SUN11031 in Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD)

NCT00698828 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ASBI 307
• Study Type: interventional
• Target: 227
• Locations: 6 countries
• Sites: 43

Brief Summary

To evaluate SUN11031 for subcutaneous injection compared to placebo in subjects with cachexia associated with Chronic Obstructive Pulmonary Disease (COPD) to determine the effect on physical performance and body composition.

Conditions

Cachexia

Keywords

Cachexia, COPD, Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline to Day 85 in the Distance Walked During the 6 Minute Walk Test (MWT) Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD)

  Assessment of functional capacity in study participants with chronic obstructive pulmonary disease (COPD) via the 6-minute walk test (6MWT) provided an objective measure of disability. The 6MWT is a practical and objective evaluation of functional exercise capacity. The test measures the distance that a participant can quickly walk on a flat, hard surface in 6 minutes. In order to ensure uniformity among the sites, the specifications of the course for the 6MWT were modified from being 30 meters long with 60-meter laps to be 15 meters long with 30-meter laps to accommodate space limitations encountered at select sites.

  Baseline up to Day 85 post dose.

Secondary Outcomes (8)

• Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD)

  Baseline up to Day 29, Day 57, and Day 85 post dose.

• Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD)

  Baseline up to Day 29, Day 57, and Day 85 post dose.

• Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease

  Baseline up to Day 85 post dose.

• Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease

  Baseline up to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85, and Day 99 post dose.

• Mean Change in Lean Body Mass From Baseline Through Days 29, 85 and 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease

  Baseline up to Day 29, Day 85, and Day 99 post dose.

Study Arms (3)

Group 1

EXPERIMENTAL

SUN11031 for injection, low dose, twice daily for 12 weeks

Drug: SUN11031 20 μg/kg

Group 2

EXPERIMENTAL

SUN11031 for injection, higher dose, twice daily for 12 weeks

Drug: SUN11031 40 μg/kg

Group 3

PLACEBO COMPARATOR

Placebo injection, twice daily for 12 weeks

Drug: Placebo comparator

Interventions

Placebo comparator DRUG

Twice daily subcutaneous injections of placebo for 12 weeks.

Group 3

SUN11031 20 μg/kg DRUG

Twice daily subcutaneous injections of SUN11031 20 μg/kg for 12 weeks.

Group 1

SUN11031 40 μg/kg DRUG

Twice daily subcutaneous injections of SUN11031 40 μg/kg for 12 weeks.

Group 2

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Each participant had to meet the following criteria to be enrolled in the study:
• Male or non-pregnant female participants 50 years or older with a clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD) for greater than or equal to 12 months
• Walked a distance of greater than or equal to 100 but less than or equal to 450 meters during the 6-Minute Walk Test (MWT) performed at screening.
• Chest x-ray within the past year that was compatible with COPD
• Documented involuntary nonedematous weight loss of greater than 5% of participant's usual body weight over the past 12 months or BMI less than or equal to 21 kg/m\^2 for males or Body Mass Index (BMI) less than or equal to 20 kg/m\^2 for females
• Female participants who were clinically sterile (eg, either postmenopausal or had undergone a tubal ligation or hysterectomy) or were practicing a medically acceptable method of birth control (eg, oral, transdermal, implantable, or injectable contraceptive medications; double-barrier method or intrauterine device)

You may not qualify if:

• Participants who met any of the following criteria were excluded from the study:
• BMI greater than 26 kg/m\^2
• Used, over a total of 7 or more days, parenteral corticosteroids at a dose equivalent to prednisone at greater than or equal to 5 mg/day or oral corticosteroids at a dose equivalent to prednisone at greater than 10 mg/day within the 2 months before screening; however, participants were allowed to participate if on stable doses equivalent to prednisone at less than or equal to 10 mg/day for at least 2 months before screening, and were planning to remain on the same stable dose throughout the study
• Were planning to start a pulmonary rehabilitation program during the study (participant may have been enrolled in the study if he or she was currently on a stable maintenance program)
• Weight loss that was considered to be, in the opinion of the investigator, the result of food deprivation
• Unintended weight loss that may have been due to disease other than COPD
• Unable or unwilling to be trained to self-administer the study drug by subcutaneous injection bid, and for whom arrangements could not be made for a third party to reliably administer the injections
• Severe anemia (hemoglobin less than or equal to 8 g/dL)
• COPD exacerbation defined as a Type 1 or 2 exacerbation according to the Winnipeg criteria, acute infection, or prolonged fever within 4 weeks before screening
• Undergoing treatment or evaluation for cancer, or had a history of treatment for cancer within the past 3 years, exception being nonmelanoma skin cancer (basal cell or squamous cell carcinoma of the skin) and carcinoma in situ of the cervix
• Type I or type II diabetes mellitus or a fasting serum glucose of greater than or equal to 115 mg/dL (6.4 mmol/L) (fasting was overnight)
• Serious disease or conditions that would have interfered with the participant's ability to complete the functional measures included in this protocol; or any illness that, in the opinion of the investigator, might have interfered with the results of the study or the participant's ability to participate
• Pulmonary embolism, deep venous thrombosis, or clinically significant primary pulmonary hypertension within the past 6 months
• Significant ischemic heart disease or chronic heart failure (New York Heart Association Class IV cardiac disease)
• Uncontrolled hypertension (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 110 mm Hg)

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (43)

Waterbury Pulmonary Associates

Waterbury, Connecticut, 06708, United States

Location

Clinical Research of West Florida

Clearwater, Florida, 33765, United States

Location

Innovative Research of West Florida

Largo, Florida, 33756, United States

Location

The Center for Clinical Research, Washington County Hospital

Hagerstown, Maryland, 21740, United States

Location

Montana Medical Research, Inc.

Missoula, Montana, 59808, United States

Location

The Asthma & Allergy Center

Papillion, Nebraska, 68046, United States

Location

Health Science Research Center - Asthma & Allergy Associates

Cortland, New York, 13045, United States

Location

New Horizons Clinical Research

Cincinnati, Ohio, 45252, United States

Location

Clinical Research Institute of Southern Oregon

Medford, Oregon, 97504, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Pulmonary Consultants

Tacoma, Washington, 98405, United States

Location

Centro de Investigaciones Médicas

Florencío Varela, Buenos Aires, Argentina

Location

Instituto de Investigaciones Clinicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Location

Centro Respiratorio Quilmes

Quilmes, Buenos Aires, B1878FNR, Argentina

Location

Instituto de Investigaciones Clínicas Cipolletti

Cipolletti, Río Negro Province, R8324EMD, Argentina

Location

Clinica del Tórax

Rosario, Santa Fe Province, S2000DBS, Argentina

Location

Instituto Cardiovascular de Rosario

Rosario, Santa Fe Province, S2000DSV, Argentina

Location

CEMIT

San Miguel de Tucumán, Tucumán Province, Argentina

Location

Centro de Investigación Médica Lanús

Buenos Aires, Argentina

Location

FAICEP

Capital Federal, C1122AAK, Argentina

Location

Instituto Médico de Asistencia e Investigación

Capital Federal, C1425AWC, Argentina

Location

Centro Médico Dra. De Salvo

Capital Federal, C1426ABP, Argentina

Location

Centro Médico Belgrano

Capital Federal, C1429BNQ, Argentina

Location

Centro Ceri

Capital Federal, Argentina

Location

Centro de Estudios Neumonologicos

Capital Federal, Argentina

Location

Fuesmen

Mendoza, cp 5500, Argentina

Location

Instituto de Enfermedades Respiratorias

Mendoza, Argentina

Location

Centro de Medicina Respiratoria

Paraná, Argentina

Location

Instituto de Patologia Respiratoria

San Miguel de Tucumán, Argentina

Location

Hospital Barros Luco Trudeau

Santiago, Chile

Location

Hospital San Jose

Santiago, Chile

Location

Integramedica La Florida

Santiago, Chile

Location

Instituto Pneos

Guatemala City, 01010, Guatemala

Location

Edificio Centro Medico II

Guatemala City, Guatemala

Location

Private Clinic

Guatemala City, Guatemala

Location

Edificio Medico San Lucas

Quetzaltenango, Guatemala

Location

Centro de Neumologia y Alergia

San Pedro Sula, Honduras

Location

Instituto Nacional Cardiopulmonar

Tegucigalpa, Honduras

Location

Spitalul Clinic de Pneumoftiziologie "Leon Daniello" Cluj-Napoca

Cluj-Napoca, Cluj, 400371, Romania

Location

Spitalul Clinic de Boli Infectioase si Pneumoftiziologoe "Dr. Victor Babes"

Timișoara, Timiș County, 300310, Romania

Location

Spitalul Clinic de Pneumoftiziologie "Leon Daniello" Cluj-Napoca

Cluj-Napoca, 400371, Romania

Location

Spitalul Clinic de Pneumoftiziologie Constanta, Cartier Palazul Mare

Constanța, 900002, Romania

Location

Spitalul Clinic Judetean Sibiu, Clinica Medicala

Sibiu, 550245, Romania

Location

Related Links

• Related Info

MeSH Terms

Conditions

Cachexia; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Results Point of Contact

• Title: Contact for Clinical Trial Information
• Organization: Daiichi Sankyo

CTRinfo@dsi.com

908-992-6400

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2008
• First Posted: June 17, 2008
• Study Start: May 15, 2008
• Primary Completion: October 8, 2009
• Study Completion: October 8, 2009
• Last Updated: January 28, 2021
• Results First Posted: January 28, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

GU (4); US (11); HO (2); AR (18); CL (3); RO (5)