Chronic PruritusPhase 2BLUEPRINTNCT04693195
A Multiple-Dose Study of BLU-5937 in Chronic Pruritus Associated With Atopic Dermatitis
A Phase 2 study testing BLU-5937 in people with Chronic Pruritus and Atopic Dermatitis, run by Bellus Health Inc. - a GSK company at 33 sites in 2 countries.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel design study of BLU-5937 for the treatment of chronic pruritus in adult subjects with atopic dermatitis (AD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pruritus, Atopic Dermatitis
- What is being tested?
- BLU-5937
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 33 sitesin 2 countries
- Study dates
- 9 Dec 2020to 12 Oct 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Willing to participate and is capable of giving informed consent
- Clinically confirmed diagnosis of active AD with at least a 6-month history of AD
- Chronic pruritus related to AD for at least 3 months
- Moderate to severe itch associated with mild to moderate AD
- Female of childbearing potential must agree to use a highly effective contraceptive method during the study and until at least 4 weeks after the last study drug administration
Who cannot join
- History of skin disease or presence of skin condition that would interfere with the study assessments
- Clearly defined etiology for pruritus other than AD, including but not limited to: urticaria, psoriasis, or other non-atopic dermatologic conditions, hepatic or renal disease, psychogenic pruritus, drug reaction, uncontrolled hyperthyroidism, and infection
- Presence of any acute skin condition other than AD which may risk inducing a pruritus flare/worsening during the course of the study, including but not limited to: impetigo, active herpes simplex infection, or allergic contact dermatitis
- Subject is >65 years of age and has developed pruritus at age of ≥50 years
- History of cancer or lymphoproliferative disease within 5 years with the exception of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix
- Known history of, or active, parasitic infection, including skin parasites such as scabies within 12 months prior to Screening
Show all 9Show fewer
- Known history of chronic infectious disease (e.g. hepatitis B, hepatitis C, or human immunodeficiency virus [HIV])
- Known history of clinically significant drug or alcohol abuse in the last year
- Previous participation in a BLU-5937 trial
Trial locations and contacts
33 sites in 2 countries.
33 sites in 2 countries
United States28 sites
Bellus Health Investigational Site #12
Austin, Texas, 78759
Bellus Health Investigational Site #38
Baton Rouge, Louisiana, 70809
Bellus Health Investigational Site #23
Beverly Hills, California, 90212
Bellus Health Investigational Site #31
College Station, Texas, 77845
Bellus Health Investigational Site #45
Covington, Louisiana, 70433
Bellus Health Investigational Site #33
Encinitas, California, 92024
Bellus Health Investigational Site #27
Fountain Valley, California, 92708
Bellus Health Investigational Site #15
Hialeah, Florida, 33012
Bellus Health Investigational Site #14
High Point, North Carolina, 27262
Bellus Health Investigational Site #32
Margate, Florida, 33063
Bellus Health Investigational Site #16
Miami, Florida, 33125
Bellus Health Investigational Site #19
Miami, Florida, 33136
Bellus Health Investigational Site #36
Minneapolis, Minnesota, 55402
Bellus Health Investigational Site #18
New Orleans, Louisiana, 70115
Bellus Health Investigational Site #34
New York, New York, 10075
Bellus Health Investigational Site #37
Newtown Square, Pennsylvania, 19073
Bellus Health Investigational Site #29
Norman, Oklahoma, 73071
Bellus Health Investigational Site #13
Owensboro, Kentucky, 42301
Bellus Health Investigational Site #28
Phoenix, Arizona, 85032
Bellus Health Investigational Site #22
Portsmouth, New Hampshire, 03801
Bellus Health Investigational Site #41
Rapid City, South Dakota, 57702
Bellus Health Investigational Site #40
San Antonio, Texas, 78213
Bellus Health Investigational Site #11
San Antonio, Texas, 78229
Bellus Health Investigational Site #35
San Diego, California, 92123
Bellus Health Investigational Site #24
Savannah, Georgia, 31406
Bellus Health Investigational Site #10
Scottsdale, Arizona, 85254
Bellus Health Investigational Site #25
Seattle, Washington, 98101
Bellus Health Investigational Site #17
Sweetwater, Florida, 33172
Canada5 sites
Bellus Health Investigational Site #44
Chicoutimi, Quebec, G7H 7Y8
Bellus Health Investigational Site #20
Montreal, Quebec, H2X 2V1
Bellus Health Investigational Site #43
Québec, Quebec, G1N 4V3
Bellus Health Investigational Site #39
Québec, Quebec, G1W 4R4
Bellus Health Investigational Site #42
Sherbrooke, Quebec, J1L 0H8
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy, Safety, and Tolerability of BLU-5937 for the Treatment of Chronic Pruritus in Adult Subjects With Atopic Dermatitis
This is a multicenter, randomized, double-blind, placebo-controlled, parallel design study of BLU-5937 for the treatment of chronic pruritus in adult subjects with atopic dermatitis (AD).
Read the detailed description
The study will consist of a 37-day Screening period (including a 7-day Run-In period), a 4-week Treatment period followed by a Follow-Up visit approximately 2 weeks after the last dose of study drug.
- Conditions
- Chronic Pruritus, Atopic Dermatitis
- Being tested
- BLU-5937, Placebo
- Keywords
- BLU-5937, Chronic Pruritus, Atopic Dermatitis, P2X3 receptor antagonist
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLU-5937Drug
Oral administration of BLU-5937 tablets
PlaceboDrug
Oral administration of matching placebo for BLU-5937 tablets
| Study group | Role | What they receive |
|---|---|---|
| BLU-5937 oral tablet | Experimental | Eligible participants will receive BLU-5937 twice a day (BID) orally for 4 weeks. Receives: Drug: BLU-5937 |
| Placebo oral tablet | Placebo comparator | Eligible participants will receive matching Placebo BID orally for 4 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 mean Worst Itch Numeric Rating Scale (WI-NRS) score
Assessed by Worst Itch Numeric Rating Scale [WI-NRS]
The WI-NRS is a single item questionnaire assessing the patient-reported severity of itch at its most intense during the previous 24-hour period on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'the worst itch imaginable'. Higher scores indicate worse severity.
Measured: Week 4
Secondary outcomes (4)
Proportion of subjects achieving at least 4-point improvement from baseline in weekly mean Worst Itch Numeric Rating Scale (WI-NRS) score
Assessed by Worst Itch Numeric Rating Scale [WI-NRS]
The WI-NRS is a single item questionnaire assessing the patient-reported severity of itch at its most intense during the previous 24-hour period on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'the worst itch imaginable'. Higher scores indicate worse severity.
Measured: Week 4
Change from baseline in Average Itch Numeric Rating Scale (AI-NRS) score
Assessed by Average Itch Numeric Rating Scale [AI-NRS]
The AI-NRS is a single item questionnaire assessing the patient-reported severity of itch overall (on average) during the previous 24-hour period on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'the worst itch imaginable'. Higher scores indicate worse severity.
Measured: Week 4
Change from baseline in Itching Quality of Life Survey (ItchyQOL)
Assessed by Itching Quality of Life Survey [ItchyQOL]
The ItchyQOL is a 22-item questionnaire assessing the pruritus-specific disease burden on 3 domains: symptoms, functions and emotions. The responses to the frequency items are scored on a 1 (never) to 5 (all the time) scale. The recall period in ItchyQoL is the past week. Higher scores indicate a more adverse impact on quality of life.
Measured: Week 4
Proportion of subjects in each category of the Patient Global Impression of Change (PGIC) questionnaire
Assessed by Patient Global Impression of Change [PGIC]
The PGIC consists of 1 self-administered item that assesses the subject's impression of change in the severity of pruritus using a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher scores indicate a worsening of the severity.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start9 Dec 2020
- Primary completion4 Oct 2021
- Study completion12 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PruritusStudies of the same condition, open and under way.
- 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
- Model description
- Two-arm, parallel assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bellus Health Inc. - a GSK company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693195
- Sponsor's protocol ID
- CL-PR-5937-01
- Acronym
- BLUEPRINT
- Status last verified
- Oct 2022
- First submitted
- 30 Dec 2020
- Last updated
- 17 Oct 2022
- Results posted
- No
- 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 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy, Safety, and Tolerability of BLU-5937 for the Treatment of Chronic Pruritus in Adult Subjects With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT04693195
- Acronym / sponsor ID
- BLUEPRINT / CL-PR-5937-01
- Conditions
- Chronic Pruritus, Atopic Dermatitis
- Keywords
- BLU-5937, Chronic Pruritus, Atopic Dermatitis, P2X3 receptor antagonist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Bellus Health Inc. - a GSK companyIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 4 Oct 2021 (actual)
- Study completion
- 12 Oct 2021 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blind, placebo-controlled, parallel design study of BLU-5937 for the treatment of chronic pruritus in adult subjects with atopic dermatitis (AD).
Detailed description
The study will consist of a 37-day Screening period (including a 7-day Run-In period), a 4-week Treatment period followed by a Follow-Up visit approximately 2 weeks after the last dose of study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, parallel assignment
| Arm | Type | Receives |
|---|---|---|
| BLU-5937 oral tablet | Experimental | Drug: BLU-5937Eligible participants will receive BLU-5937 twice a day (BID) orally for 4 weeks. |
| Placebo oral tablet | Placebo comparator | Drug: PlaceboEligible participants will receive matching Placebo BID orally for 4 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)
- Willing to participate and is capable of giving informed consent
- Clinically confirmed diagnosis of active AD with at least a 6-month history of AD
- Chronic pruritus related to AD for at least 3 months
- Moderate to severe itch associated with mild to moderate AD
- Female of childbearing potential must agree to use a highly effective contraceptive method during the study and until at least 4 weeks after the last study drug administration
Key exclusion criteria (9 listed)
- History of skin disease or presence of skin condition that would interfere with the study assessments
- Clearly defined etiology for pruritus other than AD, including but not limited to: urticaria, psoriasis, or other non-atopic dermatologic conditions, hepatic or renal disease, psychogenic pruritus, drug reaction, uncontrolled hyperthyroidism, and infection
- Presence of any acute skin condition other than AD which may risk inducing a pruritus flare/worsening during the course of the study, including but not limited to: impetigo, active herpes simplex infection, or allergic contact dermatitis
- Subject is >65 years of age and has developed pruritus at age of ≥50 years
- History of cancer or lymphoproliferative disease within 5 years with the exception of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix
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 |
|---|---|---|
| BLU-5937Oral administration of BLU-5937 tablets | Drug | BLU-5937 oral tablet |
| PlaceboOral administration of matching placebo for BLU-5937 tablets | Drug | Placebo oral tablet |
Primary outcome
Change from baseline in weekly mean Worst Itch Numeric Rating Scale (WI-NRS) score
Time frame: Week 4
Assessed by Worst Itch Numeric Rating Scale [WI-NRS] The WI-NRS is a single item questionnaire assessing the patient-reported severity of itch at its most intense during the previous 24-hour period on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'the worst itch imaginable'. Higher scores indicate worse severity.
4 secondary outcomes
Proportion of subjects achieving at least 4-point improvement from baseline in weekly mean Worst Itch Numeric Rating Scale (WI-NRS) score
Time frame: Week 4
Change from baseline in Average Itch Numeric Rating Scale (AI-NRS) score
Time frame: Week 4
Change from baseline in Itching Quality of Life Survey (ItchyQOL)
Time frame: Week 4
Proportion of subjects in each category of the Patient Global Impression of Change (PGIC) questionnaire
Time frame: Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BLU-5937 in people with Chronic Pruritus and Atopic Dermatitis, run by Bellus Health Inc. - a GSK company at 33 sites in 2 countries.
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 9 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 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 mean Worst Itch Numeric Rating Scale (WI-NRS) score (time frame: Week 4). 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 17 Oct 2022.