NCT03324503

Brief Summary

This is a multicenter, single-arm, unblinded/open-label study of the effect size of HRCT endpoints in response to glucocorticoid induction therapy in subjects with a diagnosis of pulmonary sarcoidosis who have not received glucocorticoid as initial sarcoidosis therapy (≥ 20 mg/day prednisone or prednisolone) or other sarcoidosis therapy for at least 3 months prior to enrollment. This study will enroll a total of approximately 24 subjects.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
3 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 27, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

December 8, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2019

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

Enrollment Period

1.9 years

First QC Date

October 12, 2017

Last Update Submit

February 25, 2020

Conditions

Sarcoidosis, Pulmonary

Keywords

Pulmonary SarcoidosisHRCTGlucocorticoidPrednisoneFRIPrednisolone

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in high-resolution computed tomography (HRCT)

    Is defined as measurements of lobar volumes total lung capacity (TLC) in response to glucocorticoid induction therapy in subjects with pulmonary sarcoidosis.

    Up to approximately 8 weeks

Study Arms (1)

Glucocorticoid ≥ 30 mg/day

EXPERIMENTAL

≥ 30 mg/day prednisone or prednisolone as per local clinical practice of sarcoidosis initial induction therapy will be taken orally preferably before, during, or immediately after meals or with food or milk, at approximately the same time of day for 8 weeks.

Drug: Glucocorticoid (prednisone or prednisolone)

Interventions

Glucocorticoid (prednisone or prednisolone)DRUG

≥ 30 mg/day prednisone or prednisolone taken orally as per local clinical practice of sarcoidosis initial induction therapy

Also known as: prednisone or prednisolone
Glucocorticoid ≥ 30 mg/day

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must satisfy the following criteria to be enrolled in the study:
  • Subject are male or female ≥ 18 and ≤ 65 years of age, inclusive, at the time of signing the informed consent form (ICF).
  • Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
  • Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
  • Subject has not received glucocorticoid as initial sarcoidosis therapy (≥ 20 mg/day prednisone or prednisolone) or other sarcoidosis therapy for at least 3 months or 5 PK half-lives, whichever is longer, prior to enrollment.
  • Subjects have a diagnosis of pulmonary sarcoidosis:
  • According to the American Thoracic Society/European Respiratory Society/World Association of Sarcoidosis and other Granulomatous Disorders (ATS/ERS/WASOG) statement, supported by clinical presentation and biopsy-proven noncaseating granulomatous inflammation with no alternative cause of the granulomas;
  • With radiographic stage II or III disease;
  • With dyspnea (MRC grade ≥ 1);
  • With an FVC of ≥ 45% and ≤ 80% of predicted normal value at screening;
  • With or without concurrent extra-pulmonary sarcoidosis;
  • Without clinically significant neurosarcoidosis or cardiac sarcoidosis;
  • Without history of resistance or refractoriness to glucocorticoid induction therapy.
  • Subject is in good health (except for sarcoidosis) as determined by a physical examination at screening.
  • a. Stable and mild syndromes associated with normal ageing, that are not expected to affect safe participation or data interpretation are allowed. Examples include, but are not limited to, systemic hypertension, hypothyroidism, prostatic hypertrophy, etc.
  • +10 more criteria

You may not qualify if:

  • The presence of any of the following will exclude a subject from enrollment. If the result(s) do not satisfy eligibility criteria, subjects will be ineligible to enroll in the study and will be considered a screen failure. Subjects may be re-screened with the approval of the medical monitor:
  • Subject has any significant medical condition, laboratory abnormality, neurological disease or psychiatric illness that would prevent the subject from safely completing the study. Prior evidence of neurological disease must be documented.
  • Subject has any condition that confounds the ability to interpret data from the study.
  • Subject is a pregnant or a nursing female.
  • Subject has received another interventional investigational drug for sarcoidosis within the 3 months prior to screening or 5 PK half-lives, whichever is longer\*.
  • Subject has clinically significant lung disease, other than sarcoidosis, such as asthma, chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD) or lung cancer.
  • a. Subject has a history of significant (greater than a wedge) lung resection.
  • Subject is receiving therapy for sarcoidosis associated pulmonary hypertension, or has an indication for such therapy.
  • Subject has uncontrolled diabetes and other contraindications to glucocorticoid therapy.
  • Subject has a history of listeriosis, coccidioidomycosis, histoplasmosis, blastomycosis, treated or untreated tuberculosis or exposure to individuals with tuberculosis.
  • Subject is an active smoker or has \> 10 pack-year smoking history. Previous smokers must have discontinued smoking for at least 1 year.
  • Subject is unable to perform any study-related procedure or maneuver.
  • Subject has had any biologic anti-tumor necrosis factor (anti-TNF) therapy within the previous year.
  • Subject has active infection requiring treatment within 30 days prior to screening\*.
  • Subject has a positive QuantiFERON-TB Gold tuberculosis test.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

University of Alabama Birmingham

Birmingham, Alabama, 35233, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Johns Hopkins University School of Medicine - Baltimore

Baltimore, Maryland, 21287, United States

Location

Pulmonary and Critical Care Medicine-Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

PMG Research of Wilmington, LLC

Wilmington, North Carolina, 28401, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

Location

Cleveland Clinic - Taussig Cancer Institute

Cleveland, Ohio, 44195, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MultiCare Institute for Research and Innovation

Tacoma, Washington, 98405, United States

Location

Catharina Ziekenhuis

Eindhoven, 5602, Netherlands

Location

Erasmus University Medical Center

Rotterdam, 3015 CE, Netherlands

Location

Onderzoekscentrum longziekten Zutphen

Zutphen, 7207 AE, Netherlands

Location

University College London Hospitals NHS Foundation Trust - University College Hospital

London, NW1 2BU, United Kingdom

Location

Richmond Pharmacology

London, SE1 1YR, United Kingdom

Location

Imperial College London - Hammersmith Hospital Campus

London, W12 0NN, United Kingdom

Location

University Hospital of South Manchester NHS Foundation Trust -Wythenshawe Hospital - North West Lung

Manchester, M23 9LT, United Kingdom

Location

Oxford University Hospitals NHS Trust- Churchill Hospital-Oxford Centre for Respiratory Medicine

Oxford, 0X3 7LE, United Kingdom

Location

Southmead Hospital

Westbury-on-Trym/ Bristol, BS10 5NB, United Kingdom

Location

The Royal Wolverhampton Hospitals NHS Trust - Newcross Hospital

Wolverhampton, WV10 0QP, United Kingdom

Location

MeSH Terms

Conditions

Sarcoidosis, Pulmonary

Interventions

GlucocorticoidsPrednisonePrednisolone

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesSarcoidosisLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Adrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnadienetriols

Study Officials

  • Gopal Krishna, PhD

    Celgene

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2017

First Posted

October 27, 2017

Study Start

December 8, 2017

Primary Completion

November 15, 2019

Study Completion

November 15, 2019

Last Updated

February 26, 2020

Record last verified: 2020-02

Locations

GB(7)US(10)NL(3)