Clinical Trial Details
| Trial ID: | L1240 |
| Source ID: | NCT05075408 |
| Associated Drug: | Nemolizumab |
| Title: | To Evaluate the Efficacy and Safety of Nemolizumab for 12 Weeks in Participants With Chronic Kidney Disease With Associated Moderate to Severe Pruritus |
| Acronym: | NIKAIA 1 |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT05075408/results |
| Conditions: | Chronic Kidney Disease Associated Moderate to Severe Pruritus |
| Interventions: | DRUG: Nemolizumab|DRUG: Nemolizumab|DRUG: Placebo |
| Outcome Measures: | Primary: Percentage of Responders With an Improvement of Worst Itch Numeric Rating Scale (WI NRS) Greater Than and Equal to (>=) 4 From Baseline at Week 12, Responders are defined as participants with an improvement of \>= 4 in WI NRS from baseline at Week 12 without use of rescue therapies and without treatment discontinuation due to lack of efficacy or Adverse event(AE)/death related to study drug. The WI NRS is a scale that is used by responders to report intensity of their worst pruritus (itch) during last 24 hours. Participants were asked following question: For worst itch intensity:"On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Higher scores indicated worse outcome. Percentage of responders with an improvement of WI NRS \>= 4 from Baseline at Week 12 is reported here. Missing data due to discontinuation from the study prior to Week 12 or any other reason (e.g., insufficient eDiary completion) were imputed using multiple imputation under missing at random assumption (results were combined using Rubin's formulae)., Baseline, Week 12 | Secondary: Percentage of Responders With an Improvement of WI NRS >= 3 From Baseline at Week 12, Responders are defined as participants with an improvement of \>= 3 in WI NRS from baseline at Week 12 without use of rescue therapies and without treatment discontinuation due to lack of efficacy or AE/death related to study drug. The WI NRS is a scale that is used by the responders to report the intensity of their worst pruritus (itch) during the last 24 hours. Participants were asked the following question: For worst itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Higher scores indicated worse outcome. Percentage of responders with an improvement of WI NRS \>= 3 from Baseline at Week 12 is reported here. Missing data due to discontinuation from the study prior to Week 12 or any other reason (e.g., insufficient eDiary completion) were imputed using multiple imputation under missing at random assumption (results were combined using Rubin's formulae)., Baseline, Week 12|Percentage of Responders With an Improvement of WI NRS >= 4 From Baseline at Week 4, Responders are defined as participants with an improvement of \>= 4 in WI NRS from baseline at Week 4 without use of rescue therapies and without treatment discontinuation due to lack of efficacy or AE/death related to study drug. The WI NRS is a scale that is used by the responders to report the intensity of their worst pruritus (itch) during the last 24 hours. Participants were asked the following question: For worst itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Higher scores indicated worse outcome. Percentage of responders with an improvement of WI NRS \>= 4 from Baseline at Week 4 is reported here. Missing data due to discontinuation from the study prior to Week 4 or any other reason (e.g., insufficient eDiary completion) were imputed using multiple imputation under missing at random assumption (results were combined using Rubin's formulae)., Baseline, Week 4|Percentage of Responders With an Improvement of Sleep Disturbance Numerical Rating Scale (SD NRS) >= 4 From Baseline at Week 12, Responders are participants with an improvement \>= 4 in SD NRS from baseline at Week 12 without use of rescue therapies and without treatment discontinuation due to lack of efficacy or AE/death related to study drug. SD NRS is a scale used by participants to report degree of their sleep loss related to chronic kidney disease with associated pruritus (CKD-aP ). Participants were asked following question: "On a scale of 0 to 10, with 0 being 'no sleep loss related to the symptoms of pruritus' and 10 being 'I did not sleep at all due to the symptoms of pruritus', how would you rate your sleep last night?". Higher scores indicated worse outcome. Percentage of responders with an improvement of SD NRS \>= 4 from Baseline at Week 12 is reported here. Missing data due to discontinuation from study prior to Week 12 or any other reason (e.g., insufficient eDiary completion) were imputed using multiple imputation under missing at random assumption (results were combined using Rubin's formulae)., Baseline, Week 12|Percentage of Responders With an Improvement of WI NRS >= 3 From Baseline at Week 4, Responders are defined as participants with an improvement of \>= 3 in WI NRS from baseline at Week 4 without use of rescue therapies and without treatment discontinuation due to lack of efficacy or AE/death related to study drug. The WI NRS is a scale that is used by the responders to report the intensity of their worst pruritus (itch) during the last 24 hours. Participants were asked the following question: For worst itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Higher scores indicated worse outcome. Percentage of responders with an improvement of WI NRS \>= 3 from Baseline at Week 4 is reported here. Missing data due to discontinuation from the study prior to Week 4 or any other reason (e.g., insufficient eDiary completion) were imputed using multiple imputation under missing at random assumption (results were combined using Rubin's formulae)., Baseline, Week 4|Percentage of Responders With an Improvement of SD NRS >= 4 From Baseline at Week 4, Responders are defined as participants with an improvement \>= 4 in SD NRS from baseline at Week 4 without use of rescue therapies and without treatment discontinuation due to lack of efficacy or AE/death related to study drug. The SD NRS is a scale used by participants to report the degree of their sleep loss related to CKD-aP. Participants were asked the following question: "On a scale of 0 to 10, with 0 being 'no sleep loss related to the symptoms of pruritus' and 10 being 'I did not sleep at all due to the symptoms of pruritus', how would you rate your sleep last night?". Higher scores indicated worse outcome. Percentage of responders with an improvement of SD NRS \>= 4 from Baseline at Week 4 is reported here. Missing data due to discontinuation from the study prior to Week 4 or any other reason (e.g., insufficient eDiary completion) were imputed using multiple imputation under missing at random assumption (results were combined using Rubin's formulae)., Baseline, Week 4 |
| Sponsor/Collaborators: | Sponsor: Galderma R&D |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2|PHASE3 |
| Enrollment: | 258 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT |
| Start Date: | 2021-12-29 |
| Completion Date: | 2024-01-04 |
| Results First Posted: | 2025-02-20 |
| Last Update Posted: | 2025-02-20 |
| Locations: | Galderma Investigational Site 9989, Bakersfield, California, 93309, United States|Galderma Investigational Site 9991, Glendale, California, 91205, United States|Galderma Investigational Site 7018, Glendale, California, 91206, United States|Galderma Investigational Site 7015, La Palma, California, 90623, United States|Galderma Investigational Site 9996, Los Angeles, California, 90048, United States|Galderma Investigational Site 9978, Lynwood, California, 90262, United States|Galderma Investigational Site 7017, Riverside, California, 92505, United States|Galderma Investigational Site 9973, Tarzana, California, 91356, United States|Galderma Investigational Site 7028, Victorville, California, 92392, United States|Galderma Investigational Site 9964, Victorville, California, 92394-1868, United States|Galderma Investigational Site 7003, Whittier, California, 90603, United States|Galderma Investigational Site 9971, Denver, Colorado, 80230, United States|Galderma Investigational Site 9988, Bloomfield, Connecticut, 06002, United States|Galderma Investigational Site 9980, Middlebury, Connecticut, 06762, United States|Galderma Investigational Site 9970, Boca Raton, Florida, 33421, United States|Galderma Investigational Site 7037, Coral Gables, Florida, 33134, United States|Galderma Investigational Site 7026, Hollywood, Florida, 33021, United States|Galderma Investigational Site 9965, Miami, Florida, 33125, United States|Galderma Investigational Site7016, Miami, Florida, 33155, United States|Galderma Investigational Site 7032, Sanford, Florida, 32771, United States|Galderma Investigational Site 7004, Tampa, Florida, 33603, United States|Galderma Investigational Site 7025, Tampa, Florida, 33603, United States|Galderma Investigational Site 7027, Columbus, Georgia, 31904, United States|Galderma Investigational Site 9983, Overland Park, Kansas, 66210, United States|Galderma Investigational Site 9972, Wichita, Kansas, 67214, United States|Galderma Investigational Site 9963, Roseville, Michigan, 48066, United States|Galderma Investigational Site 7020, Edina, Minnesota, 55435, United States|Galderma Investigational Site 9982, Minneapolis, Minnesota, 55404, United States|Galderma Investigational Site 7035, Kansas City, Missouri, 64111, United States|Galderma Investigational Site 9962, Las Vegas, Nevada, 89128, United States|Galderma Investigational Site 9995, Bronx, New York, 10461, United States|Galderma Investigational Site 7038, Fresh Meadows, New York, 11365, United States|Galderma Investigational Site 9998, Great Neck, New York, 11021, United States|Galderma Investigational Site 7007, Winston-Salem, North Carolina, 27103, United States|Galderma Investigational Site 9992, Roseburg, Oregon, 97471, United States|Galderma Investigational Site 9999, Spartanburg, South Carolina, 29306, United States|Galderma Investigational Site 9967, Chattanooga, Tennessee, 37404, United States|Galderma Investigational Site 7039, Arlington, Texas, 76015, United States|Galderma Investigational Site 7040, Dallas, Texas, 75231, United States|Galderma Investigational Site 9966, El Paso, Texas, 79925, United States|Galderma Investigational Site 9977, Greenville, Texas, 75402, United States|Galderma Investigational Site 7011, Houston, Texas, 77054, United States|Galderma Investigational Site 7022, McKinney, Texas, 75069, United States|Galderma Investigational Site 7010, San Antonio, Texas, 78258, United States|Galderma Investigational Site 7019, The Woodlands, Texas, 77384, United States|Galderma Investigational Site 9968, Norfolk, Virginia, 23502, United States|Galderma Investigational Site 9969, Wauwatosa, Wisconsin, 53226, United States|Galderma Investigational Site 6301, Budapest, 1076, Hungary|Galderma Investigational Site 6304, Kecskemét, 6000, Hungary|Galderma Investigational Site 6305, Miskolc, 3526, Hungary|Galderma Investigational Site 6310, Szentes, 6600, Hungary|Galderma Investigational Site 6298, Szombathely, 9700, Hungary|Galderma Investigational Site 6294, Brodnica, 87-300, Poland|Galderma Investigational Site 6293, Olkusz, 32-300, Poland|Galderma Investigational Site 6297, Wrocław, 50-556, Poland|Galderma Investigational Site 6296, Łódź, 90-153, Poland|Galderma Investigational Site 6309, Alcobendas, 28108, Spain|Galderma Investigational Site 6292, Córdoba, 14004, Spain|Galderma Investigational Site 5580, L'Hospitalet De Llobregat, 08097, Spain|Galderma Investigational Site 5171, Madrid, 28040, Spain|Galderma Investigational Site 6190, Madrid, 28046, Spain|Galderma Investigational Site 6278, Manises, 46940, Spain|Galderma Investigational Site 6295, Sevilla, 41009, Spain|Galderma Investigational Site 6311, Valencia, 46017, Spain |
| URL: | https://clinicaltrials.gov/show/NCT05075408 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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