Clinical Trials Register

Summary
EudraCT Number:	2021-000648-23
Sponsor's Protocol Code Number:	M20-370
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2021-09-08
Trial 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

Italy - Italian Medicines Agency

A.2

EudraCT number

2021-000648-23

A.3

Full title of the trial

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate
the Safety and Efficacy of ABBV-154 in Subjects with Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment

Uno Studio Clinico di Fase 2 Randomizzato, In Doppio Cieco, Controllato Verso Placebo, di Ricerca della Dose per Valutare la Sicurezza e l'Efficacia di ABBV-154 in Soggetti Affetti da Polimialgia Reumatica (PMR) Glucocorticoide-Dipendente

A.3.1

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

This is a Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment

Si tratta di uno studio che intende valutare la sicurezza e l’efficacia di ABBV-154 in soggetti affetti da polimialgia reumatica (PMR) dipendente dal trattamento con glucocorticoidi

A.3.2

Name or abbreviated title of the trial where available

A Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of ABBV-154

Uno studio randomizzato, in doppio cieco, controllato con placebo, sulla sicurezza e l'efficacia di

A.4.1

Sponsor's protocol code number

M20-370

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	Global Clinical Trials Helpdesk
B.5.3	Address:
B.5.3.1	Street Address	AbbVie House, Vanwall Business Park, Vanwall 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	global-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	ABBV-154
D.3.2	Product code	[ABBV-154]
D.3.4	Pharmaceutical form	Solution for injection/infusion in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
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	ABBV-154
D.3.9.2	Current sponsor code	ABBV-154
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	40
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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.IMP: 2
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	ABBV-154
D.3.2	Product code	[ABBV-154]
D.3.4	Pharmaceutical form	Solution for injection/infusion in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
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	ABBV-154
D.3.9.2	Current sponsor code	ABBV-154
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	150
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	Solution for injection/infusion in pre-filled syringe
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Subjects with Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment

Soggetti affetti da polimialgia reumatica (PMR) dipendente dal trattamento con glucocorticoidi

E.1.1.1

Medical condition in easily understood language

Polymyalgia Rheumatica

Polimialgia reumatica

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	10036099
E.1.2	Term	Polymyalgia rheumatica
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 assess the safety and efficacy of ABBV-154 versus placebo in subjects with PMR, who are dependent on treatment with glucocorticoids with doses of at least 5 mg/day prednisone equivalent (glucocorticoid-dependent PMR).

Valutare la sicurezza e l’efficacia di ABBV-154 rispetto a placebo in soggetti affetti da PMR, che sono dipendenti dal trattamento con glucocorticoidi, a dosi di almeno 5 mg/die di prednisone o equivalente (PMR glucocorticoide dipendente).

E.2.2

Secondary objectives of the trial

To assess the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ABBV-154.

Valutare la farmacocinetica (PK), farmacodinamica (PD) e immunogenicità di ABBV-154

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

Other types of substudies
Specify title, date and version of each substudy with relative objectives: Wearable Device Substudy- For collection of subject's upper limbs range
of motion, daily activity, and sleep parameters.

Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Sottostudio con dispositivo indossabile-Per la raccolta di dati relativi all’ampiezza di movimento degli arti superiori, alle attività quotidiane e ai parametri relativi al sonno del soggetto.

E.3

Principal inclusion criteria

1. Adults 50 – 80 years of age with a clinical diagnosis of PMR and fulfillment of the 2012 EULAR/ACR provisional classification criteria for PMR.
2. Following a confirmed diagnosis of PMR, subject must have shown a clinical response to prednisone (or equivalent dose) of 5 to 25 mg/day.
3. Subject must have had at least 2 episodes of unequivocal PMR flare while attempting to taper prednisone, with the dose of prednisone (or equivalent) at the time of flare = 5 mg/day, prior to Baseline; the most recent flare must have been within 24 weeks of Baseline. Unequivocal PMR flare is defined as clinical signs and symptoms of PMR (shoulder and/or hip girdle pain with inflammatory stiffness, neck pain with inflammatory stiffness, or new or worsened limited range of
motion of hips and/or shoulders) that resulted in an increase in glucocorticoid dose.
4. Subject must be on a stable prednisone (or equivalent) dose of 5 to 15 mg/day for = 2 weeks prior to Baseline. Subjects may be on up to 25 mg/day at the Screening Visit provided that the subject is able to taper to 15 mg/day or less, with a stable dose = 2 weeks prior to Baseline.
5. Subject must be willing to follow the protocol-defined glucocorticoid tapering regimen.

1 Adulti di età compresa fra 50 e 80 anni con diagnosi clinica di PMR, e soddisfacimento dei criteri provvisori di classificazione per PMR EULAR/ACR 2012.
2 A seguito di una diagnosi confermata di PMR, il soggetto deve aver dimostrato una risposta clinica a prednisone (oppure dose equivalente) compresa fra 5 e 25 mg/die.
3 Il soggetto deve aver presentato almeno 2 episodi di riacutizzazione inequivocabile di PMR durante il tentativo di ridurre gradualmente prednisone, con la dose di prednisone (o equivalente) al momento della riacutizzazione pari a = 5 m g/die, prima del Baseline; la riacutizzazione più recente deve essere avvenuta entro le 24 settimane precedenti il Baseline. Per riacutizzazione inequivocabile di PMR si intendono segni e sintomi clinici di PMR (dolore alla spalla e/o cingolo pelvico con rigidità infiammatoria, dolore al collo con rigidità infiammatoria oppure restrizione dell’ampiezza di movimento a carico di anche e/o spalle, di nuova insorgenza o peggioramento di restrizione esistente) che ha portato ad un aumento della dose di glucocorticoidi.
4 Il soggetto deve essere in trattamento a dose stabile con prednisone (o equivalente) compresa tra 5 e 15 mg/die per = 2 settimane prima del Baseline. I soggetti possono essere in trattamento con dose fino a 25 mg/die al momento della Visita di Screening, purché il soggetto sia in grado di ridurre in maniera graduale fino a una dose pari o inferiore a 15 mg/die, con dose stabile da = 2 settimane prima del baseline.
5 Il soggetto deve essere disposto a seguire il regime di riduzione graduale dei glucocorticoidi definito dal protocollo.

E.4

Principal exclusion criteria

1. Subject must have discontinued use of immunomodulators other than prednisone (or equivalent) prior to Baseline
2. Subjects requiring > 25 mg/day of prednisone to control confirmed PMR are excluded
3. Subject must not exhibit clinical signs and symptoms of PMR (shoulder and/or hip girdle pain with inflammatory stiffness, neck pain with inflammatory stiffness, or new or worsened limited range of motion of hips and/or shoulders) within 2 weeks of Baseline

1 Il soggetto deve aver interrotto l’uso di immunomodulatori diversi dal prednisone (oppure equivalente) prima del Baseline.
2 Sono esclusi i soggetti che necessitano di > 25 mg/die di prednisone per controllare PMR confermata
3 Il soggetto non deve presentare segni e sintomi clinici di PMR (dolore alla spalla e/o cingolo pelvico con rigidità infiammatoria, dolore al collo con rigidità infiammatoria oppure restrizione di movimento di anche e/o spalle di nuova insorgenza o peggioramento di restrizione esistente) nelle 2 settimane precedenti il Baseline.

E.5 End points

E.5.1

Primary end point(s)

Time to flare, where flare is defined as follows:
• Presence of clinical signs and symptoms of PMR
AND
• Requirement to increase the glucocorticoid dose per investigator.

Clinical signs and symptoms of PMR are defined as shoulder and/or hip girdle pain with inflammatory stiffness, neck pain with inflammatory stiffness, or new or worsened limited range of motion of hips and/or shoulders that are not due to other causes

Tempo alla riacutizzazione, ove la riacutizzazione è definita come segue:
· Presenza di segni e sintomi clinici di PMR
IN AGGIUNTA A
· Necessità, a giudizio del medico sperimentatore, di aumentare la dose di glucocorticoidi.

Per segni e sintomi clinici di PMR si intendono dolore a spalla e/o al cingolo pelvico associato a rigidità infiammatoria, dolore al collo con rigidità infiammatoria oppure restrizione dell’ampiezza del movimento, di nuova insorgenza o peggioramento della restrizione esistente, di anche e/o spalle che non sia dovuta ad altre cause.

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 24

Settimana 24

E.5.2

Secondary end point(s)

• Achievement of flare-free state up to Week 24
• Cumulative glucocorticoid dose by 24 weeks
• Change from Baseline in glucocorticoid dose at Week 24

· Ottenimento dello stato di libero da riacutizzazioni fino alla Settimana 24
· Dose cumulativa di glucocorticoidi entro 24 settimane
· Variazione rispetto al Baseline della dose di glucocorticoidi alla Settimana 24

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 24

Settimana 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

Yes

E.6.13.1

Other scope of the trial description

Also assess Immunogenicity of ABBV-154

Valutare anche l'immunogenicità di ABBV-154

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

Information not present in EudraCT

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

Australia

Canada

Japan

Korea, Republic of

New Zealand

United States

Austria

France

Germany

Hungary

Italy

Netherlands

Poland

Spain

United Kingdom

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 visit or date of the last follow-up contact, whichever is later.

Per fine dello studio si intende la data dell’ultima visita dell’ultimo soggetto oppure la data dell’ultimo contatto di follow-up, quale dei due avvenga per ultimo.

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:

150

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

200

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)

Upon completion of the study, the subjects will be treated in accordance with the Investigator's best clinical judgement.

Una volta completato lo studio, i soggetti saranno trattati secondo il miglior giudizio clinico del medico sperimentatore.

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

2021-12-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-10-05

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2023-04-27

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