Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-39220675 · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| JNJ-39220675 then Pseudoephedrine then Placebo | EXPERIMENTAL | Single-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 Pseudoephedrine | EXPERIMENTAL | Single-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 Pseudoephedrine | EXPERIMENTAL | Single-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-39220675 | EXPERIMENTAL | Single-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 Placebo | EXPERIMENTAL | Single-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-39220675 | EXPERIMENTAL | Single-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. |
| Name | Type | Description |
|---|---|---|
| Placebo | OTHER | Single-dose of 1 milliliter (ml) placebo solution will be administered orally and/or placebo tablet orally in one of the treatment periods. |
| JNJ-39220675 | DRUG | Single-dose of JNJ-39220675 will be administered as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods. |
| Pseudoephedrine | DRUG | Single-dose of 60 milligram pseudoephedrine tablet will be administered orally in one of the treatment periods. |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE3 | LY3650150, Standard therapy for INCS |
| Polyrizon Ltd. | PLRZ | 1 | N/A | Undisclosed |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | - | Undisclosed |
JNJ-39220675 is an investigational small molecule being developed for the treatment of allergic rhinitis. It has been studied in a Phase 2 clinical trial in Canada, which has been completed. The drug is not approved and remains in clinical development.
JNJ-39220675 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is an investigational small molecule intended for allergic rhinitis and has completed a Phase 2 trial.
JNJ-39220675 is in Phase 2 clinical development. A Phase 2 trial, NCT00804687, has been completed. The drug is investigational and has not been approved for any use.
JNJ-39220675 has one completed Phase 2 clinical trial, NCT00804687, titled "An Efficacy Study of JNJ-39220675 and Pseudoephedrine in Participants With Allergic Rhinitis." The trial enrolled 53 participants in Canada and was a controlled, randomized study.
JNJ-39220675 is not FDA approved. It is an investigational drug that has completed a Phase 2 clinical trial for allergic rhinitis. The drug remains in clinical development and has not been approved for marketing.