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Pollen allergen extract

Phase 2

Asthma and Rhinitis | Unknown | Respiratory |GSK plc|Last Updated: Apr 4, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02446613Follow-up Study to Investigate the Effect of GSK2245035 on Nasal Allergic Reactivity in Subjects Completing Treatment in Study TL7116958PHASE2 COMPLETED 16Jun 22, 2015Aug 10, 2015Apr 4, 20181 Canada
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Study Endpoints
Primary Endpoints
Mean Change From Baseline in the Total Nasal Sym. Score (TNSS) at Post-NAC 15 Minutes (Min)
Day 1 (Baseline [pre-NAC] and post-NAC 15 min)

TNSS was obtained from 4 individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym. scores were combined to produce a TNSS. TNSS were reported as median (credible interval). The baseline values were the latest pre-dose assessments. Change from baseline was measured as the value recorded at 15 min post-NAC minus Baseline value.

Mean Change From Baseline in the TNSS Over Post-NAC 1 h
Day 1 (Baseline [pre-NAC], 15 to post-NAC 1h)

TNSS was obtained from 4 individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym scores were combined to produce a TNSS. TNSS were reported as median (credible interval). The baseline values were the latest pre-dose assessments. Change from baseline was measured as the value recorded at a specified time point minus Baseline value. Weighted mean (WM) 0-1h of 15, 30 min and 1 h was reported.

Mean Change From Baseline in the TNSS Over Post-NAC 6 h
Day 1 (Baseline [pre-NAC] to post-NAC 6 h)

TNSS was obtained from 4 individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym scores were combined to produce a TNSS. TNSS were reported as median (credible interval). The baseline values were the latest pre-dose assessments. Change from baseline was measured as value recorded at a specified time point minus Baseline value. WM 0-6 h of 15, 30 min, 1, 2, 3, 4, 5, 6h was reported.

Maximum (Max) Mean Change From Baseline (BL) in the TNSS Over Post-NAC 6 h
Day 1 (Baseline [pre-NAC] to post-NAC 6 h)

TNSS was obtained from 4 individual nasal sym.: nasal congestion, rhinorrhoea, nasal itch and sneezing. Par rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym. scores were combined to produce a TNSS. TNSS were reported as median (credible interval). BL values were the latest pre-dose assessments. Change from BL was measured as the value recorded at a specified time point minus BL value. The max change from BL from the set of individual PNIF % reduction measurements made over the 0 to 6 h sampling period.

Percent Change From Baseline in the Peak Nasal Inspiratory Flow (PNIF) at Post-NAC 15 Min
Day 1 (Baseline [pre-NAC] and post-NAC 15 min)

PNIF data recorded at Baseline pre-challenge and at 15, 30 min and 1h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. The baseline value were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). WM 0-1 h of 15, 30 min and 1 h was reported. WM were derived by first calculating the AUC using the trapezoidal rule, and then dividing by the time interval. If available, actual times were used in the calculation, otherwise planned relative times were used for the calculation.

Percent Change From Baseline in the PNIF Over Post-NAC 1 h
Day 1 (Baseline [pre-NAC] to post-NAC 1 h)

PNIF data recorded at Baseline pre-challenge and at 15, 30 min and 1h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). WM 0-1 h of 15, 30 min and 1 h was reported. WM were derived by first calculating the AUC using the trapezoidal rule, and then dividing by the time interval. If available, actual times were used in the calculation, otherwise planned relative times were used for the calculation.

Percent Change From Baseline in the PNIF up to Post-NAC 6 h
Day 1 (Baseline [pre-NAC] to post-NAC 6 h)

PNIF data recorded at Baseline pre-challenge and at 15, 30 min, 1, 2, 3, 4, 5, 6h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). WM 0-6h of 15, 30 min, 1, 2, 3, 4, 5, 6h was reported. WM were derived by first calculating the AUC using the trapezoidal rule, and then dividing by the time interval. If available, actual times were used in the calculation, otherwise planned relative times were used for the calculation.

Maximum Percent Change From Baseline in PINF Over Post-NAC 6 h
Day 1 (Baseline [pre-NAC] to post-NAC 6 h)

PNIF data recorded at Baseline pre-challenge and at 15, 30 min, 1, 2, 3, 4, 5, 6h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). Maximum change from Baseline till 6h was reported.

Secondary Endpoints
Mean Change From Baseline in Individual Nasal Sym. Including Sneezing, Nasal Congestion, Rhinorrhoea and Nasal Itch.
Day 1 (Baseline [pre-NAC] to post-NAC 6 h)
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Study Design & Arms
AllocationNA
MaskingSINGLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Nasal allergen challengeOTHERSubjects do not receive study medication in this study 204509. Subjects who carried from study TL7116958 treatment group GSK2245035 will undergo NAC with pollen allergen extract.
Interventions
NameTypeDescription
Pollen allergen extractOTHERPollen (tree, grass or ragweed) allergen extracts will be provided by the research unit and diluted as required in normal saline. The specific pollen allergen extract that will be used for the nasal allergen challenge will be selected according to each subject's individual allergic sensitivity demonstrated in the previous study, TL7116958. If possible, extracts remaining from this study in 2014 will be used, provided they have not reached their expiry date.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Adult subjects with allergic rhinitis who completed study TL7116958 in 2014. * Healthy as determined by the investigator or medically qualified designee based on a brief physical examination. * Males and non-pregnant females. * Capable of giving signed informed consent which i...

Countries:Canada
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