Clinical Trials Register

Summary
EudraCT Number:	2019-003131-31
Sponsor's Protocol Code Number:	M19-956
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2019-12-12
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

Netherlands - Competent Authority

A.2

EudraCT number

2019-003131-31

A.3

Full title of the trial

A Phase 2a, Double-Blind, Randomized, Placebo-Controlled Study of Ravagalimab in Subjects with Moderately to Severely Active Primary Sjogren’s Syndrome.

A.3.1

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

Ravagalimab Vs Placebo in Subjects with Moderately to Severely Active Primary Sjogren's Syndrome

A.4.1

Sponsor's protocol code number

M19-956

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	AbbVie Deutschland GmbH & Co. KG
B.1.3.4	Country	Germany
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	AbbVie Inc.
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	AbbVie Ltd
B.5.2	Functional name of contact point	EU Clinical Trials Helpdesk
B.5.3	Address:
B.5.3.1	Street Address	AbbVie House, Vanwell Business Park, Vanwell Road
B.5.3.2	Town/ city	Maidenhead
B.5.3.3	Post code	SL6 4UB
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	441628561090
B.5.5	Fax number	441628461153
B.5.6	E-mail	eu-clinical-trials@abbvie.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	Ravagalimab
D.3.2	Product code	ABBV-323
D.3.4	Pharmaceutical form	Powder for concentrate for solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Ravagalimab
D.3.9.2	Current sponsor code	ABBV-323
D.3.9.3	Other descriptive name	ABBV-323
D.3.9.4	EV Substance Code	SUB192927
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	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	Powder for concentrate for solution for injection/infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Moderately to Severely Active Primary Sjogren's Syndrome

E.1.1.1

Medical condition in easily understood language

An autoimmune disease affecting the entire body; symptoms include dry mouth, and serious complications such as profound fatigue, chronic pain, major organ involvement, neuropathies and lymphomas.

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	21.0
E.1.2	Level	PT
E.1.2	Classification code	10040767
E.1.2	Term	Sjogren's syndrome
E.1.2	System Organ Class	10028395 - Musculoskeletal and connective tissue disorders

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 safety and efficacy of ravagalimab vs placebo for the treatment of Primary Sjogren's Syndrome (pSS) in subjects with moderately to severely active Primary Sjogren's Syndrome (pSS).

E.2.2

Secondary objectives of the trial

Not applicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Adult male or female, between 18 and 75 years of age, inclusive, at time of the Screening.
• Primary Sjogren’s syndrome (pSS) diagnosed according to the American College of Rheumatology (ACR)/EULAR 2016 Criteria.
• Lymphocyte focus score (local lymphocytic infiltrates) ≥1 in sub labial salivary gland specimen. Subjects with biopsy obtained 24 months prior to Screening and meeting this criteriona will be eligible but must have a sub labial biopsy obtained at the Baseline Visit. Subjects without a prior sub labial biopsy within 24 months of Screening will obtain a biopsy for a lymphocyte focus score at Screening.
• EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) ≥5 at Screening and Baseline.
• EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) ≥ 6 at Screening and Baseline.

E.4

Principal exclusion criteria

1) Female subject who is not pregnant, breastfeeding, or considering becoming pregnant during the study or for approximately 84 days.

2) Subjects must have discontinued all immunosuppressants (i.e., azathioprine , methotrexate (MTX), leflunomide (LEF), hydroxychloroquine (HCQ), chloroquine, sulfasalazine, mycophenolate mofetil, rituximab, other biologics, or JAK inhibitors), other than corticosteroids (equivalent to prednisone ≤ 10 mg/day), prior to the Baseline, with the following washout:
• HCQ must be discontinued ≥ 6 months prior to Baseline
• LEF must be discontinued ≥ 6 months prior to Baseline
• 1 year for rituximab OR 6 months if B cells have returned to pretreatment level or normal reference range (local laboratory) if pretreatment levels are not available;
• Discontinuation or modification of all other immunosuppressants must occur ≥ 4 weeks prior to Baseline or at least five times the mean terminal elimination half-life of the drug before undergoing the Baseline, whichever is longer.

3) Subject must not receive IV anti-infectives within 35 days prior to Baseline or oral/intramuscular (IM) anti-infectives within 14 days prior to the Baseline

E.5 End points

E.5.1

Primary end point(s)

The change from Baseline (CFB) in EULAR Sjogren’s Syndrome Disease Activity Index (ESSDAI)

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 24

E.5.2

Secondary end point(s)

The secondary endpoints including the following:
• CFB (Change from baseline) in EULAR Sjogren’s Syndrome Disease Activity Index (ESSDAI) at Weeks 4, 8, 12, and 16
• CFB in EULAR Sjogren’s Syndrome Patient Reported Index (ESSPRI) at Weeks 4, 8, 12,16, and 24
• CFB in tender joint count and swollen joint count (68/66) at Weeks 4, 8, 12, 16, and 24
• CFB in salivary flow, unstimulated at Weeks 4, 8, 12, 16, and 24
• CFB in salivary flow, stimulated, at Weeks 4, 8, 12, 16, and 24
• CFB in lacrimal flow (Schirmer’s test of ocular function) at Weeks 4, 8, 12, 16, and 24
• CFB in tear break-up time at Weeks 4, 8, 12,16 and 24
• CFB in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) at Weeks 4, 8, 12, 16, and 24
• CFB in patient and physician global assessments using Numeric Rate Scale (NRS) at Week 4, 8, 12, 16, and 24
• CFB in Anti-SSA, Anti-SSB, ANA and RF at Weeks 4, 12, and 24
• CFB in hsCRP, IgM, IgG, IgA, Serum free light chains, C3, C4 and CH50 at Weeks 4, 8, 12, 16, and 24
• CFB in Focus score of sub-labial gland biopsy at Week 24.

E.5.2.1

Timepoint(s) of evaluation of this end point

Weeks 4, 8, 12, 16, and 24

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

Yes

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

Yes

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

The end of study is defined as the date of the last subject's last contact,
which will be a follow-up phone call 84 days after the last dose.

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

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)

Investigator will use discretion on how to treat patient.

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

2019-12-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-02-05

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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