UMIN-CTR Clinical Trial

Public title

Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Lecithinized Superoxide Dismutase Nebulizer (PC-SOD NE) in Adult Patients with Moderate Idiopathic Pulmonary Fibrosis

Acronym

Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Lecithinized Superoxide Dismutase Nebulizer (PC-SOD NE) in Adult Patients with Moderate Idiopathic Pulmonary Fibrosis

Scientific Title

Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Lecithinized Superoxide Dismutase Nebulizer (PC-SOD NE) in Adult Patients with Moderate Idiopathic Pulmonary Fibrosis

Scientific Title:Acronym

Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Lecithinized Superoxide Dismutase Nebulizer (PC-SOD NE) in Adult Patients with Moderate Idiopathic Pulmonary Fibrosis

Region

Japan

Asia(except Japan)

Condition

idiopathic pulmonary fibrosis

Classification by specialty

Pneumology

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the efficacy and safety of PC-SOD NE (daily dose, 20-mg/body) in a Phase 2 multi-center, double-blind, placebo-controlled study in patients with idiopathic pulmonary fibrosis (IPF)

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Change from baseline of forced vital capacity (FVC).

Key secondary outcomes

(1) FVC (rate of change), %FVC (change from baseline and rate of change), VC (change from baseline and rate of change), %VC (change from baseline and rate of change), total lung capacity (TLC) (change from baseline and rate of change), diffusing lung function (%DLco) (change from baseline and rate of change), SpO2 at rest (change from baseline and rate of change).
(2) Change from baseline and rate of change of pulmonary fibrosis markers.
(3) Activities of daily living (ADL).
(4) Acute exacerbations.
(5) Deterioration of FVC.
(6) Deterioration of SpO2.
(7) Survival rate: Overall survival rate and death from a respiratory cause.
(8) Progression free survival (PFS)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

YES

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

(PC-SOD NE 20-mg group)One vial containing 20-mg of PC-SOD NE, that is PC-SOD NE for inhalation via a nebulizer.
(Timing of administration)Study drug is administered in nebulized form once daily. (Administration period)Study drug is administered once daily for 26 weeks.

Interventions/Control_2

(Placebo group)One vial containing placebo.
(Timing of administration)Study drug is administered in nebulized form once daily. (Administration period)Study drug is administered once daily for 26 weeks.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1)Patients with IPF according to the guidelines and according to criteria established by the American Thoracic Society (ATS) 4 based on high-resolution computed tomography (HRCT) images.
(2)Patients with a percentage of predicted forced vital capacity (FVC) at screening of >60%.
(3)Patients with a percentage of predicted carbon monoxide diffusing capacity (DLco) at screening of >40%.
(4)Patients whose FVC levels were reduced by >=5% within 12 months prior to the screening point, except during its acute exacerbation.
(5)Sex: Male or female.
(6)Age: 20-80 years (when informed consent is received), both inclusive.
(7)Willing to use contraception: Female patients must be postmenopausal (for at least the past 12 months), surgically sterile, or have a negative urine pregnancy test at entry into the study. The patient must use maximally effective birth control during the course of the study, and be willing to use contraception for 6 months following the last study drug administration. Male patients must be either surgically sterile or willing to use a barrier contraception method upon enrollment, during the course of the study, and for 6 months following the last study drug administration.
(8)All patients must be able to read, understand, and provide written voluntary informed consent on the Institutional Review Board (IRB)/ Ethics Committee(EC) approved ICF and provide authorization as appropriate for local privacy regulations.
(9)Patients who are able and willing to comply with all treatment and follow-up procedures.

Key exclusion criteria

1) Exclusion criteria involving similar diseases
(1)Patients who's IPF was clearly caused by pharmaceuticals
(2)Patients diagnosed with asthma or chronic obstructive pulmonary disease (COPD) FEV1% <70% or Patients who are diagnosed with severe COPD from the HRCT image
(3)Patients diagnosed with a pulmonary or respiratory infection that may affect the efficacy of the study drug
2) Exclusion criteria due to previous treatment
(1)Patients who started to use steroids or changed the dose of the steroid within 4 weeks prior to the study drug administration.
(2)Patients who used immunosuppressants , pirfenidone, N-acetylcysteine or steroids within 4 weeks prior to study drug administration (on the other hand, those who stop these drugs for any reason and have a washout period of >=4 weeks can be enrolled).
3) Exclusion criteria due to potential safety issues
(1)Patients having Grade 4 hepatic, renal, or digestive disorders
(2)Patients who have complicated &#8805; Grade 4 hematologic disorders or cardiovascular diseases
(3)Patients who have complicated malignant neoplasm such as cancer or tumor occurring within 5 years before enrollment, however, patients with a history of lung cancer cannot enroll.
(4)Patients who are pregnant or possibly pregnant, or nursing
(5)Patients who participated in another clinical study within 4 months prior to the administration period of the study drug
(6)Patients who have a drug dependency or a history of drug abuse
(7)Patients who are current smokers
(8)Patients are sensitive to any drugs (all drugs prescribed or commercially available drugs) or have history of sensitivity to the drugs
(9)Patients who have taken PC-SOD or PC-SOD NE previously in their medical history
(10) Patients determined for other reasons not to be suitable to enter the current clinical study safely by the PI or subinvestigators.

Target sample size

96

Name of lead principal investigator

1st name
Middle name
Last name	Tohru Mizushima, Ph D

Organization

LTT Bio-Pharma Co., Ltd.

Division name

Chairman of the Board of Directors

Zip code

Address

Shiodome Building 3F, 1-2-20 Kaigan, Minato-ku, Tokyo 105-0022 Japan

TEL

03-5733-7391

Email

Name of contact person

1st name
Middle name
Last name	Tohru Mizushima, Ph D

Organization

LTT Bio-Pharma Co., Ltd.

Division name

Chairman of the Board of Directors

Zip code

Address

TEL

Homepage URL

http://www.ltt.co.jp/

Email

Institute

LTT Bio-Pharma Co., Ltd.

Institute

Department

Personal name

Organization

LTT Bio-Pharma Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

12

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2012

Year

03

Month

13

Day

Date of IRB

Anticipated trial start date

2012

Year

07

Month

18

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

12

Month

18

Day

Last modified on

2014

Year

07

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007993