A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus Erythematosus



Sponsors

Lead Sponsor



Source

Celgene

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

Yes

Is Fda Regulated Device

No


Brief Summary

The purpose of this Phase 2, multicenter, randomized, placebo-controlled, double-blind study
to evaluate the efficacy and safety of an oral treatment regimen of CC-220 versus placebo in
adult subjects with active systemic lupus erythematosus.

Approximately 280 subjects with a documented diagnosis of SLE will be randomized 2:2:1:2 to
receive CC-220 (0.45 mg QD, 0.3 mg QD or 0.15 mg QD) or identically appearing placebo.

Detailed Description

The study consists of four phases:

- 4-week Screening Phase

- 24-week placebo-controlled phase Subjects will receive either 0.45 mg QD, 0.3 mg QD,
0.15 mg QD or placebo for the first 24 weeks of treatment.

- 28-week active treatment phase At Week 24, all subjects on placebo will be re-randomized
to active treatment.

- 4-week observational follow-up All subjects who complete 52 weeks of treatment or
discontinue the study early will enter a post-treatment observation follow-up phase.

Overall Status

Recruiting

Start Date

2017-07-06

Completion Date

2020-02-11

Primary Completion Date

2019-12-20

Phase

Phase 2

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Proportion of subjects who achieve SRI(4) response- Week 24
Week 24

Secondary Outcome

Measure

Time Frame

Proportion of subjects who achieve SRI(4) response - Week 52
Week 52
Proportion of subjects with SLEDAI 2K score improvement of ≥ 4 points from Baseline
Weeks 24 and 52
Proportion of subjects with a ≥ 50% reduction in Cutaneous Lupus Area and Severity Index (CLASI) activity score from baseline, in subjects with Baseline CLASI activity score ≥ 10
Weeks 24 and 52
Proportion of subjects with no new organ system affected as defined by 1 or more BILAG A or new 2 or more BILAG B items compared to Baseline using BILAG 2004 Index
Weeks 24 and 52
Percentage of subjects with no worsening (increase of <0.30 points from Baseline) in Physician's Global Assessment (PGA) compared to Baseline
Week 24
Mean change from Baseline in swollen joint count in subjects with ≥ 3 swollen joints at Baseline
Week 24 and 52
Mean change from Baseline in tender joint count in subjects with ≥ 3 tender joints at Baseline
Week 24 and 52
Mean change from Baseline in PGA score
Week 24 and 52
Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score
Week 24 and 52
Major clinical response defined as BILAG C or better in all organ domains at Week 24 with maintenance of this response through Week 52
Week 24 and 52
Corticosteroid Reduction- Week 24
Week 24
Corticosteroid Reduction- Week 52
Week 52
Area under the curve (AUC) of SLE flare as defined by the SLE Flare Index
Up to 52 weeks
Percentage of subjects experiencing a SLE flare as defined by the SLE Flare Index
Up to 52 weeks
: Time to flare as defined by the SLE Flare Index
Up to 52 weeks
Change from Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index
52 weeks

Enrollment

280

Condition


Intervention

Intervention Type

Drug

Intervention Name


Description

0.45 mg QD PO

Arm Group Label

CC-220 0.45 mg QD Placebo Controlled Phase


Intervention Type

Drug

Intervention Name


Description

0.3 mg QD PO

Arm Group Label

C-220 0.3 mg QD Placebo Controlled Phase


Intervention Type

Drug

Intervention Name


Description

0.15 mg QD PO

Arm Group Label

CC-220 0.15 mg QD Placebo Controlled Phase


Intervention Type

Other

Intervention Name


Description

Placebo QD PO

Arm Group Label

CC-220 0.45 mg QD Placebo Controlled Phase

C-220 0.3 mg QD Placebo Controlled Phase

CC-220 0.15 mg QD Placebo Controlled Phase

Placebo




Eligibility

Criteria

Inclusion Criteria:

1. Male or female 18 years of age or older at the time of signing the informed consent.

2. Able and willing to adhere to the visit schedule and other protocol requirements.

3. Have a diagnosis of SLE for at least 6 months prior to the Screening Visit and fulfill
the 1997 update of the 1982 American College of Rheumatology (ACR) Classification
Criteria for SLE at the Screening Visit.

4. At the Screening Visit a Systemic Lupus Erythematosus Disease Activity Index (2K)
(SLEDAI 2K) score of ≥ 6 points, at least four points of which are a "clinical" SLEDAI
2K score. The "clinical" score is the SLEDAI 2K assessment score without the inclusion
of points attributable to any urine or blood laboratory results including immunologic
measures. Neurologic descriptors of the SLEDAI 2K are not counted towards the SLEDAI
study entry criteria.

5. At the Baseline Visit, a clinical SLEDAI 2K score of ≥ 4 points.

Positive antibodies associated with SLE, which must include at least one of the
following within the Screening Phase:

- Positive antinuclear antibody (ANA) test at the central laboratory with a titer
of 1:80 or greater, associated with a diagnosis of SLE, Anti-dsDNA antibodies
elevated to above normal as per the central laboratory,

- Anti-Smith (anti-Sm) antibody elevated to above normal as per the central
laboratory.

6. Females of childbearing potential (FCBP) must:

- Have two negative pregnancy tests as verified by the investigator prior to
starting study therapy, one within 10 to 14 days prior to the first dose of
CC-220 and again within 24 hours before taking the first dose of CC-220. She must
agree to ongoing pregnancy testing during the course of the study, and after end
of study treatment. This applies even if the subject practices true abstinence
from heterosexual contact.

- Either commit to true abstinence2 from heterosexual contact (which must be
reviewed on a monthly basis and source documented) or agree to use two forms of
reliable contraception simultaneously. One must be a highly effective method and
one additional effective (barrier) method, and both must be practiced without
interruption, 28 days prior to starting investigational product, during the study
therapy (including dose interruptions), and for 28 days after discontinuation of
study therapy.

- Male subjects must: Practice true abstinence or agree to use a barrier
contraception (male latex condom or non-latex condom NOT made out of natural
[animal] membrane [for example, polyurethane]) during sexual contact with a
pregnant female or a female of childbearing potential while participating in the
study, during dose interruptions and for at least 90 days following
investigational product discontinuation, even if he has undergone a successful
vasectomy.

- Male subjects must agree not to donate semen or sperm during therapy and for at
least 90 days following the discontinuation of Investigational Product (IP).

7. All subjects must:

- Understand that the IP could have potential teratogenic risk.

- Agree to abstain from donating blood while taking IP and for 28 days following
discontinuation of the IP.

- Agree not to share IP with another person.

- Other than the subject, FCBP and males able to father a child should not handle
the IP or touch the capsules unless gloves are worn.

- Be counseled about pregnancy precautions and risks of fetal exposure as described
in the Pregnancy Prevention Plan.

8. If taking oral corticosteroids, must be on for at least 4 weeks prior to the Screening
Visit, and maintained on a stable dose of ≤ 20 mg/d of prednisone or equivalent for at
least 2 weeks prior to the Baseline Visit.

9. If taking SLE standard of care treatment (e.g. anti-malarial, mycophenolate mofetil,
azathioprine) for 12 weeks prior to and be on a stable dose for at least 4 weeks prior
to Baseline.

Exclusion Criteria:

1. Must be off prohibited medications for a pre-specified period of time.

2. Received intra-articular, intralesional, subcutaneous, intradermal, intramuscular or
IV pulse corticosteroids 6 weeks prior to the Baseline Visit.

3. Received an investigational product within 5 pharmacokinetic half-lives or one month,
whichever is longer, prior to the Baseline Visit.

4. Severe lupus nephritis defined as: estimated glomerular filtration rate (eGFR) of < 45
mL/1.73 m2 or proteinuria > 2000 mg/day if stable for the past 3 months or proteinuria
> 500 mg/day if unstable.

5. Proteinuria will be based upon spot urine testing.

6. Active, severe or unstable neuropsychiatric lupus disease within 6 months of the
Screening Visit.

7. History or confirmed positive test for hepatitis B History of congenital and/or
acquired mmunodeficiencies (eg, common variable immunodeficiency, human
immunodeficiency virus [HIV], etc).

8. Active or history of recurrent bacterial, viral, fungal, mycobacterial or other
infections, or any major episode of infection requiring hospitalization or treatment
with intravenous or oral antibiotics within 4 weeks of the Screening Visit and at any
time during the Screening Phase, up through the first dose of IP.

9. Active tuberculosis (TB) or a history of incompletely treated TB, or a positive,
QuantiFERON®-TB Gold test.

10. Malignancy or history of malignancy, except for:

- treated (eg, cured) basal cell or squamous cell in situ skin carcinomas

- treated (eg, cured) cervical intraepithelial neoplasia or carcinoma in situ of
the cervix with no evidence of recurrence within 5 years of the Screening Visit.

11. Diagnosis of Antiphospholipid Syndrome History of arterial or venous thrombosis within
one year of the Screening Visit.

12. History or current diagnosis of peripheral neuropathy (sensory or motor) ≥ Grade 2.

13. Presence of active uveitis or any other ophthalmological finding that in the opinion
of the Investigator is clinically significant.

14. Other non-SLE driven inflammatory joint or skin disease or overlap syndromes as the
primary disease.

15. Clinically significant or unstable or uncontrolled acute or chronic disease not due to
SLE

16. Does not meet required laboratory criteria.

17. Pregnant or a breast-feeding female.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Marla Hochfeld, MD
Study Director
Celgene Corporation

Overall Contact

Last Name

Associate Director Clinical Trial Disclosure

Phone

1-888-260-1599

Email



Location

Facility

Status

AZ Arthritis and Rheum Rsch, PLLC
Mesa Arizona 85202 United States
Not yet recruiting
Saint Jude Heritage Medical Center
Fullerton California 92835 United States
Not yet recruiting
University of California San Diego Medical Center
La Jolla California 92037 United States
Not yet recruiting
UCLA Division of Rheumatology
Los Angeles California 90095 United States
Not yet recruiting
Desert Medical Advances
Palm Desert California 92260 United States
Recruiting
C Michael Neuwelt M D
San Leandro California 94578 United States
Not yet recruiting
Inland Rheumatology Clinical Trials
Upland California 91786 United States
Recruiting
University of Colorado Denver
Aurora Colorado 80045 United States
Not yet recruiting
Yale University School of Medicine
New Haven Connecticut 06520 United States
Not yet recruiting
University of Florida College of Medicine
Gainesville Florida 32610 United States
Not yet recruiting
University of Miami
Miami Florida 33136 United States
Not yet recruiting
Integral Rheumatology and Immunology Specialists
Plantation Florida 33324 United States
Not yet recruiting
Bay Care Medical Group
Tampa Florida 33614 United States
Recruiting
Emory University School of Medicine
Atlanta Georgia 30303 United States
Not yet recruiting
Jefrey Lieberman, MD, PC
Decatur Georgia 30033-5910 United States
Not yet recruiting
University of Maryland - School of Medicine
Baltimore Maryland 21201 United States
Not yet recruiting
Arthritis and Osteoporosis Associates of New Mexico
Las Cruces New Mexico 88011-4741 United States
Recruiting
North Shore-LIJ Health System-Division of Rheumatology
Great Neck New York 11021 United States
Not yet recruiting
NYU Langone Medical Center
New York New York 10016 United States
Not yet recruiting
SUNY Upstate Medical University
Syracuse New York 13210 United States
Not yet recruiting
Montefiore Medical Center
The Bronx New York 10461 United States
Not yet recruiting
DJL Clinical Research
Charlotte North Carolina 28210 United States
Recruiting
Shanahan Rheumatology and Immunotherapy
Raleigh North Carolina 27617 United States
Not yet recruiting
MetroHealth Medical Systems
Cleveland Ohio 44109 United States
Not yet recruiting
Hershey Medical Center
Hershey Pennsylvania 17033-8807 United States
Not yet recruiting
University of Pennsylvania Cancer Center
Philadelphia Pennsylvania 19104 United States
Not yet recruiting
University of Pittsburgh UPMC Lupus Center of Excellence
Pittsburgh Pennsylvania 15213 United States
Not yet recruiting
Advanced Rheumatology & Arthritis Research Center, PC
Wexford Pennsylvania 15090 United States
Not yet recruiting
Medical University of South Carolina
Charleston South Carolina 29425 United States
Not yet recruiting
UT Southwestern Medical Center
Dallas Texas 75390 United States
Not yet recruiting
Pioneer Research Solutions
Houston Texas 77099 United States
Recruiting
Virginia Mason Medical Center
Seattle Washington 98101 United States
Not yet recruiting
Organización Médica de Investigación
Buenos Aires C1015ABO Argentina
Not yet recruiting
Hospital General de Agudos Dr. Jose Maria Ramos Mejia
Buenos Aires C1221ADC Argentina
Not yet recruiting
Hospital Britanico de Buenos Aires
Buenos Aires C1280AEB Argentina
Not yet recruiting
Consultora Integral de Salud Centro Médico Privado
Cordoba 5000 Argentina
Not yet recruiting
CER Instituto Mèdico
Quilmes B1878DVB Argentina
Not yet recruiting
Instituto de Investigaciones Clinicas de Quilmes
Quilmes B1878GEG Argentina
Not yet recruiting
Centro Medico Privado de Reumatologia
San Miguel de Tucumán T4000AXL Argentina
Not yet recruiting
Hopital Erasme
Brussels 1070 Belgium
Not yet recruiting
Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg
Leuven 3000 Belgium
Not yet recruiting
CHU de Liege
Liège 4000 Belgium
Not yet recruiting
Centro Internacional de Pesquisas
Goiânia Goiás 74110-120 Brazil
Not yet recruiting
Centro de Estudos em Terapias Inovadoras LTDA
Curitiba Paraná 80030 Brazil
Not yet recruiting
LMK Servicos Medicos S/S
Porto Alegre Rio Grande do Sul 90480 Brazil
Not yet recruiting
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte 30150-221 Brazil
Not yet recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, RS 90035-003 Brazil
Not yet recruiting
Hospital Universitario Clemente Fraga Filho
Rio de Janeiro 20194-930 Brazil
Not yet recruiting
Centro de Imunoterapia de Ipanema (CITIPA)
Rio de Janeiro 22411-001 Brazil
Not yet recruiting
The University of Calgary
Calgary Alberta T2N 4Z6 Canada
Not yet recruiting
University of Manitoba
Winnipeg Manitoba R3Y1X7 Canada
Not yet recruiting
MAC Research Incorporated
Hamilton Ontario L8N 2B6 Canada
Recruiting
Toronto Western Hospital
Toronto/Ontario Ontario M5T 2S8 Canada
Not yet recruiting
CHUL du CHU de Quebec
Quebec G1V 4G2 Canada
Not yet recruiting
Clinique de Rhumatologie Du Centre Du Quebec
Quebec G8Z 1Y2 Canada
Recruiting
IPS Centro Integral de Reumatologia del Caribe Circaribe S.A.S.
Barranquilla 080002 Colombia
Not yet recruiting
Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S. - Cireem S.A.S
Bogota 110221 Colombia
Not yet recruiting
Idearg S.A.S.
Bogota 111211 Colombia
Not yet recruiting
Medicity S.A.S.
Bucaramanga 680003 Colombia
Not yet recruiting
Servimed S.A.S.
Bucaramanga 680003 Colombia
Not yet recruiting
Preventive Care
Chia 250001 Colombia
Not yet recruiting
Reumalab - Centro Integral de Reumatologia
Medellin 050010 Colombia
Not yet recruiting
Hospital Pablo Tobon Uribe
Medellin 050034 Colombia
Not yet recruiting
CHRU de Lille FR
Lille France
Not yet recruiting
Hopital de la Pitie Salpetriere - AP HPService d'hematologie
Paris 75651 France
Not yet recruiting
CHU Hautepierre
Strasbourg 67098 France
Not yet recruiting
Universitätsklinikum Schleswig-Holstein
Kiel 24105 Germany
Not yet recruiting
Universitaetsklinikum Koeln
Koeln 50937 Germany
Not yet recruiting
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz 55131 Germany
Not yet recruiting
Qualiclinic kft
Budapest 1036 Hungary
Recruiting
Egyesitett Szent Istvan es Szent Laszlo Korhaz - Rendelointezet
Budapest 1097 Hungary
Recruiting
Bekes Megyei Kozponti Korhaz
Gyula 5700 Hungary
Recruiting
ASST Spedali Civili P.O. di Brescia
Brescia 25123 Italy
Not yet recruiting
University of Ferrara, Azienda Ospedaliera-Universitaria S.Anna
Ferrara 44124 Italy
Not yet recruiting
Azienda Ospedaliero - Universitaria di Cagliari
Monserrato 09042 Italy
Not yet recruiting
Azienda Ospedaliera Di Padova
Padova 35128 Italy
Not yet recruiting
Azienda Ospedaliera Universitaria Pisana
Pisa 56126 Italy
Not yet recruiting
Biológicos Especializados S.A. de C.V.
Mexico Distrito Federal 06700 Mexico
Not yet recruiting
Clinica Integral de Osteoporosis y Artitis Reumatoide CLINOSAR
Mexico Distrito Federal 06760 Mexico
Not yet recruiting
Centro de Investigación y Tratamiento Reumatológico
Mexico Distrito Federal 44690 Mexico
Not yet recruiting
Centro Integral en Reumatología, S.A. de C.V.
Guadalajara Jalisco 44160 Mexico
Not yet recruiting
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara Jalisco 44280 Mexico
Not yet recruiting
Centro de Alta Especialidad en Reumatología e Investigación del Potosí S.C.
San Luis Potosi San Luis Potosí 78213 Mexico
Not yet recruiting
Unidad de Atencion Medica e Investigacion en Salud, S.C.
Merida Yucatán 97130 Mexico
Not yet recruiting
Hospital Angeles Lindavista
D.f, Df 07760 Mexico
Not yet recruiting
Centro en Investigacion y Manejo Reumatologico Sanatorio Toluca
Toluca 50120 Mexico
Not yet recruiting
Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy
Bydgoszcz 85-168 Poland
Not yet recruiting
Samodzielny Publiczny Zespól Opieki Zdrowotnej w Koscianie Szpital im. Teodora Dunina
Koscian 64-000 Poland
Not yet recruiting
Centrum Medyczne Plejady
Krakow 30-349 Poland
Not yet recruiting
Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Reumatologii i Ukladowych Chorob Tkanki Laczne
Lublin 20-954 Poland
Not yet recruiting
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.
Wroclaw 53-224 Poland
Not yet recruiting
City Clinical Hospital
Kazan 420103 Russian Federation
Not yet recruiting
Kemerovo State Medical Academy
Kemerovo 650066 Russian Federation
Not yet recruiting
Institution of the Russian Academy of Medical Sciences Research Institute of Rheumatology of the Ru
Moscow 115522 Russian Federation
Not yet recruiting
Orenburg State Medical Academy
Orenburg 460000 Russian Federation
Not yet recruiting
Leningrad Regional Clinical Hospital
St. Petersburg 194291 Russian Federation
Not yet recruiting
State Higher Educational Institution
St. Petersburg 195067 Russian Federation
Not yet recruiting
Regional Clinical Hospital
Vladimir 600023 Russian Federation
Not yet recruiting
Voronezh Regional Clinical Hopsital #1, Voronezh State Medical Academy
Voronezh 394066 Russian Federation
Not yet recruiting
Institute of Rheumatology Belgrade
Belgrade 11000 Serbia
Not yet recruiting
Military Medical Academy
Belgrade 11000 Serbia
Not yet recruiting
Institute Niska Banja
Niska Banja 18205 Serbia
Not yet recruiting
Hospital Universitario a Coruna
A Coruña 15006 Spain
Not yet recruiting
Hospital Clinic de Barcelona
Barcelona 08036 Spain
Not yet recruiting
Hospital Universitario Vall D hebron
Barcelona 28040 Spain
Not yet recruiting
Hospital Universitario de Canarias
La Laguna 38320 Spain
Not yet recruiting
Hospital Universitario Araba - Txagorritxu
Vitoria-Gasteiz 01009 Spain
Not yet recruiting

Location Countries

Country

Argentina

Belgium

Brazil

Canada

Colombia

France

Germany

Hungary

Italy

Mexico

Poland

Russian Federation

Serbia

Spain

United States



Verification Date

2017-09-01

Lastchanged Date

2017-09-28

Firstreceived Date

2017-05-18

Responsible Party

Responsible Party Type

Sponsor


Keywords


Has Expanded Access

No

Condition Browse


Secondary Id

U1111-1195-7804

Number Of Arms

4

Arm Group

Arm Group Label

CC-220 0.45 mg QD Placebo Controlled Phase

Arm Group Type

Experimental

Description

At Weeks 0 to 24: CC-220 Placebo Controlled Phase: CC-220 0.45 mg once daily (QD)
At Weeks 24 to 52: CC-220 Active Treatment Phase: CC-220 0.45 mg once daily (QD)


Arm Group Label

C-220 0.3 mg QD Placebo Controlled Phase

Arm Group Type

Experimental

Description

At Weeks 0 to 24: CC-220 Placebo Controlled Phase: CC-220 0.3 mg once daily (QD)
At Weeks 24 to 52: CC-220 Active Treatment Phase: CC-220 0.30 mg once daily (QD)


Arm Group Label

CC-220 0.15 mg QD Placebo Controlled Phase

Arm Group Type

Experimental

Description

At Weeks 0 to 24: CC-220 Placebo Controlled Phase: CC-220 0.15 mg once daily (QD)
At Weeks 24 to 52: CC-220 Active Treatment Phase: CC-220 0.15 mg once daily (QD)


Arm Group Label

Placebo

Arm Group Type

Placebo Comparator

Description

Weeks 0 to 24: CC-220 Placebo Controlled Phase: placebo once daily (QD)



Firstreceived Results Date

N/A

Patient Data

Sharing Ipd

No


Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)


Study First Submitted

May 18, 2017

Study First Submitted Qc

May 18, 2017

Study First Posted

May 19, 2017

Last Update Submitted

September 28, 2017

Last Update Submitted Qc

September 28, 2017

Last Update Posted

October 2, 2017


ClinicalTrials.gov processed this data on October 02, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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