Not provided
Not provided
Not provided
Not provided
Not provided
This study terminated on April 8, 2015 due to a corporate decision and not related to the safety or efficacy of the protocol.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
PF-06342674 (RN168), being developed for the treatment of multiple sclerosis (MS), is an antibody that binds to and inhibits the human interleukin-7 receptor, a component potentially involved in MS. PF-06342674 (RN168) is expected to play a role in slowing down the progression of the disease.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental |
| |
| PF-06342674 1.5 mg/kg | Experimental |
| |
| PF-06342674 6.0 mg/kg (q2 Weeks) | Experimental |
| |
| PF-06342674 6.0 mg/kg (q1 Week) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06342674 0.25 mg/kg | Biological | Bi-Weekly Subcutaneous Injections X 6 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs | An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to Day 127/Early Termination that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. | Baseline through Day 127/Early Termination |
| Number of Treatment-Emergent AEs and SAEs by Severity | AE severity was graded as mild, moderate, or severe. Mild AEs do not interfere with the participant's usual function. Moderate AEs interfere to some extent with the participant's usual function. Severe AEs interfere significantly with the participant's usual function. | Baseline through Day 127/Early Termination |
| Number of Participants With Clinical Laboratory Abnormalities | Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, liver function, renal function, electrolytes, hormones, clinical chemistry, and urinalysis (dipstick and microscopy). Abnormal laboratory findings included: lymphocytes (absolute) less than (<)0.8 x lower limit of normal (LLN); urine blood/hemoglobin (qualitative) more than or equal to (>=)1; urine nitrite >=1; urine leukocyte esterase >=1; urine red blood cell (RBC) >=20/high-power field (HPF). | Baseline through Day 127/Early Termination |
| Number of Participants With Clinically Significant Changes in Vital Signs | Categorical summarization criteria in vital signs included: supine systolic blood pressure (SBP) of <90 millimeters of mercury (mm Hg) or change in supine SBP of >=30 mm Hg; supine diastolic blood pressure (DBP) of <50 mm Hg or change in supine DBP of >=20 mm Hg; supine pulse rate of <40 or more than (>)120 beats per minute (bpm). |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of PF-06342674 | Baseline through Day 127/Early Termination |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albany Advanced Imaging | Albany | New York | 12205 | United States | ||
| Fallon Wellness Pharmacy |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Participants were screened within 45 days prior to the first administration of the study drug to confirm that they met the participant inclusion criteria for the study.
This study was a Phase 1b, randomized, multi-center, double-blind, sponsor-open, placebo controlled study to evaluate multiple ascending doses of PF-06342674 in participants with Multiple Sclerosis (MS). Up to 60 participants were planned to be enrolled. However, only 4 participants were randomized due to the early termination of the study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo subcutaneously (SC) every other week during an 85-day treatment period. |
| FG001 | PF-06342674 0.25 mg/kg | Participants received PF-06342674 0.25 milligram (mg)/kilogram (kg) SC every other week during an 85-day treatment period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Biological |
Bi-Weekly Subcutaneous Injections X 6 |
|
| PF-06342674 1.5 mg/kg | Biological | Bi-Weekly Subcutaneous Injections X 6 |
|
| PF-06342674 6.0 mg/kg | Biological | Bi-Weekly Subcutaneous Injections X 6 |
|
| Baseline through Day 127/Early Termination |
| Number of Participants With Abnormal Electrocardiogram (ECG) | Criteria for potential clinical concern in ECG parameters: The maximum of the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formula (QTcF) >=450 milliseconds (msec), maximum QTcF interval change from baseline in range of 30 to <60 msec and >=60 msec. | Baseline through Day 127/Early Termination |
| Number of Participants With Confirmed Positive Anti-Drug Antibodies (ADAs) | Assays for the determination of a positive immune response was performed. An antibody immune response was defined as a confirmed post-treatment positive enzyme-linked immunosorbent assay (ELISA) result in combination with a negative baseline sample ELISA result. ADA positive was defined as ADA titer (ie, the reciprocal of the highest dilution that gives a value equivalent to the cut point of the assay) >=4.32. | Baseline, and Days 15, 29, 57, 85 and Day 127/Early Termination |
| Latham |
| New York |
| 12110 |
| United States |
| Northeast Eye Center | Latham | New York | 12110 | United States |
| The MS Center of Northeastern New York | Latham | New York | 12110 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Retina Vitreous Center | Edmond | Oklahoma | 73013 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Radiology Associates (X-ray facility only) | Oklahoma City | Oklahoma | 73112 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo SC every other week during an 85-day treatment period. |
| BG001 | PF-06342674 0.25 mg/kg | Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Gender | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs | An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to Day 127/Early Termination that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. | The safety analysis population consists of all participants who received at least 1 dose of study drug. | Posted | Number | participants | Baseline through Day 127/Early Termination |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Treatment-Emergent AEs and SAEs by Severity | AE severity was graded as mild, moderate, or severe. Mild AEs do not interfere with the participant's usual function. Moderate AEs interfere to some extent with the participant's usual function. Severe AEs interfere significantly with the participant's usual function. | The safety analysis population consists of all participants who received at least 1 dose of study drug. | Posted | Number | adverse events | Baseline through Day 127/Early Termination |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinical Laboratory Abnormalities | Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, liver function, renal function, electrolytes, hormones, clinical chemistry, and urinalysis (dipstick and microscopy). Abnormal laboratory findings included: lymphocytes (absolute) less than (<)0.8 x lower limit of normal (LLN); urine blood/hemoglobin (qualitative) more than or equal to (>=)1; urine nitrite >=1; urine leukocyte esterase >=1; urine red blood cell (RBC) >=20/high-power field (HPF). | The safety analysis population consists of all participants who received at least 1 dose of study drug. | Posted | Number | participants | Baseline through Day 127/Early Termination |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Significant Changes in Vital Signs | Categorical summarization criteria in vital signs included: supine systolic blood pressure (SBP) of <90 millimeters of mercury (mm Hg) or change in supine SBP of >=30 mm Hg; supine diastolic blood pressure (DBP) of <50 mm Hg or change in supine DBP of >=20 mm Hg; supine pulse rate of <40 or more than (>)120 beats per minute (bpm). | The safety analysis population consists of all participants who received at least 1 dose of study drug. | Posted | Number | participants | Baseline through Day 127/Early Termination |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Abnormal Electrocardiogram (ECG) | Criteria for potential clinical concern in ECG parameters: The maximum of the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formula (QTcF) >=450 milliseconds (msec), maximum QTcF interval change from baseline in range of 30 to <60 msec and >=60 msec. | The safety analysis population consists of all participants who received at least 1 dose of study drug. The QTcF interval of the participant in the placebo arm was in this range of 450 to <480 msec at Baseline. This participant experienced a decrease in QTcF of 30 to <60 msec on Day 30, which then returned to baseline levels on Day 57. | Posted | Number | participants | Baseline through Day 127/Early Termination |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Confirmed Positive Anti-Drug Antibodies (ADAs) | Assays for the determination of a positive immune response was performed. An antibody immune response was defined as a confirmed post-treatment positive enzyme-linked immunosorbent assay (ELISA) result in combination with a negative baseline sample ELISA result. ADA positive was defined as ADA titer (ie, the reciprocal of the highest dilution that gives a value equivalent to the cut point of the assay) >=4.32. | The safety analysis population consists of all participants who received at least 1 dose of study drug. | Posted | Number | participants | Baseline, and Days 15, 29, 57, 85 and Day 127/Early Termination |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Concentration of PF-06342674 | Participants in the placebo arm did not receive PF-06342674. Due to the early termination of the study, the small enrollment number and minimal data, concentration data were listed but not summarized, and pharmacokinetic (PK) parameters were not calculated for the PF-06342674 0.25 mg/kg arm. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/milliliter (ng/ml) | Baseline through Day 127/Early Termination |
|
|
Baseline through Day 127/Early Termination.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo SC every other week during an 85-day treatment period. | 0 | 1 | 0 | 1 | ||
| EG001 | PF-06342674 | Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period. | 0 | 3 | 3 | 3 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
Due to the early termination of the study, the small enrollment number and minimal data, no statistical analyses were performed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days.
Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000710975 | monoclonal antibody RN168 |
Not provided
Not provided
Not provided
| Male |
|
| Withdrawals Due to AEs |
|
|
|
|
|
|
|
|
|