Ignite Creation Date:
2024-05-06 @ 5:39 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05387707
Status:
TERMINATED
Last Update Posted:
2024-02-22
First Post:
2022-05-19
Brief Title:
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis
Sponsor:
Cara Therapeutics Inc
Organization:
Cara Therapeutics Inc
Study Overview
Official Title:
A Two-part Multicenter Randomized Double-blind Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate-to-Severe Pruritus in Adult Subjects With Atopic Dermatitis
Status:
TERMINATED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
In Part A of the study oral difelikefalin as adjunct to topical corticosteroids TCS did not demonstrate meaningful clinical benefit compared to TCS alone
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KIND-1
Brief Summary:
This is a two-part multicenter randomized double-blind study to evaluate the efficacy and safety of oral difelikefalin as adjunct therapy to a topical corticosteroid TCS for moderate-to-severe pruritus in adult subjects with atopic dermatitis AD
Detailed Description:
Part A of this study includes a 12-week Double-blind Treatment Period and a 52-week Open-label Extension Period Subjects will be randomized to receive oral difelikefalin 025 mg tablets BID plus TCS cream difelikefalin 05 mg tablets BID plus TCS cream placebo tablets BID plus TCS cream or placebo tablets BID plus vehicle cream
Part B of this study includes a 12-week Double-blind Treatment Period and 52-week Open-label Extension Period Subjects will be randomized to receive oral difelikefalin 025 mg or 05 mg tablets BID plus TCS cream or oral placebo tablets BID plus TCS cream Part A results at week 12 will inform Part B
Subjects who participated in Part A of the study may not participate in Part B
All subjects will sign an informed consent form ICF and undergo screening for study eligibility
Part B of this study includes a 12-week Double-blind Treatment Period and 52-week Open-label Extension Period Subjects will be randomized to receive oral difelikefalin 025 mg or 05 mg tablets BID plus TCS cream or oral placebo tablets BID plus TCS cream Part A results at week 12 will inform Part B
Subjects who participated in Part A of the study may not participate in Part B
All subjects will sign an informed consent form ICF and undergo screening for study eligibility
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None