Chronic Idiopathic UrticariaPhase 2NCT03858634
A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases
A Phase 2 study testing KPL-716 in people with Chronic Idiopathic Urticaria and Chronic Idiopathic Pruritus, run by Genentech, Inc. at 14 sites in United States.
Trial summary
Participants with diseases characterized by chronic pruritus experiencing moderate to severe pruritus will be enrolled in this pilot Phase 2 study. The diseases characterized by chronic pruritus investigated in this pilot study currently include chronic idiopathic urticaria (CIU), chronic idiopathic pruritus (CIP)… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Idiopathic Urticaria, Chronic Idiopathic Pruritus, Lichen Planus
- What is being tested?
- KPL-716
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 14 sitesUnited States
- Study dates
- 29 May 2019to 8 Jun 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 to 75 years
- Have clinical diagnosis of chronic idiopathic urticaria (CIU), chronic idiopathic pruritus (CIP), lichen planus (LP), lichen simplex chronicus (LSC) and plaque psoriasis (PPs) for at least 6 months
- Moderate to severe pruritus
- Female participants of childbearing potential must have a negative pregnancy test, be nonlactating, and have agreed to use a highly effective method of contraception, as specified in the protocol, from the Screening Visit until 10 weeks after final study drug administration
- Able to comprehend and willing to sign an Informed Consent Form and able to abide by the study restrictions and comply with all study procedures for the duration of the study
Who cannot join
- Use of prohibited medications within the indicated timeframe from Day 1 to the End of Study
- Is currently using medication known to cause pruritus
- Has any inflammatory, pruritic, and/or fibrotic skin condition other than the diagnosis that defines inclusion
- Laboratory abnormalities that fall outside the windows specified in the protocol at the Screening Visit
- Has an active infection, including skin infection
- Any medical or psychiatric condition which, in the opinion of the Investigator or the Sponsor, may place the participant at increased risk as a result of study participation, interfere with study participation or study assessments, affect compliance with study requirements, or complicate interpretation of study results
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Site 106
Anniston, Alabama, 36207
Site 109
Fort Gratiot, Michigan, 48059
Site 114
Hot Springs, Arkansas, 71913
Site 115
Johnston, Rhode Island, 02919
Site 103
Los Angeles, California, 90045
Site 119
New Orleans, Louisiana, 70115
Site 123
New York, New York, 10012
Site 105
Normal, Illinois, 61761
Site 104
Pflugerville, Texas, 78660
Site 110
Phoenix, Arizona, 85032
Site 112
Plainfield, Indiana, 46168
Site 101
San Antonio, Texas, 78213
Site 122
Spokane, Washington, 99202
Site 113
Sweetwater, Florida, 33172
About this study
Official title: KPL-716-C202: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Pilot Study to Investigate the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Diseases Characterized by Chronic Pruritus
Participants with diseases characterized by chronic pruritus experiencing moderate to severe pruritus will be enrolled in this pilot Phase 2 study.
The diseases characterized by chronic pruritus investigated in this pilot study currently include chronic idiopathic urticaria (CIU), chronic idiopathic pruritus (CIP), lichen planus (LP), lichen simplex chronicus (LSC) and plaque psoriasis (PPs).
- Conditions
- Chronic Idiopathic Urticaria, Chronic Idiopathic Pruritus, Lichen Planus, Lichen Simplex Chronicus, Plaque Psoriasis
- Being tested
- KPL-716, Placebo
- Keywords
- pruritus, chronic pruritus, moderate to severe
- Medical subject headings
- Chronic Urticaria, Lichen Planus, Neurodermatitis, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KPL-716Drug
Also called Vixarelimab, RG6536
A loading dose of KPL-716 720 mg (2x maintenance dose) administered via 2 subcutaneous (SC) injections within 30 minutes on Day 1. All subsequent doses of KPL-716 (360 mg maintenance dose) administered via a single SC injection.
PlaceboDrug
Placebo dose administered via 2 SC injections within 30 minutes on Day 1. All subsequent doses of placebo administered via a single SC injection.
| Study group | Role | What they receive |
|---|---|---|
| KPL-716 | Experimental | Weekly for 8 weeks Receives: Drug: KPL-716 |
| Placebo | Placebo comparator | Weekly for 8 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Weekly Average WI-NRS at Week 8
WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.
Measured: Baseline, Week 8
Percent Change From Baseline in Weekly Average WI-NRS at Week 8
WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.
Measured: Baseline, Week 8
Secondary outcomes (19)
Change From Baseline in Weekly Average WI-NRS Over Time
WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.
Measured: Baseline, Weeks 1-18
Percent Change From Baseline in Weekly Average WI-NRS Over Time
WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.
Measured: Baseline, Weeks 1-18
Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time
Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average pruritus experienced over the previous 3 days using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus.
Measured: Baseline, Weeks 1-8, 10, 12, 14, 16, 18
Percent Change From Baseline in Pruritus VAS Over Time
Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average pruritus experienced over the previous 3 days using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus.
Measured: Baseline, Weeks 1-8, 10, 12, 14, 16, 18
Change From Baseline in 5-D Pruritus Total Score Over Time
This tool evaluates pruritus in 5 domains: duration, degree, direction, disability and distribution. Duration, degree and direction each consist of 1 item. The disability domain contains 4 items and the distribution domain includes 16 items. The first 4 domains are measured on a 5-point Likert scale. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) and 25 (most severe pruritus).
Measured: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18
Percent Change From Baseline in 5-D Pruritus Total Score Over Time
This tool evaluates pruritus in 5 domains: duration, degree, direction, disability and distribution. Duration, degree and direction each consist of 1 item. The disability domain contains 4 items and the distribution domain includes 16 items. The first 4 domains are measured on a 5-point Likert scale. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) and 25 (most severe pruritus).
Measured: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18
Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time
WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.
Measured: Baseline, Weeks 1-18
Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only
Participants were asked daily to self-assess the intensity of their pruritus on a Weekly Average Itch Severity Score, which is a Component of Urticaria Activity Score 7 (UAS7). The score for pruritis was graded from 0 (none) to 3 (intense), which was averaged over 7 consecutive days. The greater the severity of the disease the higher the score. Per protocol, the UAS7 tool was completed only by participants in the CIU Cohort.
Measured: Baseline, Weeks 1-18
Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only
Participants were asked daily to self-assess the intensity of their pruritus on a Weekly Average Itch Severity Score, which is a Component of Urticaria Activity Score 7 (UAS7). The score for pruritis was graded from 0 (none) to 3 (intense), which was averaged over 7 consecutive days. The greater the severity of the disease the higher the score. Per protocol, the UAS7 tool was completed only by participants in the CIU Cohort
Measured: Baseline, Weeks 1-18
Change From Baseline in Sleep Loss VAS Over Time
Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average sleeplessness experienced over the previous 3 nights using a scale from 0 to 10, with 0 indicating no sleeplessness and 10 indicating the worst imaginable sleeplessness at every visit.
Measured: Baseline, Weeks 1-8, 10, 12, 14, 16, 18
Percent Change From Baseline in Sleep Loss VAS Over Time
Participants were asked to place a line perpendicular to the VAS line at the point that represents the intensity of their average sleeplessness experienced over the previous 3 nights using a scale from 0 to 10, with 0 indicating no sleeplessness and 10 indicating the worst imaginable sleeplessness at every visit.
Measured: Baseline, Weeks 1-8, 10, 12, 14, 16, 18
Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time
Participants were asked daily to assign a numerical score to the intensity of their difficulty falling asleep last night due to itch using a scale from 0 to 10, with 0 indicating not difficult at all and 10 indicating extremely difficult.
Measured: Baseline, Weeks 1-18
Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time
Participants were asked daily to assign a numerical score to the intensity of their difficulty falling asleep last night due to itch using a scale from 0 to 10, with 0 indicating not difficult at all and 10 indicating extremely difficult.
Measured: Baseline, Weeks 1-18
Change From Baseline in Weekly Average of Sleep Quality NRS Over Time
Participants were asked daily to assign a numerical score to the quality of their sleep in the previous night using a scale from 0 to 10, with 0 indicating best possible sleep and 10 indicating worst possible sleep.
Measured: Baseline, Weeks 1-18
Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time
Participants were asked daily to assign a numerical score to the quality of their sleep in the previous night using a scale from 0 to 10, with 0 indicating best possible sleep and 10 indicating worst possible sleep.
Measured: Baseline, Weeks 1-18
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time
The DLQI is a 10-question questionnaire that considers symptoms and feelings, daily activities, leisure, school, personal relationships, and treatment. Each question, except question 7, is answered on a scale of 0 to 3 (0 for not at all, 1 for a little, 2 for a lot, and 3 for very much), taking into account the previous week. For question 7: participants were asked "Over the last week, has your skin prevented you from working or studying?" If answered yes, score=3; If no, a second question will be asked: "Over the last week how much has your skin been a problem at work or studying?" If further answered a lot, score=2; if a little, score=1; if not at all or not relevant, score=0. The DLQI total score is defined as the sum of all 10-question scores with minimum of 0 meaning no effect on quality of life and 30 meaning extremely large effect.
Measured: Baseline, Weeks 4, 8, 12, 16, 18
Percent Change From Baseline in DLQI Total Score Over Time
The DLQI is a 10-question questionnaire that considers symptoms and feelings, daily activities, leisure, school, personal relationships, and treatment. Each question, except question 7, is answered on a scale of 0 to 3 (0 for not at all, 1 for a little, 2 for a lot, and 3 for very much), taking into account the previous week. For question 7: participants were asked "Over the last week, has your skin prevented you from working or studying?" If answered yes, score=3; If no, a second question will be asked: "Over the last week how much has your skin been a problem at work or studying?" If further answered a lot, score=2; if a little, score=1; if not at all or not relevant, score=0. The DLQI total score is defined as the sum of all 10-question scores with minimum of 0 meaning no effect on quality of life and 30 meaning extremely large effect.
Measured: Baseline, Weeks 4, 8, 12, 16, 18
Change From Baseline in ItchyQoL Total Score Over Time
ItchyQoL focuses on impact of pruritus on daily activities and on the level of psychological stress. It contains 22 items. The frequency items are scored using a 5-point Likert scale ranging from "never" to "all the time". The bother items are scored from 1 (not bothered) to 5 (severely bothered). The recall period in ItchyQoL is the past week. The ItchyQoL total score is defined as the sum of all 22-items scores. Total scores can be classified as little (0-30), mild (31-50), moderate (51-80), and severe (81-110).
Measured: Baseline, Weeks 4, 8, 12, 16, 18
Percent Change From Baseline in ItchyQoL Total Score Over Time
ItchyQoL focuses on impact of pruritus on daily activities and on the level of psychological stress. It contains 22 items. The frequency items are scored using a 5-point Likert scale ranging from "never" to "all the time". The bother items are scored from 1 (not bothered) to 5 (severely bothered). The recall period in ItchyQoL is the past week. The ItchyQoL total score is defined as the sum of all 22-items scores. Total scores can be classified as little (0-30), mild (31-50), moderate (51-80), and severe (81-110).
Measured: Baseline, Weeks 4, 8, 12, 16, 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start29 May 2019
- Primary completion1 Apr 2020
- Study completion8 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Idiopathic UrticariaStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kiniksa Pharmaceuticals, Ltd.
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858634
- Sponsor's protocol ID
- KPL-716-C202
- Other IDs
- GX45045
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2019
- Last updated
- 18 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KPL-716-C202: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Pilot Study to Investigate the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Diseases Characterized by Chronic Pruritus
- ClinicalTrials.gov ID
- NCT03858634
- Acronym / sponsor ID
- KPL-716-C202
- Conditions
- Chronic Idiopathic Urticaria, Chronic Idiopathic Pruritus, Lichen Planus, Lichen Simplex Chronicus, Plaque Psoriasis
- Keywords
- pruritus, chronic pruritus, moderate to severe
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Kiniksa Pharmaceuticals, Ltd.
- Study start
- 29 May 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 8 Jun 2020 (actual)
- First posted
- 1 Mar 2019 (actual)
- Results
- Posted 28 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants with diseases characterized by chronic pruritus experiencing moderate to severe pruritus will be enrolled in this pilot Phase 2 study.
The diseases characterized by chronic pruritus investigated in this pilot study currently include chronic idiopathic urticaria (CIU), chronic idiopathic pruritus (CIP), lichen planus (LP), lichen simplex chronicus (LSC) and plaque psoriasis (PPs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KPL-716 | Experimental | Drug: KPL-716Weekly for 8 weeks |
| Placebo | Placebo comparator | Drug: PlaceboWeekly for 8 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged 18 to 75 years
- Have clinical diagnosis of chronic idiopathic urticaria (CIU), chronic idiopathic pruritus (CIP), lichen planus (LP), lichen simplex chronicus (LSC) and plaque psoriasis (PPs) for at least 6 months
- Moderate to severe pruritus
- Female participants of childbearing potential must have a negative pregnancy test, be nonlactating, and have agreed to use a highly effective method of contraception, as specified in the protocol, from the Screening Visit until 10 weeks after final study drug administration
- Able to comprehend and willing to sign an Informed Consent Form and able to abide by the study restrictions and comply with all study procedures for the duration of the study
Key exclusion criteria (6 listed)
- Use of prohibited medications within the indicated timeframe from Day 1 to the End of Study
- Is currently using medication known to cause pruritus
- Has any inflammatory, pruritic, and/or fibrotic skin condition other than the diagnosis that defines inclusion
- Laboratory abnormalities that fall outside the windows specified in the protocol at the Screening Visit
- Has an active infection, including skin infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KPL-716Also: Vixarelimab, RG6536A loading dose of KPL-716 720 mg (2x maintenance dose) administered via 2 subcutaneous (SC) injections within 30 minutes on Day 1. All subsequent doses of KPL-716 (360 mg maintenance dose) administered via a single SC injection. | Drug | KPL-716 |
| PlaceboPlacebo dose administered via 2 SC injections within 30 minutes on Day 1. All subsequent doses of placebo administered via a single SC injection. | Drug | Placebo |
Primary outcome
Change From Baseline in Weekly Average WI-NRS at Week 8
Time frame: Baseline, Week 8
WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.
Percent Change From Baseline in Weekly Average WI-NRS at Week 8
Time frame: Baseline, Week 8
WI-NRS score: Participants were asked daily to assign a numerical score to the intensity of their most severe (worst) pruritus in the past 24 hours using a scale from 0 to 10, with 0 indicating no pruritus and 10 indicating the worst imaginable pruritus. Daily scores were averaged for a weekly score. A negative change from Baseline indicates improvement.
19 secondary outcomes
Change From Baseline in Weekly Average WI-NRS Over Time
Time frame: Baseline, Weeks 1-18
Percent Change From Baseline in Weekly Average WI-NRS Over Time
Time frame: Baseline, Weeks 1-18
Change From Baseline in Pruritus Visual Analog Scale (VAS) Over Time
Time frame: Baseline, Weeks 1-8, 10, 12, 14, 16, 18
Percent Change From Baseline in Pruritus VAS Over Time
Time frame: Baseline, Weeks 1-8, 10, 12, 14, 16, 18
Change From Baseline in 5-D Pruritus Total Score Over Time
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18
Percent Change From Baseline in 5-D Pruritus Total Score Over Time
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18
Percentage of Participants Achieving ≥4-Point Reduction From Baseline in Weekly Average WI-NRS Over Time
Time frame: Baseline, Weeks 1-18
Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only
Time frame: Baseline, Weeks 1-18
Percent Change From Baseline in Weekly Average Itch Severity Score: CIU Cohort Only
Time frame: Baseline, Weeks 1-18
Change From Baseline in Sleep Loss VAS Over Time
Time frame: Baseline, Weeks 1-8, 10, 12, 14, 16, 18
Percent Change From Baseline in Sleep Loss VAS Over Time
Time frame: Baseline, Weeks 1-8, 10, 12, 14, 16, 18
Change From Baseline in Weekly Average of Difficulty Falling Asleep Numerical Rating Scale (NRS) Over Time
Time frame: Baseline, Weeks 1-18
Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time
Time frame: Baseline, Weeks 1-18
Change From Baseline in Weekly Average of Sleep Quality NRS Over Time
Time frame: Baseline, Weeks 1-18
Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time
Time frame: Baseline, Weeks 1-18
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time
Time frame: Baseline, Weeks 4, 8, 12, 16, 18
Percent Change From Baseline in DLQI Total Score Over Time
Time frame: Baseline, Weeks 4, 8, 12, 16, 18
Change From Baseline in ItchyQoL Total Score Over Time
Time frame: Baseline, Weeks 4, 8, 12, 16, 18
Percent Change From Baseline in ItchyQoL Total Score Over Time
Time frame: Baseline, Weeks 4, 8, 12, 16, 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KPL-716 in people with Chronic Idiopathic Urticaria and Chronic Idiopathic Pruritus, run by Genentech, Inc. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Weekly Average WI-NRS at Week 8 (time frame: Baseline, Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.