Trial · NCT04628936

Open-label Extension to the Phase 2 Crossover Study (PRESIDIO) Evaluating KZR-616 in Patients With PM and DM.

NCT04628936, Phase 2, Completed, Kezar Life Sciences, Inc.; results first posted 2024-06-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Open-label Extension to the Phase 2 Crossover Study (PRESIDIO) Evaluating KZR-616 in Patients With PM and DM. Trials, record NCT04628936. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04628936

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Trial

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

Title: Open-label Extension to the Phase 2 Crossover Study (PRESIDIO) Evaluating KZR-616 in Patients With PM and DM.
NCT number: NCT04628936
Status: Completed
Phases: Phase 2
Enrollment: 18 participants, actual
Lead sponsor: Kezar Life Sciences, Inc.
Conditions: Polymyositis, Dermatomyositis
Interventions: KZR-616
First posted: 2020-11-16
Last updated: 2025-11-19
Results first posted: 2024-06-05

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Mean Total Improvement Score (TIS) at OLE Week 48	48 weeks	The mean Total Improvement Score (TIS) at OLE Week 48, which ranges from 0 to 100 \[low of 0 to high of 100, where higher scores are better\]. The timeframe of 48 weeks was selected because it represented the maximum timeframe of dosing for the last patient enrolled as the study drug administration ended when the last patient enrolled completed 48 weeks of dosing.

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	Mean Total Improvement Score (TIS) at OLE Week 48	48 weeks	Nine (9) patients were enrolled in the OLE study at Week 48.	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group1

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

Outcome	Group	Category	Value	Spread	Units
Mean Total Improvement Score (TIS) at OLE Week 48	KZR-616 45 mg + Standard Therapy (Open-label)		36.4	Standard Deviation 23.2	score on a scale

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	KZR-616 45 mg + Standard Therapy (Open-label)	18
Overall Study	COMPLETED	KZR-616 45 mg + Standard Therapy (Open-label)	8
Overall Study	NOT COMPLETED	KZR-616 45 mg + Standard Therapy (Open-label)	10

Source ClinicalTrials.gov

Adverse events88

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	Angina pectoris	Cardiac disorders	KZR-616 45 mg + Standard Therapy (Open-label)	1	18	1
other	Diastolic dysfunction	Cardiac disorders	KZR-616 45 mg + Standard Therapy (Open-label)	1	18	1
other	Pericardial effusion	Cardiac disorders	KZR-616 45 mg + Standard Therapy (Open-label)	1	18	1
other	Dry eye	Eye disorders	KZR-616 45 mg + Standard Therapy (Open-label)	1	18	1
other	Keratitis	Eye disorders	KZR-616 45 mg + Standard Therapy (Open-label)	1	18	1
other	Abdominal distension	Gastrointestinal disorders	KZR-616 45 mg + Standard Therapy (Open-label)	1	18	1
other	Abdominal pain	Gastrointestinal disorders	KZR-616 45 mg + Standard Therapy (Open-label)	1	18	2
other	Abdominal pain upper	Gastrointestinal disorders	KZR-616 45 mg + Standard Therapy (Open-label)	1	18	1
other	Constipation	Gastrointestinal disorders	KZR-616 45 mg + Standard Therapy (Open-label)	1	18	1
other	Diarrhoea	Gastrointestinal disorders	KZR-616 45 mg + Standard Therapy (Open-label)	5	18	6

1 to 10 of 88Source ClinicalTrials.gov

See all 88 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	KZR-616 45 mg + Standard Therapy (Open-label)	0	18
Total, other adverse events	KZR-616 45 mg + Standard Therapy (Open-label)	17	18
Total, serious adverse events	KZR-616 45 mg + Standard Therapy (Open-label)	1	18

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license 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/NCT04628936

GET https://conductscience.org/api/trials/v1/NCT04628936/events?page=2

API reference For AI assistants