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LiRIS · 4 trials · 5 indications
The participant recorded their bladder pain over the previous 24-hour period in a 7-day pain assessment tool using an 11-point Numeric Rating Scale (NRS) (0 to 10) where 0=no pain to 10= worst pain. Pain data recorded over the 7-day period were averaged. A negative change from Baseline indicates improvement. An Analysis of Covariance (ANCOVA) model with baseline value as a covariate and treatment group and stratification factors (age group: \< 40 years or ≥ 40 years and baseline bladder pain NRS: ≤ 6 or \> 6) as factors was used for analysis.
The participant recorded their daily bladder pain score over the previous 24-hour period on a 7-day pain assessment tool as measured by an NRS on an 11-point scale where 0=no pain to 10=worst pain imaginable. The daily pain scores over the 7-day period were averaged. A negative change from Baseline indicates improvement. An analysis of covariance (ANCOVA) model with Baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or \> 5) as factors was used for analysis.
The appearance of the Hunner's lesions was assessed by the investigator using video capture of the bladder mucosa during the cystoscopic examinations. Complete responders (CR)=no lesions observed at day of last LiRIS removal; Partial responders (PR)=presence of residual lesions on day of last LiRIS removal however there is cystoscopic evidence of a decrease in either: i) the affected area as calculated by size and dimension of individual lesions summed together or ii) the lesion number or iii) the lesion(s) severity (mild, moderate, severe) as compared with Baseline assessment; Stable Disease=no change in the appearance of lesions and no new lesions on day of last LiRIS removal compared with Baseline assessment; Non-responders=worsening of mucosal appearance on day of last LiRIS removal.
The appearance of the Hunner's lesions was assessed by the investigator using video capture of the bladder mucosa during the cystoscopic examinations. Complete responders (CR)=no lesions observed at day of last LiRIS removal; Partial responders (PR) = presence of residual lesions on day of last LiRIS removal however there is cystoscopic evidence of a decrease in either i) the affected area as calculated by size and dimension of individual lesions summed together or ii) the lesion number or iii) the lesion(s) severity (mild, moderate, severe) as compared with Baseline assessment; Stable Disease=no change in the appearance of lesions and no new lesions on day of last LiRIS removal compared with Baseline assessment; Non-responders=worsening of mucosal appearance on day of last LiRIS removal.
| Arm | Type | Description |
|---|---|---|
| LiRIS® (Treatment Period 1)/LiRIS® (Treatment Period 2) | EXPERIMENTAL | Treatment Period 1: continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2. |
| LiRIS Placebo (Treatment Period 1)/LiRIS® (Treatment Period 2) | OTHER | Treatment period 1: Matching placebo device to LiRIS inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 1. Treatment Period 2: optional continuous release of lidocaine inserted into the bladder by cystoscopy on Day 0 and removed on Day 14 of Period 2. |
| LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2) | PLACEBO_COMPARATOR | Treatment 1 Period (Tx 1): Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Treatment 2 Period (Tx 2): optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14. |
| LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2) | EXPERIMENTAL | Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and then removed on Day 14. |
| LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2) | EXPERIMENTAL | Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. Treatment 2 Period: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 then removed on Day 14. |
| LiRIS® 400 mg | EXPERIMENTAL | LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period. |
| LiRIS low dose | EXPERIMENTAL | The first dose group of approximately 10 patients receive low dose LiRIS on Day 1 to Day 14. |
| LiRIS high dose | EXPERIMENTAL | The second dose group of approximately 10 patients receive high dose LiRIS on Day 1 to Day 14. |
| Name | Type | Description |
|---|---|---|
| LiRIS® | COMBINATION_PRODUCT | LiRIS® is a drug-device combination product which is placed in the bladder during cystoscopy and remains in the bladder, gradually releasing lidocaine until removed from the bladder via cystoscopy. |
| LiRIS Placebo | COMBINATION_PRODUCT | LiRIS placebo is a drug-device combination product, matching the LiRIS® which is placed in the bladder during cystoscopy, remains in the bladder until removed from the bladder via cystoscopy. |
| LiRIS® 400 mg | DRUG | LiRIS® 400 mg is a drug-device combination product which is placed in the bladder during cystoscopy, remains in the bladder for up to 14 days gradually releasing lidocaine, and removed from the bladder via cystoscopy. |
| LiRIS low dose and LiRIS high dose | DRUG | Drug delivery system containing lidocaine; LiRIS (low or high dose) is inserted into bladder via cystoscopy on Day 1 and removed via cystoscopy on Day 14. Designed to release lidocaine over a 14 day period. |
Inclusion Criteria: * Diagnosis of interstitial cystitis or bladder pain syndrome Exclusion Criteria: * Diagnosis of interstitial cystitis with Hunner's lesions/ulcers * Previous treatment with LiRIS®
LiRIS is being developed for the treatment of interstitial cystitis, also called bladder pain syndrome, including chronic interstitial cystitis and cases with Hunner's lesions. It is an investigational therapy studied in adult women. LiRIS has not been approved for commercial use and remains in clinical development.
LiRIS is developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie holds the development program for this investigational interstitial cystitis therapy.
LiRIS is in Phase 1 development according to its overall program status, though individual studies have reached Phase 2. It is investigational and has not been approved by the FDA. All four listed trials are completed, and no trials are currently active.
LiRIS has been studied in completed trials including NCT02411110 and NCT02395042, both Phase 2 studies in women with interstitial cystitis, plus Phase 1 studies NCT01879683 and NCT01150565. Total enrollment across these trials was 208 participants, conducted in the United States and Canada.
LiRIS is being evaluated as a treatment for interstitial cystitis, a chronic bladder pain condition, including patients with Hunner's lesions. The completed trials enrolled adult women aged 18 and older. It is an investigational small molecule therapy and is not approved for treating interstitial cystitis.