A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Intravenous (IV) Dose of GSK2831781 in Healthy Volunteers and Patients With Plaque Psoriasis

NCT02195349 | Completed Phase 1 Results

• 2 other identifiers: 2006302014-000312-33
• Study Type: interventional
• Target: 67
• Locations: 2 countries
• Sites: 3

Brief Summary

This study is a phase I, randomised, double blind (sponsor unblinded), placebo-controlled, single ascending dose study GSK2831781 administered by IV. GSK2831781 is a humanized Antibody Dependent Cell Cytotoxicity (ADCC) enhanced monoclonal afucosylated antibody that is specific to the Lymphocyte Activation Gene-3 (LAG-3) protein. This is the first administration of GSK2831781 in humans and will evaluate in two parts the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of single IV doses of GSK2831781 administered to healthy subjects previously vaccinated with Bacillus Calmette Guérin (BCG) (Part A delayed type hypersensitivity \[DTH\] cohorts) and patients with plaque psoriasis (Part B). The inclusion of DTH and psoriasis subjects to explore the mechanism in biopsies and clinical response endpoints in these populations, as well as investigate systemic biomarkers will provide useful information prior to conducting studies in other immune-inflammatory disease which will involve more invasive tissue biopsies. Measuring the pharmacology of GSK2831781 using the depletion of LAG-3+ T-cells in skin biopsies from Tuberculin Purified Protein Derivative (PPD) skin challenge and lesional skin biopsies from patients with psoriasis, will be helpful in understanding of the dose response relationship, which will be important for designing future studies in immuno-inflammatory diseases, including psoriasis. Approximately 67 subjects will be enrolled to complete dosing and critical assessments. The subject numbers will be split to approximately 40 healthy subjects (Part A) and 27 patients with psoriasis (Part B).

Conditions

Psoriasis

Keywords

Tuberculin Purified Protein Derivative; Delayed Type Hypersensitivity; Biopsy; Induration; First time in human; T-cells; LAG-3; safety; GSK2831781; psoriasis

Outcome Measures

Primary Outcomes (17)

• Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI)

  Hematology parameters with PCI ranges: hematocrit (high: \>0.54 percentage of red blood cells), hemoglobin (high: \>180 grams per liter \[g/L\]), lymphocytes (low: \<0.8\*giga cells per liter \[10\^9/L\]), neutrophil count (low: \<1.5\*10\^9/L), platelet count (low: \<100\*10\^9/L and high: \>550\*10\^9/L), and while blood cell count (low: \<3\*10\^9/L and high: \>20\*10\^9/L) for healthy volunteers and psoriasis participants. Safety population consisted of all randomized participants who received at least one dose of study treatment. Only those participants for which at least one value of PCI was reported are summarized.

  Up to 307 days

• Number of Participants With Clinical Chemistry Abnormalities of PCI

  Clinical chemistry parameters and their potential clinical concern values: albumin (low: \<30 millimoles per liter \[mmol/L\]), calcium (low: \<2 mmol/L, high: \>2.75 mmol/L), creatinine (high: \>44.2 mmol/L), glucose (low: \<3 mmol/L, high: \>9 mmol/L), magnesium (low: \<0.5 mmol/L, high: \>1.23 mmol/L), phosphorus (low: \<0.8 mmol/L, high: \>1.6 mmol/L), potassium (low: \<3 mmol/L, high: \>5.5 mmol/L), sodium (low: \<130 mmol/L, high: \>150 mmol/L), and total carbon dioxide (CO2) (low: \<18 mmol/L, high: \>32 mmol/L). Number of participants with clinical chemistry of PCI are presented.

  Up to 307 days

• Number of Participants With Vital Signs of PCI

  Vital signs included heart rate, systolic and diastolic blood pressure and body temperature were performed with the participant in a semi-supine position after the participant had rested for at least 5 minutes. The PCI range for heart rate (low: \<40 beats per minute \[BPM\] and high: \>110 BPM), systolic blood pressure (low: \<85 and high: \>160 millimeter of mercury \[mmHg\]), diastolic blood pressure (low: \<45 mmHg and high: \>100 mmHg) and body temperature (low: \<35 degree Celsius and high: \>37.5 degree Celsius). Number of participants with vital signs of PCI are presented.

  Up to 307 days

• Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) of PCI

  Triplicate ECG was measured in a semi-supine position after 5 minutes rest. A single 12-lead ECG was obtained by using an ECG machine that automatically calculates heart rate and measured PR, QRS, QT, and Fridericia's formula (QTcF) intervals. The PCI ranges for QTc Interval (high: \>450 millisecond \[msec\]), PR Interval (low: \<110 msec and high: \>220 msec) and QRS Interval (low: \<75 msec and high: \>110 msec). Number of participants with ECG values of PCI are presented.

  Up to 307 days

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect and other important medical events judged by the investigator that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.

  Up to 307 days

• Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha

  IL-6, IL-8, interferon-gamma and TNF alpha were assessed at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day 1, pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.

  Baseline, 6, 12, 24 and 48 hours post-dose

• Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers

  Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.

  6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 191

• Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)

  Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.

  6, 12, 72, 168 hours, Day 15 and 29

• Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)

  Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.

  6, 12, 72, 168 hours, Days 15, 29 and 43

• Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)

  Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.

  6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57 and 85

• Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)

  Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.

  6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 147

• Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)

  Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.

  6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 219

• Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)

  Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.

  6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 191

• Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo

  Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.

  6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 307

• Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg

  Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.

  6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 237

• Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg

  Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.

  6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 277

• Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg

  Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.

  6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 307

Secondary Outcomes (119)

• Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose

  Baseline, Days 4, 8, 15 and 22 post-dose

• Duration of Induration in the Re-challenge for DTH

  Up to 28 days post-dose

• Change From Baseline (PPD First Challenge) of Lymphocyte Activation Gene-3 (LAG-3)+ Cells in Biopsies of Re-challenged Skin at 3 Days Post-dose

  Baseline and 72 hours post-dose

• Change From Baseline in LAG-3+ Cells in Lesional Biopsies in Psoriasis Participants at Day 29

  Baseline and Day 29

• Area Under the Plasma Time Curve From Zero to Infinity (AUC[0-infinity]) of GSK2831781 0.0003 mg/kg (ADA-ve)

  Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose

Study Arms (3)

Healthy Subjects (no DTH)

EXPERIMENTAL

One subject will be dosed with GSK2831781 (0.0003 mg/kg) and one with placebo. Depending on the safety data obtained for 28 days post dose along with the available PK data, a dose escalation may be done to the next planned dose (0.0015 , 0.0075, 0.04, 0.15 mg/kg). In case safety findings are noted then the cohort may be expanded to a maximum cohort size of 6:3 (GSK2831781: placebo) or the escalation will be stopped.

Biological: GSK2831781; Biological: Placebo

Healthy Subjects (DTH)

EXPERIMENTAL

Sentinel subjects (one dosed with GSK2831781 (0.0003 mg/kg) and one with placebo) will be used in the cohort. Following a review of safety data up to 48 hours post dose, an additional 5 active (GSK2831781) and 1 placebo subject will be dosed (no more than 2 subjects per day with dosing separated by at least 1 hour). After reviewing the safety data for 28 days the healthy subjects (DTH) will be escalated to the planned dose of GSK2831781 (0.0075, 0.04, 0.15 mg/kg) in 6:3 ratio with placebo.

Biological: GSK2831781; Biological: Placebo

Subjects with Psoriasis

EXPERIMENTAL

Sentinel subjects (one dosed with GSK2831781 and one with placebo) will be used in the cohort. Following a review of safety data up to 48 hours post dose, an additional 5 active (GSK2831781) and 2 placebo subjects will be dosed (no more than 2 subjects per day with dosing separated by at least 1 hour). All subsequent cohorts do not require stratification for pre-existing ADAs. After reviewing the safety data for 28 days for minimum of 8 out of 9 subjects within the cohort and all subjects have completed dosing and the inpatient monitoring until Day 4, the subjects with psoriasis will be escalated to the planned dose of GSK2831781 (1.5 and 5 mg/kg) in 6:3 ratio with placebo.

Biological: GSK2831781; Biological: Placebo

Interventions

GSK2831781 BIOLOGICAL

GSK2831781 (100 milligram (mg)/mL) and its dilutions (Diluent - 0.9 percent saline solution containing 0.015 percent Polysorbate 80) as clear or opalescent, colourless, yellow to brown liquid solution administered by IV over approximately 2 hours.

Healthy Subjects (DTH); Healthy Subjects (no DTH); Subjects with Psoriasis

Placebo BIOLOGICAL

Commercial saline solution administered by IV over approximately 2 hours

Healthy Subjects (DTH); Healthy Subjects (no DTH); Subjects with Psoriasis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Part A males aged between 18 and 65 years of age and Part B males and females aged between 18 and 75 years of age inclusive, at the time of signing the informed consent
• Part A: A body weight \<=120 kilogram (kg) and Body mass index (BMI) within the range 19-32 kg/square meter (m\^2) (inclusive), Part B: BMI within range 19-35 kg/m\^2 (inclusive).
• Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin \<=1.5x Upper limit of normal (ULN) (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent)
• Based on single or averaged Electrocardiogram QT interval corrected for heart rate (QTc) values of triplicate Electrocardiogram (ECGs) obtained over a brief recording period: Electrocardiogram QT interval corrected for heart rate using Fridericia's formula (QTcF) \<450 milliseconds (msec)
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
• For Part A study subjects only

You may not qualify if:

• Delayed type hypersensitivity (DTH) cohorts only
• Subjects with a history of Bacillus Calmette Guérin (BCG) vaccination as evidence by either: A BCG scar and verbal confirmation of BCG vaccination ; Or documented medical history of a BCG vaccination with or without a BCG scar
• Subjects with a history of current vaccination for Tetanus, diphtheria, measles, pertussis, mumps and rubella
• For Part B study subjects only
• Subject has psoriasis covering Body Surface Area (BSA) \>=3 percent as assessed at Screening and Day-1
• Subject has had a confirmed diagnosis of chronic plaque-type psoriasis (without recent documented flare within 30 days prior to screening) for at least 6 months
• Subject has at least 2 stable plaques assessed at Screening and Day -1. One of a suitable size and in a site suitable for repeat biopsy, and one for index lesion Plaque Lesional Severity Score (PLSS) scoring. Both must have a PLSS lesional score of \>=2 for the induration component (moderate or above), \>=1 for erythema and scaling with a total score of \>=5. The biopsy lesion must not be on the face, groin or scalp and must be protected from the sun
• A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin (hCG) test at screening and negative urine hCG test at Day -1 for Females of Reproductive Potential \[FRP\]), not lactating, and at least one of the given conditions applies: Non-reproductive potential defined as pre-menopausal females with a documented tubal ligation; or documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; or hysterectomy; or documented bilateral oophorectomy.
• Postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels)\]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.
• Reproductive potential and agrees to use a barrier method (male condom or female diaphragm) plus to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in FRP from 28 days prior to the first dose of study medication and until completion of the follow-up visit.
• The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. The investigator or designee should remind the subjects of the need to comply with these requirements approximately monthly, either at study visits or by telephone call until the follow-up visit.
• Received live vaccine (s) attenuated or recombinant within 4 weeks of Day 1 or plan to receive a live vaccination during the study until follow-up
• Subjects from a high risk area of the world for tuberculosis or have history of tuberculosis or have close family members with confirmed Mycobacterium tuberculosis (MTB) infection or positive at screening by Quantiferon testing
• Subject is unable to abstain from travelling to areas with high endemic rates of infectious diseases until the end of the follow up period
• A medical history of severe allergic reaction, angio-edema, anaphylaxis or immunodeficiency

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Parexel: collaborator

Study Sites (3)

GSK Investigational Site

Bonn, North Rhine-Westphalia, 53127, Germany

Location

GSK Investigational Site

Berlin, 14050, Germany

Location

GSK Investigational Site

London, United Kingdom

Location

Related Publications (1)

• Ellis J, J B Marks D, Srinivasan N, Barrett C, Hopkins TG, Richards A, Fuhr R, Albayaty M, Coenen M, Liefaard L, Leavens K, Nevin KL, Tang S, Hughes SA, Fortunato L, Edwards K, Cui Y, Anselm R, Delves CJ, Charles E, Feeney M, Webb TM, Brett SJ, Schmidt TS, Stone J, Savage COS, Wisniacki N, Tarzi RM. Depletion of LAG-3+ T Cells Translated to Pharmacology and Improvement in Psoriasis Disease Activity: A Phase I Randomized Study of mAb GSK2831781. Clin Pharmacol Ther. 2021 May;109(5):1293-1303. doi: 10.1002/cpt.2091. Epub 2020 Nov 24.

  PMID: 33113155 BACKGROUND

MeSH Terms

Conditions

Psoriasis; Hypersensitivity, Delayed

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 21, 2014
• Study Start: July 30, 2014
• Primary Completion: March 7, 2018
• Study Completion: March 7, 2018
• Last Updated: March 25, 2021
• Results First Posted: August 16, 2019

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

DE (2); GB (1)