Ignite Creation Date:
2024-05-06 @ 6:29 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05680818
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2022-12-12
Brief Title:
Efficacy and Safety of Encaleret Compared to Standard of Care in Participants With ADH1
Sponsor:
Calcilytix Therapeutics Inc a BridgeBio company
Organization:
Calcilytix Therapeutics Inc a BridgeBio company
Study Overview
Official Title:
CALIBRATE A Phase 3 Randomized Open-Label Study Evaluating the Efficacy and Safety of Encaleret Compared to Standard of Care in Participants With Autosomal Dominant Hypocalcemia Type 1 ADH1
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CALIBRATE
Brief Summary:
The primary purpose of the study is to understand the effectiveness safety and tolerability of encaleret when compared to standard of care SoC treatment in participants with Autosomal Dominant Hypocalcemia Type 1 ADH1
Detailed Description:
ADH1 is a rare genetic form of hypoparathyroidism ADH1 may be passed down from affected parents to their children
The main portion of the study is divided into a Screening Period and 3 Periods followed by an optional Long-Term Extension LTE The estimated duration of this main portion of the study is approximately 12 months The duration of the LTE is approximately 48 months
Participants will enter an up-to-6-week Screening period and once confirmation of all InclusionExclusion criteria transition into an up-to-15-week standard of care SoC optimization phase The eligible participants will enter Period 1 after completing the SoC optimization phase
Period 1 is the 4-week SoC Maintenance period of the study during which the SoC dose will only be adjusted to address potential safety concerns such as hypocalcemia or hypercalcemia
After completion of Period 1 eligible participants will enter Period 2 and will be randomized to receive either encaleret or SoC treatment for 20 weeks Both the investigator and participant will know whether the participant was randomized to the encaleret treatment arm or SoC treatment arm During Period 2 encaleret or SoC will be adjusted based on blood calcium levels
After completion of Period 2 participants will proceed to Period 3 the 4-week dose maintenance period
Following completion of Period 3 participants from CLTX-305-302 may enter the LTE Those who completed CLTX-305-201 NCT04581629 are also eligible to continue in the LTE Participants will receive encaleret treatment for approximately 48 months or 72 months for participants who transitioned from CLTX-305-201 or until a participant has access to commercial encaleret or the Sponsor decides to end the study whichever occurs first
The main portion of the study is divided into a Screening Period and 3 Periods followed by an optional Long-Term Extension LTE The estimated duration of this main portion of the study is approximately 12 months The duration of the LTE is approximately 48 months
Participants will enter an up-to-6-week Screening period and once confirmation of all InclusionExclusion criteria transition into an up-to-15-week standard of care SoC optimization phase The eligible participants will enter Period 1 after completing the SoC optimization phase
Period 1 is the 4-week SoC Maintenance period of the study during which the SoC dose will only be adjusted to address potential safety concerns such as hypocalcemia or hypercalcemia
After completion of Period 1 eligible participants will enter Period 2 and will be randomized to receive either encaleret or SoC treatment for 20 weeks Both the investigator and participant will know whether the participant was randomized to the encaleret treatment arm or SoC treatment arm During Period 2 encaleret or SoC will be adjusted based on blood calcium levels
After completion of Period 2 participants will proceed to Period 3 the 4-week dose maintenance period
Following completion of Period 3 participants from CLTX-305-302 may enter the LTE Those who completed CLTX-305-201 NCT04581629 are also eligible to continue in the LTE Participants will receive encaleret treatment for approximately 48 months or 72 months for participants who transitioned from CLTX-305-201 or until a participant has access to commercial encaleret or the Sponsor decides to end the study whichever occurs first
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