An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent Study

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

1. Participants aged =18 and =80 with moderate to severe DM, that have completed the treatment period of the qualifying study.
2. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
3. Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.
4. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

Medical Conditions:
1. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
Prior/Concomitant Therapy:
2. Current use of any prohibited concomitant medication(s) listed in Appendix 8.
3. Hematologic abnormalities defined as:
ANC =1000/mm3;
Platelets =25,000/mm3;
Hemoglobin =8g/dL.
4. Hepatic dysfunction defined as:
Total bilirubin =2x ULN (=3x ULN for Gilbert’s disease);
AST =2.5 x ULN;
ALT =2.5 x ULN;
For Participants with DM who experience elevated AST, ALT, LDH, aldolase, and CK, due to muscle involvement the investigator should determine whether or not these are related to the existing condition of DM or if these lab abnormalities are related to another condition. Information should
be provided in the source documentation with rationale related to any lab abnormalities.
5. Baseline standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF interval >450 msec, complete LBBB, signs of an acute or indeterminate age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second or third degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is >450 msec, this interval should be rate corrected using the Fridericia method and the resulting QTcF should be used for decision making and
reporting. If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTcF or QRS values should be used to determine the participant’s eligibility. Computer interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding a participant.
6. Participants who met discontinuation criteria at any point during the participating qualifying studies.
7. Participants with an ongoing safety event in the qualifying studies which, in the opinion of the investigator or sponsor, is an ongoing safety concern OR the participant has met safety monitoring criteria in the qualifying study that has not resolved.
8. Participants with significant protocol deviations (eg, not following the protocol, not using appropriate contraception) or have had a serious adverse event related to study drug in the previous qualifying studies.
Other Exclusions:
9. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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