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JNJ-39220675

Phase 2

Allergic Rhinitis | Small molecule | Respiratory |Johnson & Johnson|Trials Updated: Oct 30, 2013

JNJ-39220675 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Dec 2008

JNJ-39220675 target and mechanism

Molecular targetHRH3
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment53

FDA Designations

No designations recorded

JNJ-39220675 clinical trials

JNJ-39220675 · 1 trial · 1 indication

Phase 2 1
NCT00804687An Efficacy Study of JNJ-39220675 and Pseudoephedrine in Participants With Allergic RhinitisAllergic Rhinitis
COMPLETED53 Analytics
PHASE2COMPLETED
An Efficacy Study of JNJ-39220675 and Pseudoephedrine in Participants With Allergic Rhinitis
Allergic RhinitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Baseline Adjusted Area Under the Curve (AUC) of Minimal Cross-Sectional Area (MCA) of Nasal Cavity by Acoustic Rhinometry
2 and 0.5 hour before drug administration and 1, 2, 3, 4, 5, 6, 7 and 8 hours after drug administration at Day 1 of each treatment period

The AcR was an objective measurement of nasal congestion that assessed nasal cavity geometry (that is, MCA) and changes in dimensions of nasal cavity. The AUC of MCA was used as response variable to assess treatment effect. AUC was adjusted for Baseline MCA scores. Baseline MCA was defined as minimum mean MCA at pre-dose (approximately 2 hours before Environmental Exposure Chamber \[EEC\] entry) resulting from 3 measurements on both, left and right nostrils in each of the treatment periods. The AUC of MCA was baseline-adjusted, by subtracting the Baseline value from each of the post-treatment times before calculating the AUC.

Secondary Endpoints

Baseline Adjusted Area Under the Curve (AUC) of Total Nasal Symptom Score (TNSS)
2, 1.5, 1, 0.5 hour before drug administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours after drug administration at Day 1 of each treatment period
Change From Baseline in Total Nasal Symptom Score (TNSS) at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 Hours After Drug Administration at Day 1
0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours after drug administration at Day 1 of each treatment period
Change From Baseline in Minimal Cross-Sectional Area (MCA) at 1, 2, 3, 4, 5, 6, 7 and 8 Hours After Drug Administration at Day 1
Baseline, 1, 2, 3, 4, 5, 6, 7 and 8 hours after drug administration at Day 1 of each treatment period
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
JNJ-39220675 then Pseudoephedrine then PlaceboEXPERIMENTALSingle-dose of JNJ-39220675 will be administered as 1 milliliter (ml) of 10 milligram/milliliter (mg/ml) solution orally along with placebo tablet in first treatment period; after that in second treatment period, single-dose of 1 ml placebo solution will be administered orally along with 60 milligram (mg) pseudoephedrine tablet; and then single-dose of 1 ml placebo solution will be administered orally along with placebo tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.
JNJ-39220675 then Placebo then PseudoephedrineEXPERIMENTALSingle-dose of JNJ-39220675 will be administered as 1 ml of 10 mg/ml solution orally along with placebo tablet in first treatment period; after that, in second treatment period, single-dose of 1 ml placebo solution will be administered orally along with placebo tablet; and then single-dose of 1 ml placebo solution will be administered orally along with 60 mg pseudoephedrine tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.
Placebo then JNJ-39220675 then PseudoephedrineEXPERIMENTALSingle-dose of 1 ml placebo solution will be administered orally along with placebo tablet in first treatment period; after that, in second treatment period, single-dose of JNJ-39220675 will be administered as 1 ml of 10 mg/ml solution orally along with placebo tablet; and then single-dose of 1 ml placebo solution will be administered orally along with 60 mg pseudoephedrine tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.
Placebo then Pseudoephedrine then JNJ-39220675EXPERIMENTALSingle-dose of 1 ml placebo solution will be administered orally along with placebo tablet in first treatment period; after that, in second treatment period, single-dose of 1 ml placebo solution will be administered orally along with 60 mg pseudoephedrine tablet; and then single-dose of JNJ-39220675 will be administered as 1 ml of 10 mg/ml solution orally along with placebo tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.
Pseudoephedrine then JNJ-39220675 then PlaceboEXPERIMENTALSingle-dose of 1 ml placebo solution will be administered orally along with 60 mg pseudoephedrine tablet in first treatment period; after that, in second treatment period, single-dose of JNJ-39220675 will be administered as 1 ml of 10 mg/ml solution along with placebo tablet; and then single-dose of 1 ml placebo solution will be administered orally along with placebo tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.
Pseudoephedrine then Placebo then JNJ-39220675EXPERIMENTALSingle-dose of 1 ml placebo solution will be administered orally along with 60 mg pseudoephedrine tablet in first treatment period; after that, in second treatment period, single-dose of 1 ml placebo solution will be administered orally along with placebo tablet; and then single-dose of JNJ-39220675 will be administered as 1 ml of 10 mg/ml solution orally along with placebo tablet in third treatment period. A washout period of at least 6 days will be maintained between each treatment period.

Interventions

NameTypeDescription
PlaceboOTHERSingle-dose of 1 milliliter (ml) placebo solution will be administered orally and/or placebo tablet orally in one of the treatment periods.
JNJ-39220675DRUGSingle-dose of JNJ-39220675 will be administered as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
PseudoephedrineDRUGSingle-dose of 60 milligram pseudoephedrine tablet will be administered orally in one of the treatment periods.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Participants must have a clinical history of seasonal allergic rhinitis with seasonal onset and offset of nasal allergy symptoms at least during each of the last two ragweed allergy seasons * Participants must have documentation of a positive skin test within 12 months of Scre...

Countries:Canada
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Competitive Landscape -Allergic Rhinitis 8 trials

Top 1 of 3 competitors

CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY1PHASE3LY3650150
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Frequently asked questions about JNJ-39220675

What is JNJ-39220675 used for?

JNJ-39220675 is an investigational small molecule being studied for the treatment of allergic rhinitis. It was evaluated in a Phase 2 clinical trial that enrolled 53 participants with allergic rhinitis. It is not an approved therapy and remains in clinical development for this respiratory indication.

What does JNJ-39220675 target?

JNJ-39220675 targets HRH3, the histamine H3 receptor, and acts as an antagonist at that receptor. By blocking HRH3, the compound is designed to modulate histamine signaling relevant to allergic rhinitis. HRH3 antagonism is the mechanism under investigation for this asset.

Who is developing JNJ-39220675?

JNJ-39220675 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored the Phase 2 study of the compound in allergic rhinitis. Johnson & Johnson is the sole developer identified for this asset.

What phase is JNJ-39220675 in?

JNJ-39220675 is in Phase 2 development. It is an investigational small molecule and has not been approved for any indication. The Phase 2 trial evaluating it in allergic rhinitis has been completed, and no active trials of the compound are currently listed.

What clinical trials is JNJ-39220675 in?

JNJ-39220675 was studied in one completed Phase 2 trial, NCT00804687, titled An Efficacy Study of JNJ-39220675 and Pseudoephedrine in Participants With Allergic Rhinitis. The trial enrolled 53 participants aged 18 years and older in Canada, was randomized and controlled, and included both sexes.