Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LiRIS · 3 trials · 4 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. |
| 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. |
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 an investigational small molecule being developed for interstitial cystitis, also known as bladder pain syndrome. It has been studied in women with interstitial cystitis, including those with Hunner's lesions, which are ulcerations in the bladder wall. The drug is delivered locally to the bladder to treat this chronic condition.
LiRIS is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug is in clinical development for interstitial cystitis, a chronic bladder condition. AbbVie has sponsored multiple clinical trials evaluating LiRIS in female patients.
LiRIS is an investigational drug that has completed Phase 1 and Phase 2 clinical trials. It is not approved by the FDA and remains in clinical development. The completed trials evaluated safety, tolerability, and preliminary efficacy in women with interstitial cystitis, including those with Hunner's lesions.
LiRIS has been studied in four completed clinical trials. These include NCT01150565 and NCT01879683, which were Phase 1 safety studies in women with interstitial cystitis. Two Phase 2 trials, NCT02395042 and NCT02411110, evaluated safety and efficacy in women with interstitial cystitis, including those with Hunner's lesions and bladder pain syndrome.
LiRIS is designed for local delivery to the bladder. Clinical trials enrolled women aged 18 years and older with interstitial cystitis. The studies were conducted in the United States and Canada. The drug was evaluated as a treatment for interstitial cystitis, including cases with Hunner's lesions.
LiRIS is a distinct investigational small molecule developed specifically for interstitial cystitis. It has been studied in women with this condition, including those with Hunner's lesions. No alternative names for LiRIS have been reported in clinical trial records.