NCT03627065 is a Phase 2 clinical trial of Parsaclisib in Primary Sjögren's Syndrome, sponsored by Incyte Corporation.

Who is sponsoring NCT03627065?

NCT03627065 is sponsored by Incyte Corporation.

What drugs are being tested in NCT03627065?

Interventions in NCT03627065: Parsaclisib.

What condition does NCT03627065 study?

NCT03627065 studies Primary Sjögren's Syndrome.

Is NCT03627065 still recruiting?

NCT03627065 is currently completed. Last updated 13 August 2021.

Are results published for NCT03627065?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-08-13 · How we verify

NCT03627065

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of INCB050465 in Primary Sjögren's Syndrome

Completed Phase 2 Results posted Last updated 13 August 2021

What this trial tests

Phase 2 trial testing Parsaclisib in Primary Sjögren's Syndrome in 10 participants. Completed in 2 January 2020.

Timeline

28 February 2019

Primary endpoint
7 December 2019

2 January 2020

Quick facts

Lead sponsor	Incyte Corporation
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	28 February 2019
Primary completion	7 December 2019
Estimated completion	2 January 2020
Sites	4 locations across United States

Drugs / interventions tested

Parsaclisib — full drug profile →

Conditions studied

Primary Sjögren's Syndrome — all drugs for Primary Sjögren's Syndrome →

Sponsor

Incyte Corporation — full company profile →

Who can join

18 and older, any sex, with Primary Sjögren's Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Participants With a 1 Point or Greater Change on the Salivary Gland Ultrasound (SGUS) Score for Parotid and Submandibular Glands Primary · Week 4 and Week 12

The SGUS is a combination of the scores of the 4 salivary glands (2 parotid and 2 submandibular) each gland is scored on a 5-point scale (0 to 4; 4 being more severe), with the maximum total score being 16.

Week 4

Group	Value	95% CI
Parsaclisib	0

Week 12

Group	Value	95% CI
Parsaclisib	0

Change From Baseline in Salivary CXCL13 Levels Secondary · Baseline, Week 4 and Week 12

To assess the impact of parsaclisib on salivary CXCL13.

Week 4

Group	Value	95% CI
Parsaclisib	0.96	± 0.1

Week 12

Group	Value	95% CI
Parsaclisib	1.98	± 1.4

Number of Participants With Treatment-emergent Adverse Events Secondary · Up to 21 weeks

Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.

Group	Value	95% CI
Parsaclisib	4

Change in Whole Salivary Flow Secondary · Baseline, Weeks 4, 8, and 12

Defined as change in stimulated and unstimulated whole salivary flow from baseline

Mean change in stimulated salivary flow Week 4

Group	Value	95% CI
Parsaclisib	0.07	± 0.152

Mean change in stimulated salivary flow Week 8

Group	Value	95% CI
Parsaclisib	-0.05	± 0.129

Mean change in stimulated salivary flow Week 12

Group	Value	95% CI
Parsaclisib	-0.05	± 0.144

Mean change in unstimulated salivary flow Week 4

Group	Value	95% CI
Parsaclisib	0.03	± 0.046

Mean change in unstimulated salivary flow Week 8

Group	Value	95% CI
Parsaclisib	0.07	± 0.109

Mean change in unstimulated salivary flow Week 12

Group	Value	95% CI
Parsaclisib	0.04	± 0.082

Change in EULAR Sjögren's Syndrome Disease Activity Index Secondary · Week 12

Defined as change in ESSDAI. The ESSDAI is a physician-assessed disease activity index for primary Sjögren's syndrome developed by the EULAR consortium. It consists of 44 items in 12 organ-specific 'domains' contributing to disease activity (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. An overall score i

Mean Change at Week 4

Group	Value	95% CI
Parsaclisib	-0.3	± 2.92

Mean Change at Week 8

Group	Value	95% CI
Parsaclisib	-2.0	± 4.12

Mean Change at Week 12

Group	Value	95% CI
Parsaclisib	-5.3	± 4.15

Change in EULAR Sjögren's Syndrome Patient Reported Index Secondary · Weeks 4, 8, and 12

Defined as Change in ESSPRI. EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Score is defined as the change in score between baseline (Week -1) and Week 12. The ESSPRI is a patient-reported, subjective symptom index for primary Sjögren's syndrome developed by the EULAR consortium. It consists of three questions covering the cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual doma

Mean Change at Week 4

Group	Value	95% CI
Parsaclisib	-1.9	± 2.26

Mean Change at Week 8

Group	Value	95% CI
Parsaclisib	-2.0	± 1.93

Mean Change at Week 12

Group	Value	95% CI
Parsaclisib	-1.8	± 1.98

Change in Symptom Scores for Dryness Secondary · Weeks 4, 8, and 12.

Defined as change in symptom scores for dryness of eyes, mouth, and vagina. The dryness questionnaire will ask participants to rate the dryness of eyes, mouth, or vagina (female participants only) with 24-hour recall using an 11-point numerical rating system ranging from 0 (no dryness) to 10

Change in Symptom Score for eye dryness at Week 4

Group	Value	95% CI
Parsaclisib	-2.6	± 2.96

Change in Symptom Score for eye dryness at Week 8

Group	Value	95% CI
Parsaclisib	-2.4	± 2.07

Change in Symptom Score for eye dryness at Week 12

Group	Value	95% CI
Parsaclisib	-2.4	± 2.64

Change in Symptom Score for mouth dryness at Week 4

Group	Value	95% CI
Parsaclisib	-2.8	± 2.64

Change in Symptom Score for mouth dryness at Week 8

Group	Value	95% CI
Parsaclisib	-2.1	± 2.41

Change in Symptom Score for mouth dryness at Week 12

Group	Value	95% CI
Parsaclisib	-3.6	± 2.99

Change in Symptom Score for vaginal dryness at Week 4

Group	Value	95% CI
Parsaclisib	-1.3	± 3.20

Change in Symptom Score for vaginal dryness at Week 8

Group	Value	95% CI
Parsaclisib	-2.3	± 3.50

Patient Global Impression of Change Questionnaire Secondary · Baseline, Weeks 4, 8, and 12

Defined as proportions of participants in each PGIC category. The PGIC asks a single question regarding how the patient is feeling since beginning new therapy. The questionnaire uses a 7-point scale (from 1 to 7), ranging from "very much improved, 1" to "very much worse, 7

Baseline

Group	Value	95% CI
Parsaclisib	0
Parsaclisib	0
Parsaclisib	0
Parsaclisib	9

Week 4

Group	Value	95% CI
Parsaclisib	0
Parsaclisib	0
Parsaclisib	0
Parsaclisib	3

Week 8

Group	Value	95% CI
Parsaclisib	0
Parsaclisib	0
Parsaclisib	0
Parsaclisib	2

Week 12

Group	Value	95% CI
Parsaclisib	0
Parsaclisib	0
Parsaclisib	0
Parsaclisib	2

Change in PROMIS Fatigue Short Form Secondary · Weeks 4, 8, and 12

Defined as change in PROMIS Fatigue short form. The PROMIS fatigue short form includes 7 items with a rating scale of 1 to 5, 1 being no fatigue and 5 being severe fatigue. The recall period is 7 days.

Change in Score at Week 4

Group	Value	95% CI
Parsaclisib	-2.6	± 4.03

Change in Score at Week 8

Group	Value	95% CI
Parsaclisib	-1.9	± 2.79

Change in Score at Week 12

Group	Value	95% CI
Parsaclisib	-1.7	± 2.87

Female Participants Only : Change in Female Sexual Function Index Secondary · Weeks 4, 8, and 12

Defined as change in FSFI. The FSFI is a brief, self-report measure of female sexual function (female participants only). The questionnaire contains 19 item sexual functioning questionnaire to rate sexual function between 2.0 and 36.0, where 2.0 is low sexual function and 36.0 is high sexual function. Difference in FSFI scores are reported.

Change in Functional Index at Week 4

Group	Value	95% CI
Parsaclisib	1.8	± 3.19

Change in Functional Index at Week 8

Group	Value	95% CI
Parsaclisib	2.8	± 4.76

Change in Functional Index at Week 12

Group	Value	95% CI
Parsaclisib	1.3	± 1.83

Change in European Quality of Life 5 Dimensions Questionnaire Secondary · Weeks 4, 8, and 12

Defined as change in EQ-5D. The EQ-5D is a standardized measure of health status. It consists of 5 questions, each with a 5-item rating scale plus a visual analog scale rating from 1 to 100 for overall health status. Higher score represents more severe symptoms.

Change in EQ5D at week 4

Group	Value	95% CI
Parsaclisib	7.2	± 17.34

Change in EQ5D at week 8

Group	Value	95% CI
Parsaclisib	0.7	± 28.05

Change in EQ5D at week 12

Group	Value	95% CI
Parsaclisib	-6.4	± 22.49

Percentage Change in Whole Salivary Flow Secondary · Baseline, Weeks 4, 8, and 12

Defined as change and percent change in stimulated and unstimulated whole salivary flow from baseline

Percent change in stimulated salivary flow Week 4

Group	Value	95% CI
Parsaclisib	17.57	± 36.225

Percent change in stimulated salivary flow Week 8

Group	Value	95% CI
Parsaclisib	-10.59	± 32.874

Percent change in stimulated salivary flow Week 12

Group	Value	95% CI
Parsaclisib	-16.07	± 41.754

Percent change in unstimulated salivary flow Week 4

Group	Value	95% CI
Parsaclisib	228.10	± 282.634

Percent change in unstimulated salivary flow Week 8

Group	Value	95% CI
Parsaclisib	307.56	± 601.557

Percent change in unstimulated salivary flow Week 12

Group	Value	95% CI
Parsaclisib	281.12	± 541.333

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 21 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Parsaclisib

Serious: 0/10 (0%)

Deaths: 0/10

Other adverse events (10 terms — click to expand)

Reaction	System	Parsaclisib
Arthralgia	Musculoskeletal and connective tissue disorders	—
Dental caries	Gastrointestinal disorders	—
Fall	Injury, poisoning and procedural complications	—
Gastroesophageal reflux disease	Gastrointestinal disorders	—
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	—
Nausea	Gastrointestinal disorders	—
Neurodermatitis	Skin and subcutaneous tissue disorders	—
Oral candidiasis	Infections and infestations	—
Pruritus	Skin and subcutaneous tissue disorders	—
Toothache	Gastrointestinal disorders	—

Data from ClinicalTrials.gov NCT03627065 adverse events section.

Sponsor's own description

The purpose of this study is to assess the impact of parsaclisib on the signs and symptoms of Sjögren's syndrome (SS).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting PI3K in cancer: mechanisms and advances in clinical trials.
Yang J, Nie J, Ma X, Wei Y, et al · · 2019 · cited 1142× · PMID 30782187 · DOI 10.1186/s12943-019-0954-x
PI3K inhibitors are finally coming of age.
Vanhaesebroeck B, Perry MWD, Brown JR, André F, et al · · 2021 · cited 353× · PMID 34127844 · DOI 10.1038/s41573-021-00209-1
Current State of Knowledge on Primary Sjögren's Syndrome, an Autoimmune Exocrinopathy.
Parisis D, Chivasso C, Perret J, Soyfoo MS, et al · · 2020 · cited 114× · PMID 32698400 · DOI 10.3390/jcm9072299
The Future of Targeted Treatment of Primary Sjögren's Syndrome: A Focus on Extra-Glandular Pathology.
Zeng W, Zhou X, Yu S, Liu R, et al · · 2022 · cited 12× · PMID 36430611 · DOI 10.3390/ijms232214135
Emerging treatment for Sjögren's disease: a review of recent phase II and III trials.
Fox RI, Fox CM, McCoy SS. · · 2023 · cited 9× · PMID 37127914 · DOI 10.1080/14728214.2023.2209720
Recent advances in the search for a targeted immunomodulatory therapy for primary Sjögren's syndrome.
Leverenz DL, St Clair EW. · · 2019 · cited 9× · PMID 31508200 · DOI 10.12688/f1000research.19842.1

Verify or expand the search:

Other trials of Parsaclisib

Trials testing the same drug.

NCT07149818 — A Single-arm Phase 2 Prospective Clinical Study of Linprixel in the Treatment of Relapsed/Refractory Autoimmune Hemolyti · not yet recruiting
NCT05083208 — PI3Kδ Inhibitor Parsaclisib Combined With Chidamide for the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma · Phase 1 · terminated
NCT04774068 — Romidepsin and Parsaclisib for the Treatment of Relapsed or Refractory T-Cell Lymphomas · Phase 1 · completed
NCT04509700 — Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies o · Phase 2 · active not recruiting
NCT04323956 — Parsaclisib Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma · Phase 1 · active not recruiting

Other Incyte Corporation trials

Trials by the same sponsor.

NCT07124078 — A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Di · Phase 2 · recruiting
NCT07441694 — Study of INCA036978 in Participants With Myeloproliferative Neoplasms · Phase 1 · recruiting
NCT07522073 — A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancre · Phase 3 · recruiting
NCT07448155 — A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INCA033989 Following Subcutaneous or Intravenous A · Phase 1 · active not recruiting
NCT07284849 — A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 i · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03627065 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Incyte Corporation
Last refreshed: 13 August 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03627065.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03627065

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of Parsaclisib

Other Incyte Corporation trials

Verify against primary sources