to Day 304/ET that were absent before treatment or that worsened relative to pretreatment state. Systemic TEAEs were events which were not localized but occurred throughout the systemic circulation and reported as related and non-related to study drug.

Number of Participants With Positive Anti-Drug-Antibodies (ADA) and Neutralizing Antibodies (Nab)
Baseline up to Day 304/ET

The immunogenicity of RN6G (PF-04382923) in terms of producing an antidrug antibody (ADA) and neutralizing antibody response were assessed. Neutralizing antibody response were to be assess in participants with positive ADA samples.

Incidence and Severity of Ocular Adverse Events (AEs)
Baseline up to Day 168

AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. Ocular AE was identified by spontaneous report or ocular examination: early treatment diabetic retinopathy study (ETDRS) best-corrected visual acuity (BCVA); low-luminance BCVA; pupillary light response, extra-ocular muscle movements, external examination of the eyelids and eyelashes, slit-lamp biomicroscopic examination (SLE) of all components of the anterior and posterior segments, intra-ocular pressure (IOP), and dilated ocular fundus examination of the vitreous and retina. AE was assessed according to severity; mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) and severe (interfered significantly with participant's usual function). Total number of participants with ocular (related to eye) AEs and severity was reported.

Incidence and Severity of Systemic Adverse Events (AEs)
Baseline up to Day 168

AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. Systemic AEs was identified by spontaneous report or physical and neurological examinations changes in vital signs, clinical laboratory abnormalities, 12-lead electrocardiograms (ECG), brain magnetic resonance imaging (MRI). AE was assessed according to severity; mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) and severe (interfered significantly with participant's usual function). Total number of participants with systemic (all AEs including eye-related) AEs and severity was reported.

Secondary Endpoints

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of RN6G (PF-04382923)
Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 168, 336 hours on Day 1 and 1, 2, 4, 24, 336, 672 hours on Day 140
Maximum Observed Plasma Concentration (Cmax) of RN6G (PF-04382923)
Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 168, 336 hours on Day 1 and 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140
Minimum Observed Plasma Trough Concentration (Cmin) of RN6G (PF-04382923)
Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24, 336, 672, 1992, 3936 hours on Day 140
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -

Interventions

NameTypeDescription
RN6GBIOLOGICALIntravenous, multiple dose, dose ranging from 5 mg/kg up to a maximum of 15 mg/kg
PlaceboBIOLOGICALIntravenous, multiple dose with experimental dose
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Eligibility Criteria

Age Range60 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: * Be of non-child bearing potential * Diagnosis of dry AMD including uni- or multi-focal geographic atrophy without foveal involvement * BCVA of 20/50 or better in the study eye Exclusion Criteria: * Evidence of ocular disease other than advanced AMD or GA in the study eye * H...

Countries:United States
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Frequently asked questions about RN

What is RN used for?

RN is an investigational monoclonal antibody being developed for age-related maculopathy, specifically dry age-related macular degeneration. It is being studied in patients with dry AMD, including those with advanced disease and geographic atrophy. The drug is currently in Phase 1 clinical development.

Who makes RN?

RN is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is an investigational monoclonal antibody in Phase 1 clinical trials for age-related maculopathy.

What phase is RN in?

RN is in Phase 1 clinical development. Two Phase 1 trials have been completed, both focusing on safety and tolerability in patients with dry age-related macular degeneration. The drug is not yet approved and remains investigational.

What clinical trials is RN in?

RN has been studied in two completed Phase 1 trials: NCT00877032, which enrolled 57 patients with dry AMD, and NCT01003691, which enrolled 24 subjects with advanced dry AMD including geographic atrophy. Both trials were conducted in the United States.

Is RN the same as RN6G?

Yes, RN is also known as RN6G. Clinical trial records for NCT00877032 and NCT01003691 refer to the drug as RN6G, studying it in patients with dry age-related macular degeneration. Both names refer to the same investigational monoclonal antibody.