Clinical Trials Register

Summary
EudraCT Number:	2016-000518-31
Sponsor's Protocol Code Number:	LYC-30937-2001
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-08-30
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

Czechia - SUKL

A.2

EudraCT number

2016-000518-31

A.3

Full title of the trial

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

RANDOMIZOVANÁ, DVOJITĚ ZASLEPENÁ, PLACEBEM KONTROLOVANÁ STUDIE S PARALELNÍMI SKUPINAMI K POSOUZENÍ ÚČINNOSTI A BEZPEČNOSTI INDUKČNÍ TERAPIE S PŘÍPRAVKEM LYC 30937-EC U PACIENTŮ S AKTIVNÍ ULCERÓZNÍ KOLITIDOU

A.3.1

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

A STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS

STUDIE ZKOUMAJÍCÍ ÚČINNOST A BEZPEČNOST LÉČBY PŘÍPRAVKEM LYC-30937-EC U PACIENTŮ S ULCERÓZNÍ KOLITIDOU

A.4.1

Sponsor's protocol code number

LYC-30937-2001

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02762500

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Lycera Corp.
B.1.3.4	Country	United States
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	Lycera Corp.
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	Lycera Corp.
B.5.2	Functional name of contact point	Lycera Clinical Department
B.5.3	Address:
B.5.3.1	Street Address	2800 Plymouth Rd. NCRC, Building 26
B.5.3.2	Town/ city	Ann Arbor
B.5.3.3	Post code	MI 48109
B.5.3.4	Country	United States
B.5.4	Telephone number	0016104575095
B.5.5	Fax number	0017342073178
B.5.6	E-mail	30937_Clincal_Operations@Lycera.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.3.2	Product code	LYC-30937-EC
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LYC-30937
D.3.9.1	CAS number	1796641-10-5
D.3.9.2	Current sponsor code	LYC-30937
D.3.9.3	Other descriptive name	LYC-30937
D.3.9.4	EV Substance Code	SUB168579
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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	No
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	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Ulcerative Colitis

E.1.1.1

Medical condition in easily understood language

Ulcerative Colitis

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
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

The primary objective will be to assess the efficacy of LYC-30937-EC in inducing remission compared with placebo in subjects with active UC over a treatment duration of 8 weeks.

E.2.2

Secondary objectives of the trial

The secondary objectives will be to evaluate the safety, tolerability, plasma tissue PK of LYC-30937-EC compared with placebo in subjects with active UC.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Two pharmacokinetic sub studies will be part of the research: the safety pharmacokinetic substudy and the serial pharmacokinetic substudy. If patients agree to participate in one of these studies, extra blood will be taken to 1) determine plasma concentrations of LYC-30937, and 2) assess plasma PK parameters of LYC-30937 and its metabolite.

E.3

Principal inclusion criteria

1. Consenting adults aged 18–75 years.
2. Have had UC diagnosed at least 6 months prior to screening and with a minimum disease extent of ≥ 15 cm from the anal verge. The diagnosis of UC must be confirmed by endoscopic and histologic evidence (histology may be confirmed at screening based on biopsy collection during the screening colonoscopy with histological evaluation done by the site).
3. Have active UC defined as a TMS of 4–11 (inclusive) with endoscopic subscore of ≥ 2 and rectal bleeding subscore of ≥ 1 at screening.
4. Male and females subjects of childbearing potential must agree to use adequate birth control measures during the study. Female subjects of child bearing potential must use two highly effective forms of contraception, unless surgically sterilized, partner has had a vasectomy, or they will be abstinent, during study participation and for 30 days after their last dose of study drug. Highly effective methods of birth control in this study include: intrauterine device, hormonal contraceptives (oral, patch, long acting injectable, implant), double-barrier method (condom
or diaphragm with spermicide). (Post-menopausal defined as lack of menses for ≥ 6 months prior to screening confirmed with serum FSH > 25 mIU/mL at screening.)
5. If currently receiving any of the following UC treatments the duration and dose prior to the screening endoscopy must be as specified below and a stable dose should be maintained throughout the double-blind trial:
a. 5-aminosalicylates (5-ASA) (eg, mesalamine, sulfasalazine, olsalazine, balsalazide) for ≥ 6 weeks with the dose stable for ≥ 3 weeks prior to the Screening endoscopy.
b. Prednisone (dose ≤ 20 mg daily) or equivalent for ≥ 4 weeks and receiving a stable dose for ≥ 2 weeks prior to the screening endoscopy.
c. Thiopurines (azathioprine or 6-mercaptopurine) provided the dose has been stable for ≥ 8 weeks prior to screening endoscopy.
6. If oral aminosalicylates (ASA) or corticosteroids have been recently discontinued, they must have been stopped for ≥ 2 weeks prior to the screening endoscopy (eg, if recently tapered off corticosteroid). If a thiopurine has recently been discontinued it must have been stopped ≥4 weeks prior to the screening endoscopy.
7. Ability to provide written informed consent and to be compliant with the schedule of events.

E.4

Principal exclusion criteria

1. Known mitochondrial disorder.
2. History of CD or indeterminate colitis or the presence or history of a fistula consistent with CD.
3. History of bleeding disorders (eg, complement disorders, hemophilia,
history of uncontrolled bleeding).
4. Severe extensive disease that in physician judgment the subject is likely to require colonic surgery during the 8 week double-blind course (eg, fulminant colitis, toxic megacolon, bowel perforation, evidence of an acute abdomen).
5. Positive test for Clostridium (C.) difficile, positive stool culture for enteric pathogens (eg, Salmonella, Shigella, Campylobacter), or presence of ova or parasites at screening.
Note that C. difficile may be treated and the subject may be retested for screening after
he/she completed this treatment.
6. Any of the following laboratory abnormalities:
a. liver function tests > 1.5 x the upper limit of normal (ULN) or direct bilirubin > 1.5 x ULN.
b. hemoglobin < 8.5 g/dl (international system units [SI]: < 85 g/L).
c. neutrophils < 1500/mm3 (SI: < 1.5 x 109/L).
d. white blood cell (WBC) count < 3,000/mm3 (SI: < 3.0 x 109/L).
e. Platelets < 80,000 mm3 (SI: 80 x 109/L).
f. international normalized ratio (INR) > 1.5.
g. serum creatinine > 1.4 mg/dL for women or > 1.6 mg/dL for men.
7. Treatment with non-thiopurine immunosuppressant agents within 4 weeks prior to screening endoskopy (eg, cyclosporine, methotrexate, tacrolimus, sirolimus, or mycophenolate mofetil [MMF]).
8. Pregnancy, lactation, or a positive serum beta human chorionic gonadotropin (hCG) at
screening. Female subjects should not be planning to become pregnant while enrolled in the trial.
9. Clinically relevant hepatic, neurological, pulmonary, ophthalmological, gastrointestinal, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study.
10. History of uveitis within the 12 months prior to initiation of
screening procedures.

E.5 End points

E.5.1

Primary end point(s)

The proportion of subjects who achieve a clinical remission at Week 8 using the modified Mayo score (MMS). Clinical remission is defined as Mayo stool frequency subscore of ≤1, Mayo rectal bleeding subscore of 0 and Mayo endoscopy subscore of ≤1.

E.5.1.1

Timepoint(s) of evaluation of this end point

At week 8 of participation of a subject.

E.5.2

Secondary end point(s)

• The proportion of subjects who achieve clinical remission at Week 8 using the total Mayo score (TMS), defined as a Mayo score of ≤2, with no individual score >1, and rectal bleeding score of 0;
• The proportion of subjects with a clinical response at Week 8, defined as a reduction from Baseline MMS of ≥2 points and ≥25%, and a decrease from baseline in rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore of ≤1 point;
• The proportion of subjects with a clinical response at Week 8, defined as a reduction from Baseline in TMS of ≥3 points and ≥30%, and a decrease from Baseline in rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore of ≤1 point;
• The change from baseline TMS at Week 8;
• The change from baseline to Week 8 in fecal calprotectin.

E.5.2.1

Timepoint(s) of evaluation of this end point

At week 8 of participation of a patient.

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

Yes

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)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

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

Yes

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.8.4.1

Number of sites anticipated in Member State concerned

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

Canada

Czech Republic

Hungary

Netherlands

Poland

Serbia

United States

E.8.7

Trial has a data monitoring committee

Yes

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

Last visit of the last subject undergoing the trial.

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

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

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)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

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

120

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)

Patients will be able to enroll into an open label follow up study.

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

2016-11-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-09-14

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-03-26

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