Trial · NCT02718716

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

NCT02718716, Phase 2, Completed, UCB Biopharma SRL; results first posted 2024-01-29

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Study to Evaluate Safety, Tolerability and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia. Trials, record NCT02718716. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02718716

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study to Evaluate Safety, Tolerability and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia
NCT number: NCT02718716
Status: Completed
Phases: Phase 2
Enrollment: 66 participants, actual
Lead sponsor: UCB Biopharma SRL
Conditions: Thrombocytopenia
Interventions: UCB7665
First posted: 2016-03-24
Last updated: 2024-01-29
Results first posted: 2024-01-29

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (TEAE) During the Study	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)	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.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (TEAE) During the Study	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)	The Safety Set (SS) consisted of all study participants who had received at least 1 infusion (full or partial infusion) of rozanolixizumab and was used for the analysis of safety data.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group5

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (TEAE) During the Study	UCB7665 4 mg/kg (SS)	80.0	percentage of participants
Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (TEAE) During the Study	UCB7665 7 mg/kg (SS)	60.0	percentage of participants
Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (TEAE) During the Study	UCB7665 10 mg/kg (SS)	58.3	percentage of participants
Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (TEAE) During the Study	UCB7665 15 mg/kg (SS)	91.7	percentage of participants
Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (TEAE) During the Study	UCB7665 20 mg/kg (SS)	100	percentage of participants

Source ClinicalTrials.gov

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	UCB7665 4 mg/kg	15
Overall Study	STARTED	UCB7665 7 mg/kg	15
Overall Study	STARTED	UCB7665 10 mg/kg	12
Overall Study	STARTED	UCB7665 15 mg/kg	12
Overall Study	STARTED	UCB7665 20 mg/kg	12
Overall Study	COMPLETED	UCB7665 4 mg/kg	14
Overall Study	COMPLETED	UCB7665 7 mg/kg	15
Overall Study	COMPLETED	UCB7665 10 mg/kg	12
Overall Study	COMPLETED	UCB7665 15 mg/kg	12
Overall Study	COMPLETED	UCB7665 20 mg/kg	12

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events330

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	UCB7665 4 mg/kg (SS)	1	15	1
other	Anaemia	Blood and lymphatic system disorders	UCB7665 7 mg/kg (SS)	1	15	1
other	Anaemia	Blood and lymphatic system disorders	UCB7665 10 mg/kg (SS)	0	12	0
other	Anaemia	Blood and lymphatic system disorders	UCB7665 15 mg/kg (SS)	1	12	1
other	Anaemia	Blood and lymphatic system disorders	UCB7665 20 mg/kg (SS)	0	12	0
other	Immune thrombocytopenic purpura	Blood and lymphatic system disorders	UCB7665 4 mg/kg (SS)	0	15	0
other	Immune thrombocytopenic purpura	Blood and lymphatic system disorders	UCB7665 7 mg/kg (SS)	0	15	0
other	Immune thrombocytopenic purpura	Blood and lymphatic system disorders	UCB7665 10 mg/kg (SS)	0	12	0
other	Immune thrombocytopenic purpura	Blood and lymphatic system disorders	UCB7665 15 mg/kg (SS)	0	12	0
other	Immune thrombocytopenic purpura	Blood and lymphatic system disorders	UCB7665 20 mg/kg (SS)	1	12	1

1 to 10 of 330Source ClinicalTrials.gov

See all 330 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	UCB7665 4 mg/kg (SS)	0	15
Total, all-cause mortality	UCB7665 7 mg/kg (SS)	0	15
Total, all-cause mortality	UCB7665 10 mg/kg (SS)	0	12
Total, all-cause mortality	UCB7665 15 mg/kg (SS)	0	12
Total, all-cause mortality	UCB7665 20 mg/kg (SS)	0	12
Total, other adverse events	UCB7665 4 mg/kg (SS)	11	15
Total, other adverse events	UCB7665 7 mg/kg (SS)	9	15
Total, other adverse events	UCB7665 10 mg/kg (SS)	7	12
Total, other adverse events	UCB7665 15 mg/kg (SS)	10	12
Total, other adverse events	UCB7665 20 mg/kg (SS)	12	12

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30130439	DERIVED	PubMed
32886753	RESULT	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02718716

GET https://conductscience.org/api/trials/v1/NCT02718716/events?page=2

API reference For AI assistants