Clinical Trials Register

Summary
EudraCT Number:	2018-003149-41
Sponsor's Protocol Code Number:	IgPro20_2001
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-01-22
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2018-003149-41

A.3

Full title of the trial

A Multicenter, Randomized, Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20 (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in Adults with Systemic Sclerosis (SSc).

Studio multicentrico, randomizzato, in aperto, incrociato (crossover), di fase 2 per valutare la sicurezza e la farmacocinetica di IgPro20 (immunoglobulina sottocutanea, Hizentra®) e IgPro10 (immunoglobulina per via endovenosa, Privigen®) in adulti con sclerosi sistemica (SSc)

A.3.1

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

Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults with Systemic Sclerosis (SSc).

Sicurezza e farmacocinetica di IgPro20 e IgPro10 negli adulti con Sclerosi sistemica.

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

IgPro20_2001

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

ISRCTN00000000

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT00000000

A.5.3

WHO Universal Trial Reference Number (UTRN)

U0000-0000-0000

A.5.4

Other Identifiers

Name:

Number:

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	CSL BEHRING GMBH
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	CSL Behring GmbH
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	CSLB
B.5.2	Functional name of contact point	Trial Registration Coordinator
B.5.3	Address:
B.5.3.1	Street Address	1020 First Ave
B.5.3.2	Town/ city	King of Prussia,PA
B.5.3.3	Post code	19406
B.5.3.4	Country	United States
B.5.4	Telephone number	0016108784000
B.5.5	Fax number	000000000000000
B.5.6	E-mail	clinicaltrials@cslbehring.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	Yes
D.2.1.1.1	Trade name	Hizentra
D.2.1.1.2	Name of the Marketing Authorisation holder	CSL Behring GmbH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Immunoglobulina Normale Umana per somministrazione sottocutanea
D.3.2	Product code	[IgPro20]
D.3.4	Pharmaceutical form	Solution for injection
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	IMMUNOGLOBULINA UMANA NORMALE
D.3.9.2	Current sponsor code	IgPro20
D.3.9.4	EV Substance Code	SUB14196MIG
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	200
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)	Yes
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	Yes
D.2.1.1.1	Trade name	Privigen
D.2.1.1.2	Name of the Marketing Authorisation holder	CSL Behring GmbH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	immunoglobulina Normale Umana per somministrazione endovenosa
D.3.2	Product code	[IgPro10]
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	immunoglobulina normale umana
D.3.9.2	Current sponsor code	IgPro10
D.3.9.4	EV Substance Code	SUB14196MIG
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	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)	Yes
D.3.11.7	Plasma derived medicinal product	Yes
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Safety and Pharmacokinetics in subjects with diffuse cutaneous systemic
sclerosis

Sicurezza e farmacocinetica in soggetti con sclerosi sistemiche cutanee diffuse

E.1.1.1

Medical condition in easily understood language

Scleroderma (systemic sclerosis)

sclerosi sistemica

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	LLT
E.1.2	Classification code	10012977
E.1.2	Term	Diffuse systemic sclerosis
E.1.2	System Organ Class	100000004859

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of the study is to evaluate the safety of IgPro20 in
adults with dcSSc.

L’obiettivo primario dello studio è quello di valutare la sicurezza di IgPro20 in adulti con dcSSc.

E.2.2

Secondary objectives of the trial

The secondary objectives of the study are to evaluate:
• Relative bioavailability of IgPro20
• Pharmacokinetics of IgPro20
• Pharmacokinetics of IgPro10
• Safety of IgPro10

Gli obiettivi secondari dello studio sono di valutare:
• La biodisponibilità relativa di IgPro20
• La PK di IgPro20
• La PK di IgPro10
• La sicurezza di IgPro10

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Age = 18 years (male or female) at time of providing written informed consent
2. Documented diagnosis of systemic sclerosis (scleroderma) according to American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) criteria 2013 (diffuse cutaneous form of SSc).
3. mRSS = 15 and = 45 at screening
4. Disease duration = 5 years defined as the time from the first non-Raynaud's phenomenon manifestation
5. Capable of providing written informed consent and willing and able to adhere to all protocol requirements

• Età = 18 anni (maschio o femmina) al momento del consenso informato scritto
• Diagnosi documentata di sclerosi sistemica (sclerodermia) in base ai criteri dell’American College of Rheumatology e della European League Against Rheumatism del 2013 (forma cutanea diffusa di Ssc).
• Punteggio cutaneo Rodnan modificato (mRSS) = 15 e = 45 allo screening
• Durata della malattia = 5 anni definita come il tempo dalla prima manifestazione escluso il fenomeno di Raynaud
• Capacità di fornire il consenso informato scritto e capacità e disponibilità ad aderire a tutti i requisiti del protocollo

E.4

Principal exclusion criteria

1. Primary rheumatic autoimmune disease other than dcSSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, mixed connective tissue disorder, polymyositis, dermatomyositis, as determined by the investigator. Note: Subjects with fibromyalgia, secondary Sjogren's syndrome, and scleroderma-associated myopathy at screening are not excluded
2. Subject has mRSS > 2 at the potential subcutaneous (SC) infusion sites
3. History of skin condition precluding SC infusion, or clinical signs and symptoms of a chronic skin disease other than systemic sclerosis or skin manifestation of an allergic disease or other dermatological conditions that would interfere with trial assessments or compromise safety (eg, dermatitis, eczema, psoriasis)
4. Subject has clinical signs and symptoms of skin irritation (eg, pruritus, burning, erythema) or hypo/ hyperpigmentation (eg, scars, tattoos) at the potential SC infusion sites
5. Significant pulmonary arterial hypertension as documented by mean pulmonary arterial pressure > 30 mmHg on right heart catheterization requiring SC or IV prostacyclin or use of dual oral therapies
6. Forced vital capacity < 50% predicted or a diffusing capacity of the lung for carbon dioxide (DLCO) = 40% predicted (corrected for hemoglobin)
7. A female who is pregnant, breastfeeding, or is a woman of childbearing potential who does not agree to use acceptable methods of contraception; a male who does not agree to use acceptable methods of contraception.
8. Evidence of chronic kidney disease with an estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73m2 or if subject is receiving dialysis. Subjects with current confirmed diagnosis of diabetes mellitus requiring medication with an eGFR < 90 ml/min/1.73m2

• Malattia autoimmune reumatica primaria diversa dalla dcSSc determinata dallo
sperimentatore, compresa ma non limitato ad artrite reumatoide, lupus sistemico
eritematoso, malattia mista del tessuto connettivo, polimiosite, dermatomiosite. Nota:
Soggetti con fibromialgia, sindrome di Sjogren secondaria e miopatia associata a
sclerodermia allo screening non sono esclusi
• Il soggetto ha mRSS > 2 nei possibili siti di infusione SC
• Anamnesi di patologia cutanea o segni e sintomi clinici di una malattia cutanea
cronica diversa da SSc o manifestazione cutanea di una malattia allergica o altre
patologie dermatologiche che precludono l’infusione SC nei possibili siti di infusione
SC
• Il soggetto ha segni e sintomi clinici di irritazione cutanea (ad es. prurito,
bruciore, eritema) o ipo/iperpigmentazione (ad es. cicatrici, tatuaggi) nei possibili
siti di infusione SC
• Ipertensione arteriosa polmonare significativa come documentato dalla pressione
arteriosa polmonare media > 30 mmHg mediante cateterismo cardiaco destro che richieda prostaciclina SC o endovenosa (IV) o l’uso di terapie orali duplici
• FVC previsto < 50% o capacità di diffusione polmonare al monossido di carbonio
(DLCO) prevista = 40% (corretta per l’emoglobina) allo screening
• Crisi renale SSc nei 6 mesi precedenti lo screening
• Evidenza di malattia renale cronica con tasso di filtrazione glomerulare stimato <
30 l/min/1,73m2 o se il soggetto sta ricevendo la dialisi
• Per le donne: essere in gravidanza, in allattamento o potenzialmente fertili e non accettare di usare metodi adeguati di contraccezione; per gli uomini non accettare di usare metodi adeguati di contraccezione.
• Evidenza di malattia renale cronica con tasso di filtrazione glomerulare stimato (eGFR) < 45 mL/min/1,73m2 o se il soggetto è in dialisi. Soggetto con attuale diagnosi confermata di diabete mellito che necessita di medicinale con un eGFR < 90 ml/min/1,73m2

E.5 End points

E.5.1

Primary end point(s)

- Number and percentage of subjects with adverse events (AEs) for IgPro20
- Number and percentage of subjects with treatment emergent adverse events (TEAEs) for IgPro20
- Number and percentage of subjects with serious adverse events (SAEs) for IgPro20
- Number and percentage of subjects with adverse events of special interest (AESIs) for IgPro20
- Number and percentage of patients with AEs categorized as infusion site reactions (ISRs) for IgPro20
- Rate of ISRs per subject for IgPro20
- Rate of ISRs per infusion for IgPro20
- Onset of ISRs for IgPro20
- Duration of ISRs for IgPro20

• Numero e percentuale di soggetti con eventi avversi (AE) (totale, gravità, causalità ed esito) correlati a IgPro20
• Numero e percentuale di soggetti con eventi avversi emergenti dal trattamento (TEAE) per IgPro20
• Numero e percentuale di soggetti con eventi avversi seri (SAE) per IgPro20
• Numero e percentuale di soggetti con eventi avversi degni di nota (AESI) per IgPro20
• Numero e percentuale di soggetti con AE categorizzati come reazioni nel sito di iniezione (ISR) (totale, gravità, causalità e esito) di IgPro20
• Tasso delle ISR di IgPro20 per soggetto
• Tasso delle ISR di IgPro20 per infusione
• Insorgenza e durata delle ISR di IgPro20
• Cambiamento dal basale nei parametri vitali e peso corporeo, esami clinici di laboratorio, elettrocardiogramma (ECG) ed esami di funzionalità polmonare (PFT)

E.5.1.1

Timepoint(s) of evaluation of this end point

Up to 16 weeks

fno a 16 settimane

E.5.2

Secondary end point(s)

- IgPro20 relative bioavailability (%F)
- Area under the concentration curve to the end of the dosing period (AUC0-tau) for IgPro20
- Area under the concentration curve up to the last measurable concentration (AUC0-last) for IgPro20
- Maximum [peak] plasma drug concentration (Cmax) for IgPro20
- Minimum plasma drug concentration (Ctrough) for IgPro20
- Area under the concentration curve to the end of the dosing period (AUC0-tau) for IgPro10
- Area under the concentration curve up to the last measurable concentration (AUC0-last) for IgPro10
- Maximum [peak] plasma drug concentration (Cmax) for IgPro10
- Minimum plasma drug concentration (Ctrough) for IgPro10
- Number and percentage of subjects with adverse events (AEs) for IgPro10
- Number and percentage of subjects with treatment emergent adverse events (TEAEs) for IgPro10
- Number and percentage of subjects with serious adverse events (SAEs) for IgPro10
- Number and percentage of subjects with adverse events of special interest (AESIs) for IgPro10
- Number and percentage of subjects with AEs categorized as ISRs for IgPro10

• Biodisponibilità relativa di IgPro20 (%F)
• Parametri PK di IgPro20 (area sotto la curva [AUC]0-tau, AUC0 last, concentrazione plasmatica massima [picco] del farmaco [Cmax], concentrazione plasmatica minima
• Parametri PK IgPro10 (AUC0-tau, AUC0-last, Cmax, Ctrough)
• La sicurezza di IgPro10 in base a: numero e percentuale di AE, comprendente qualsiasi AE, AE emergenti dal trattamento e eventi avversi seri (SAE) e al cambiamento in altri esami clinici
• Numero e percentuale di soggetti con eventi avversi emergenti dal trattamento (TEAE) per IgPro10
• Numero e percentuale di soggetti con eventi avversi seri (SAE) per IgPro10
• Numero e percentuale di soggetti con eventi avversi degni di nota (AESI) per IgPro10

E.5.2.1

Timepoint(s) of evaluation of this end point

- Up to 16 weeks
- Up to 240 hours after first infusion
- Up to 240 hours after first infusion
- Up to 240 hours after first infusion
- Prior to infusion
- Up to 672 hours after first infusion
- Up to 672 hours after first infusion
- Up to 672 hours after first infusion
- Prior to infusion
- Up to 16 weeks
- Up to 16 weeks
- Up to 16 weeks
- Up to 16 weeks
- Up to 16 weeks

- Fino a 16 settimane
- Fino a 240 ore dopo la prima infusione
- Fino a 240 ore dopo la prima infusione
- Fino a 240 ore dopo la prima infusione
- Prima dell'infusione
- Fino a 672 ore dopo la prima infusione
- Fino a 672 ore dopo la prima infusione
- Fino a 672 ore dopo la prima infusione
- Prima dell'infusione
- Fino a 16 settimane
- Fino a 16 settimane
- Fino a 16 settimane
- Fino a 16 settimane
- Fino a 16 settimane

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

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)

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

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

Yes

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

Yes

E.8.2.3.1

Comparator description

Due periodi di trattamento: IgPro10 e poi IgPro20 o viceversa

Two treatment periods: IgPro10 and then IgPro20 or vice versa

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

France

Germany

Italy

Poland

United Kingdom

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 the clinical study (ie, completion of the study at all participating study sites) is defined as the date of the last visit of the last subject and consists of a telephone call to assess safety

La fine dello studio clinico (es. Completamento dello studio nei centri partecipanti) è definita come la data dell'ultima visita del ultimo paziente e consiste in una telefonata per valutare la sicurezza

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)

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)

None

Nessuno

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

2019-05-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-04-16

P. End of Trial
P.	End of Trial Status	Completed

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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