A Phase 2, Safety, Tolerability, and Efficacy Study of PD 0360324 in Chronic Pulmonary Sarcoidosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01732211
• Date of registration: 19/11/2012
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: A Phase 2, Safety, Tolerability, and Efficacy Study of PD 0360324 in Chronic Pulmonary Sarcoidosis
• Scientific title: A PHASE 2 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, 20-WEEK SAFETY, TOLERABILITY, AND EFFICACY STUDY OF PD 0360324 IN ADULT SUBJECTS WITH CHRONIC PULMONARY SARCOIDOSIS
• Date of first enrolment: March 15, 2013
• Target sample size: 1
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01732211
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of biopsy-proved chronic pulmonary sarcoidosis either Stage 2 or Stage 3 for
at least 1 year;

- Forced Vital Capacity (FVC) lung assessment of >40% and < or = to 80% predicted normal
values at screening;

- age 21-75 years of age;

- treatment with a stable (longer than 4 weeks) regimen of corticosteroids (between 10
and 30 mg of prednisone) for at least 3 months prior to Screening; (other
anti-inflammatory drugs may be permitted as defined by the study protocol)

Exclusion Criteria:

- History of any other pulmonary (lung) disease than sarcoidosis (ex, asthma requiring
maintenance treatment, chronic obstructive pulmonary disease (COPD));

- Pulmonary hypertension, significant lung fibrosis, any chronic infection (eg, TB,
HIV);

- treatment with other biologic anti-inflammatory/immuno-modulatory drugs;

- active smokers;

- class 3 or 4 congestive heart failure;

- cancer, or history of cancer within past 5 years;

- history of ischemic heart disease, heart attack, stroke, any heart muscle disease;

- liver disease;

- history of alcohol or drug abuse



Age minimum: 21 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Sarcoidosis

Intervention(s)

Other: Normal Saline for injection

Biological: PD 0360324

Primary Outcome(s)

Change From Baseline (Absolute) in % Predicted Forced Vital Capacity (FVC) Compared to Placebo at Week 16 [Time Frame: Baseline, Week 16]

Secondary Outcome(s)

Estimated Treatment Effect Over Placebo in FVC Averaged Over 16 Weeks [Time Frame: Baseline, Weeks 0, 2, 4, 8, 12, 14, 16]

Change From Baseline in Chest X-ray Global Assessment Score (5-point ) [Time Frame: Baseline, Week 16]

Change From Baseline in % Predicted FEV1 at Weeks 2,4,8,12,14, 16 and 20 [Time Frame: Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20]

Change From Baseline Absolute in FVC (% Predicted) Compared to Placebo at Weeks 2,4,8,12,14, and 20 [Time Frame: Baseline, Weeks 2, 4, 8, 12, 14, and 20]

Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2,4,8,12,14, 16 and 20 [Time Frame: Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20]

Change From Baseline in FVC (Absolute ) Compared to Placebo at Weeks 2,4,8,12, 14, and 20 [Time Frame: Baseline, Weeks 2, 4, 8, 12, 14, and 20]

Change From Baseline in Ratio of FEV1/FVC at Weeks 2,4,8,12,14, 16 and 20 [Time Frame: Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20]

Secondary ID(s)

A6261009

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/01/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01732211