Clinical Trials Register

Summary
EudraCT Number:	2012-004366-18
Sponsor's Protocol Code Number:	CNTO148UCO1001
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:
Date on which this record was first entered in the EudraCT database:	2015-09-28
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

France - ANSM

A.2

EudraCT number

2012-004366-18

A.3

Full title of the trial

A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFα Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis

A.3.2

Name or abbreviated title of the trial where available

PURSUIT PEDS PK

A.4.1

Sponsor's protocol code number

CNTO148UCO1001

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/106/2012

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Janssen Biologics B.V.
B.1.3.4	Country	Netherlands
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Janssen Research & Development
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Janssen-Cilag International NV
B.5.2	Functional name of contact point	Clinical Registry Group
B.5.3	Address:
B.5.3.1	Street Address	Archimedesweg 29
B.5.3.2	Town/ city	Leiden
B.5.3.3	Post code	2333 CM
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	+31 71 524 2166
B.5.5	Fax number	+31 71 524 2110
B.5.6	E-mail	ClinicalTrialsEU@its.jnj.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Golimumab
D.3.2	Product code	CNTO148
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Golimumab
D.3.9.1	CAS number	476181-74-5
D.3.9.2	Current sponsor code	CNTO148
D.3.9.3	Other descriptive name	Human anti-TNF-alpha monoclonal antibody
D.3.9.4	EV Substance Code	SUB25638
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Monoclonal antibody

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Ulcerative Colitis in pediatric subjects

E.1.1.1

Medical condition in easily understood language

Ulcerative Colitis in pediatric subjects

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	LLT
E.1.2	Classification code	10045365
E.1.2	Term	Ulcerative colitis
E.1.2	System Organ Class	100000004856

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the PK of golimumab in pediatric subjects aged 2 through 17 years with moderately to severely active UC.

To evaluate the safety of golimumab in pediatric subjects aged 2 through 17 years with moderately to severely active UC.

E.2.2

Secondary objectives of the trial

To evaluate the efficacy of golimumab induction (ie, short-term therapy) in pediatric subjects aged 2 through 17 years with moderately to severely active UC.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Children aged 2 to 17 years of either gender.
• Have moderately to severely active ulcerative colitis (UC), defined as a baseline Mayo score of 6 to 12, inclusive.
• Had UC diagnosed, or was referred to the investigator to establish a diagnosis of UC, at least 2 weeks prior to screening.
• Have the diagnosis of UC confirmed by a previous biopsy (tissue or cell sample) or results from a biopsy conducted at the screening endoscopy procedure that is consistent with a diagnosis of UC.
• Have a Mayo endoscopy subscore ≥ 2 at screening sigmoidoscopy (procedure to examine the large intestine) [indicative of moderately to severely active UC]. A sigmoidoscopy performed within 2 weeks prior to baseline but before informed consent is obtained may be considered the screening sigmoidoscopy if performed by an investigator at the site.
• Prior or current medication for UC must include at least 1 of the following: a) current treatment with at least 1 of the following therapies: oral or intravenous corticosteroids, or the immunomodulators 6-MP or azathioprine (AZA); or b) have a history of failure to respond to or tolerate, or have a medical contraindication to, at least 1 of the following therapies: oral or intravenous corticosteroids or the immunomodulators 6-MP or AZA; or c) currently have or have had a history of corticosteroid dependency (ie, an inability to successfully taper corticosteroids without a return of the symptoms of UC); or d) have required more than 3 courses of oral or intravenous corticosteroids in the past year.

E.4

Principal exclusion criteria

• Have severe extensive colitis as evidenced by investigator judgment that the participant is likely to require a colectomy within 12 weeks of baseline; or symptom complex at screening or baseline visits that includes at least 4 of the following: 1) diarrhea with ≥ 6 bowel movements/day with macroscopic blood in stool; 2) focal severe or rebound abdominal tenderness; 3) persistent fever (≥ 37.5°C); 4) tachycardia (> 90 beats/minute); or 5) anemia (hemoglobin < 8.5 g/dL).
• Have UC limited to the rectum only or to < 20 cm of the colon.
• Presence of a stoma (a medical opening in the abdomen).
• Presence or history of a fistula (an abnormal passageway between two organs of the body).
• Have severe, fixed symptomatic stenosis (narrowing) of the large or small intestine.

E.5 End points

E.5.1

Primary end point(s)

• Serum golimumab concentration at Week 6
• Area under the curve (of serum concentrations) for golimumab from Week 0 to Week 6 (AUC0-6 weeks)

E.5.1.1

Timepoint(s) of evaluation of this end point

See E.5.1

E.5.2

Secondary end point(s)

• Number of adverse events up to Week 126
• Physical examination assessments up to Week 126
• Injection-site reactions up to Week 126
• Vital signs assessments up to Week 126
• Clinical laboratory tests up to Week 126
• Early detection of active tuberculosis up to Week 126
• Clinical response at Week 6
• Clinical remission at Week 6 as measured by the Mayo score, which includes stool frequency, rectal bleeding, endoscopy findings, and physician’s global assessment
• Pediatric Ulcerative Colitis Activity Index (PUCAI) remission up to Week 110. The PUCAI score includes abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel movement, and activity level.
• Mucosal healing at Week 6

E.5.2.1

Timepoint(s) of evaluation of this end point

See E.5.2

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

Open-Label Study to Assess the Safety and Pharmacokinetics

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Austria

Belgium

Canada

Denmark

France

Germany

Israel

Netherlands

Poland

United States

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

The end of study is defined as the completion of the final visit for the last subject 16 weeks after his or her last administration of study agent in the study.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Young children

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

At the end of the study extension, subjects who, in the opinion of the investigator, may benefit from continued treatment will be eligible to continue to receive golimumab until marketing authorization is obtained for golimumab in the treatment of pediatric UC in that country, or until a decision has been made not to pursue an indication in pediatric UC, whichever occurs first.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-08-08

Ethics Committee Opinion of the trial application

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

P. End of Trial
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