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

• Register: EUCTR
• Last refreshed on: 12 December 2023
• Main ID: EUCTR2021-004787-10-PL
• Date of registration: 05/01/2022
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc.
• Public title: An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent Study
• Scientific title: AN OPEN LABEL, LONG-TERM EXTENSION STUDY TO INVESTIGATE THE SAFETY OF PF-06823859 ADMINISTERED TO ADULT PARTICIPANTS =18 AND =80 WITH ACTIVE DERMATOMYOSITIS.
• Date of first enrolment: 31/01/2022
• Target sample size: 20
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-004787-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Germany, Hungary, Italy, Poland, Spain, United States

Contacts

• Name: Clinical Trials.gov Call Centre
• Affiliation: Pfizer Inc.

• Name: Clinical Trials.gov Call Centre
• Affiliation: Pfizer Inc.

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Dermatomyositis
MedDRA version: 20.0 Level: PT Classification code 10012503 Term: Dermatomyositis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Intervention(s)

Product Name: PF-06823859
Product Code: PF-06823859
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PF-06823859
Current Sponsor code: PF-06823859
Other descriptive name: Humanised IgG1K monoclonal antibody against interferon beta
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Primary end point(s): Incidence of AEs, laboratory abnormalities, changes in vital signs, and ECG findings.

Secondary Objective: To evaluate the long-term efficacy of PF-06823859 in adult participants with moderate to severe DM.

Timepoint(s) of evaluation of this end point: Throughout the trial.

Main Objective: To evaluate the long-term safety and tolerability of PF-06823859.

Secondary Outcome(s)

Secondary end point(s): - Change from baseline in CDASI activity score at Week 52 for
participants who entered from Stage 2 of Protocol C0251002.
- Absolute values and changes from baseline of CDASI activity and CDASI damage scores at all scheduled timepoints.
- TIS score at Week 52 and at intermediate scheduled timepoints for participants who entered from Stage 3 of Protocol C0251002.
- Change from baseline in the CSMs of the TIS including PhGA, PtGA, MMT-8, HAQ-DI, muscle enzymes, and MDAAT at Week 52 and at intermediate scheduled timepoints.

Timepoint(s) of evaluation of this end point: Week 52 and all other scheduled timepoints.

Secondary ID(s)

C0251008

2021-004787-10-HU

Source(s) of Monetary Support

Pfizer Inc.

Ethics review

Status: Approved
Approval date: 15/12/2021
Contact: