A Multiple-Dose Study of BLU-5937 in Chronic Pruritus Associated With Atopic Dermatitis (BLUEPRINT)
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| ClinicalTrials.gov Identifier: NCT04693195 |
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Recruitment Status :
Completed
First Posted : January 5, 2021
Last Update Posted : December 1, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Pruritus Atopic Dermatitis | Drug: BLU-5937 Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 142 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Two-arm, parallel assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | December 9, 2020 |
| Actual Primary Completion Date : | October 4, 2021 |
| Actual Study Completion Date : | October 12, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: BLU-5937 oral tablet
Eligible participants will receive BLU-5937 BID orally for 4 weeks.
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Drug: BLU-5937
Oral administration of BLU-5937 tablets |
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Placebo Comparator: Placebo oral tablet
Eligible participants will receive matching Placebo BID orally for 4 weeks.
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Drug: Placebo
Oral administration of matching placebo for BLU-5937 tablets |
- 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.
- 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 ]
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.
- Change from baseline in Average Itch Numeric Rating Scale (AI-NRS) score [ Time Frame: Week 4 ]
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.
- Change from baseline in Itching Quality of Life Survey (ItchyQOL) [ Time Frame: Week 4 ]
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.
- Proportion of subjects in each category of the Patient Global Impression of Change (PGIC) questionnaire [ Time Frame: Week 4 ]
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04693195
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| Responsible Party: | Bellus Health Inc |
| ClinicalTrials.gov Identifier: | NCT04693195 |
| Other Study ID Numbers: |
CL-PR-5937-01 |
| First Posted: | January 5, 2021 Key Record Dates |
| Last Update Posted: | December 1, 2021 |
| Last Verified: | November 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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BLU-5937 Chronic Pruritus Atopic Dermatitis P2X3 receptor antagonist |
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Dermatitis, Atopic Dermatitis Eczema Pruritus Skin Diseases Skin Diseases, Genetic |
Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Skin Manifestations |