Brief Summary

The primary objective of the study is to check if an subcutaneous (sc) infusion of UCB7665 is safe and tolerated in subjects with primary immune thrombocytopenia.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Mar 2016

Typical duration for phase_2

Geographic Reach

11 countries

29 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.9 years study duration

Study Start

First participant enrolled

March 2, 2016

Completed

9 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2016

Completed

13 days until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2019

Completed

5 years until next milestone

Results Posted

Study results publicly available

January 29, 2024

Completed

Last Updated

January 29, 2024

Status Verified

May 1, 2023

Enrollment Period

2.9 years

First QC Date

March 11, 2016

Results QC Date

May 15, 2023

Last Update Submit

May 15, 2023

Conditions

Thrombocytopenia

Keywords

ITP

Outcome Measures

Primary Outcomes (1)

Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (TEAE) During the Study
TEAEs were defined as Adverse Events starting after the time of first Investigational Medicinal Product (IMP) administration up to and including 8 weeks after the final dose.
From Visit 2 (Week 1) until End of Study Visit or Early Termination (up to 12 weeks after the first investigational medicinal product (IMP) administration)

Study Arms (5)

UCB7665 4 mg/kg

EXPERIMENTAL

Participants in this arm received 5 subcutaneous (sc) doses of UCB7665 (rozanolixizumab) 4 milligram per kilograms (mg/kg) at 1-week intervals.

Drug: UCB7665

UCB7665 7 mg/kg

EXPERIMENTAL

Participants in this arm received 3 sc doses of UCB7665 (rozanolixizumab) 7 mg/kg at 1-week intervals.

Drug: UCB7665

UCB7665 10 mg/kg

EXPERIMENTAL

Participants in this arm received 2 sc doses of UCB7665 (rozanolixizumab) 10 mg/kg at 1-week intervals.

Drug: UCB7665

UCB7665 15 mg/kg

EXPERIMENTAL

Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 15 mg/kg.

Drug: UCB7665

UCB7665 20 mg/kg

EXPERIMENTAL

Participants in this arm received 1 sc dose of UCB7665 (rozanolixizumab) 20 mg/kg.

Drug: UCB7665

Interventions

UCB7665DRUG

* Intervention Type: Biological/Vaccine * Pharmaceutical Form: Powder for solution for infusion * Concentration: 100 mg/ml - Route of Administration: Subcutaneous infusion

Also known as: rozanolixizumab

UCB7665 10 mg/kgUCB7665 15 mg/kgUCB7665 20 mg/kgUCB7665 4 mg/kgUCB7665 7 mg/kg

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subject has a diagnosis of primary immune thrombocytopenia (ITP) for a minimum of 3 months prior to Screening Visit
Subject has a platelet count \<30x10\^9/L at Screening and \<35x10\^9/L at Baseline (Visit 2)
Subject has a current or history of a peripheral blood smear consistent with ITP
Subject has responded to previous ITP therapy (according to the judgment of the investigator)

You may not qualify if:

Subject has an immunoglobulin G (IgG) level \<=6g/L at Screening Visit
Subject has a partial thromboplastin time (PTT) \>=1.5x upper limit of normal (ULN) or International Normalized Ratio (INR) \>=1.5 at Screening Visit
Subject has renal and/or liver impairment defined as:
Serum creatinine level of \>=1.4 mg/dL for females and \>=1.5 mg/dL for males at Screening Visit
Subject has planned an elective surgical procedure in the coming 6 months
Subject has evidence of a secondary cause of primary immune thrombocytopenia purpura
Subject has a history of clinically relevant ongoing chronic infections
Subject has a family history of primary immunodeficiency
Subject has a clinically relevant active infection or has had a serious infection within 6 weeks prior to the first dose of IMP
Subject has a history of known inflammatory bowel disease, diverticular disease, and gastric or esophageal ulceration
Subject has experienced gastrointestinal bleed in the last 6 months prior to Screening Visit and/or has current gastritis or esophagitis
Subject has a medical history of thrombosis
Subject has a history of coagulopathy disorders other than ITP
Subject has received a live vaccination within 8 weeks prior to the Baseline Visit; or intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of IMP
Subject has had prior treatment with rituximab in the 6 months prior to the Baseline Visit
+1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

UCB Biopharma SRLlead
Parexelcollaborator

Study Sites (29)

Tp0001 1101

Adelaide, Australia

Location

Tp0001 1302

Pleven, Bulgaria

Location

Tp0001 1301

Sofia, Bulgaria

Location

Tp0001 203

Olomouc, Czechia

Location

Tp0001 201

Prague, Czechia

Location

Tp0001 1201

Tbilisi, Georgia

Location

Tp0001 401

Berlin, Germany

Location

Tp0001 403

Düsseldorf, Germany

Location

Tp0001 404

München, Germany

Location

Tp0001 502

Florence, Italy

Location

Tp0001 506

Torino, Italy

Location

Tp0001 503

Udine, Italy

Location

Tp0001 505

Vicenza, Italy

Location

Tp0001 601

Chisinau, Moldova

Location

Tp0001 702

Bialystok, Poland

Location

Tp0001 703

Gdansk, Poland

Location

Tp0001 701

Lodz, Poland

Location

Tp0001 704

Poznan, Poland

Location

Tp0001 705

Warsaw, Poland

Location

Tp0001 802

Brasov, Romania

Location

Tp0001 801

Bucharest, Romania

Location

Tp0001 803

Craiova, Romania

Location

Tp0001 902

Madrid, Spain

Location

Tp0001 903

Madrid, Spain

Location

Tp0001 901

Valencia, Spain

Location

Tp0001 1001

London, United Kingdom

Location

Tp0001 1002

London, United Kingdom

Location

Tp0001 1003

London, United Kingdom

Location

Tp0001 1004

Truro, United Kingdom

Location

Related Publications (2)

Robak T, Kazmierczak M, Jarque I, Musteata V, Trelinski J, Cooper N, Kiessling P, Massow U, Woltering F, Snipes R, Ke J, Langdon G, Bussel JB, Jolles S. Phase 2 multiple-dose study of an FcRn inhibitor, rozanolixizumab, in patients with primary immune thrombocytopenia. Blood Adv. 2020 Sep 8;4(17):4136-4146. doi: 10.1182/bloodadvances.2020002003.
PMID: 32886753RESULT
Smith B, Kiessling A, Lledo-Garcia R, Dixon KL, Christodoulou L, Catley MC, Atherfold P, D'Hooghe LE, Finney H, Greenslade K, Hailu H, Kevorkian L, Lightwood D, Meier C, Munro R, Qureshi O, Sarkar K, Shaw SP, Tewari R, Turner A, Tyson K, West S, Shaw S, Brennan FR. Generation and characterization of a high affinity anti-human FcRn antibody, rozanolixizumab, and the effects of different molecular formats on the reduction of plasma IgG concentration. MAbs. 2018 Oct;10(7):1111-1130. doi: 10.1080/19420862.2018.1505464. Epub 2018 Sep 12.
PMID: 30130439DERIVED

MeSH Terms

Conditions

Thrombocytopenia

Interventions

rozanolixizumab

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Results Point of Contact

Title: UCB
Organization: Cares

Study Officials

UCB Cares
001 844 599 2273 (UCB)
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 11, 2016

First Posted

March 24, 2016

Study Start

March 2, 2016

Primary Completion

February 4, 2019

Study Completion

February 4, 2019

Last Updated

January 29, 2024

Results First Posted

January 29, 2024

Record last verified: 2023-05

Locations

MO(1)PL(5)ES(3)GB(4)AU(1)CZ(2)IT(4)DE(3)GE(1)BU(2)RO(3)

Study to Evaluate Safety, Tolerability and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (5)

UCB7665 4 mg/kg

UCB7665 7 mg/kg

UCB7665 10 mg/kg

UCB7665 15 mg/kg

UCB7665 20 mg/kg

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (29)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (5)

UCB7665 4 mg/kg

UCB7665 7 mg/kg

UCB7665 10 mg/kg

UCB7665 15 mg/kg

UCB7665 20 mg/kg

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (29)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations