Safety and Efficacy of VAY736 in Patients With Primary Sjogren's Syndrome (pSS)

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT02962895

Collaborator

(none)

192

Enrollment

Locations

Arms

50.9

Actual Duration (Months)

3.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will determine the dose-response relationship of VAY736 for key efficacy and safety parameters

Condition or Disease	Intervention/Treatment	Phase
Primary Sjogren Syndrome	Biological: VAY736 Other: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

192 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Study of Safety and Efficacy of Multiple VAY736 Doses in Patients With Moderate to Severe Primary Sjogren's Syndrome (pSS)

Actual Study Start Date :

Jun 27, 2017

Actual Primary Completion Date :

Jun 30, 2020

Actual Study Completion Date :

Sep 23, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VAY736 dose 1 VAY736 low	Biological: VAY736 VAY736
Experimental: VAY736 dose 2 VAY736 medium	Biological: VAY736 VAY736
Experimental: VAY736 dose 3 VAY736 high	Biological: VAY736 VAY736
Placebo Comparator: Placebo Placebo control	Other: Placebo Placebo control

Outcome Measures

Primary Outcome Measures

Change in multi-dimensional disease activity [24 weeks]
Dose response measured by change multi-dimensional disease activity as assessed by the physician

Secondary Outcome Measures

Change in patient-reported disease activity measures [24 weeks]
Dose response measured by change in patient-reported disease activity measures
Change in quality of life measure by PRO [24 weeks]
Change in quality of life measure by patient reported outcome (PRO)
Change in salivary gland function measure by flow rate [24 weeks]
salivary gland function measure by flow rate
Incidence of Adverse events and Serious Adverse Events [24 weeks]
Number of participants with adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Fulfilled revised American European Consensus Group criteria for pSS
Seropositive at screening for anti-Ro/SSA antibodies
Screening ESSDAI value >=6 scored from 7 domains: articular, cutaneous, glandular, lymphoadenopathy, constitutional, biologic and hematologic.

Exclusion Criteria:

Secondary Sjogren's syndrome
Use of other investigational drugs
Active viral, bacterial or other infections
Positive hepatitis B, hepatitis C, HIV or tuberculosis test results at screening

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Plantation	Florida	United States	33324
2	Novartis Investigative Site	Indianapolis	Indiana	United States	46202
3	Novartis Investigative Site	Baltimore	Maryland	United States	21224
4	Novartis Investigative Site	Boston	Massachusetts	United States	02111
5	Novartis Investigative Site	Rochester	New York	United States	14618
6	Novartis Investigative Site	Pittsburgh	Pennsylvania	United States	15213
7	Novartis Investigative Site	Wexford	Pennsylvania	United States	15090
8	Novartis Investigative Site	Houston	Texas	United States	77030
9	Novartis Investigative Site	San Antonio	Texas	United States	78229
10	Novartis Investigative Site	Ciudad Autonoma de Bs As	Buenos Aires	Argentina	C1055AAF
11	Novartis Investigative Site	Caba		Argentina	1117
12	Novartis Investigative Site	Cordoba		Argentina	5000
13	Novartis Investigative Site	Cordoba		Argentina	X5016KEH
14	Novartis Investigative Site	Graz		Austria	8036
15	Novartis Investigative Site	Bruxelles		Belgium	1070
16	Novartis Investigative Site	Leuven		Belgium	3000
17	Novartis Investigative Site	Santiago		Chile	7500710
18	Novartis Investigative Site	Santiago		Chile	8207257
19	Novartis Investigative Site	Brest		France	29200
20	Novartis Investigative Site	Lille		France	59000
21	Novartis Investigative Site	Berlin		Germany	13353
22	Novartis Investigative Site	Freiburg		Germany	79106
23	Novartis Investigative Site	Muenchen		Germany	81377
24	Novartis Investigative Site	Wuerzburg		Germany	97080
25	Novartis Investigative Site	Budapest		Hungary	H-1097
26	Novartis Investigative Site	Szeged		Hungary	6720
27	Novartis Investigative Site	Ramat Gan		Israel	52621
28	Novartis Investigative Site	Rozzano	MI	Italy	20089
29	Novartis Investigative Site	Roma	RM	Italy	00161
30	Novartis Investigative Site	Udine	UD	Italy	33100
31	Novartis Investigative Site	Nagoya	Aichi	Japan	457 8510
32	Novartis Investigative Site	Sasebo-city	Nagasaki	Japan	857-1165
33	Novartis Investigative Site	Itabashi-ku	Tokyo	Japan	173-8610
34	Novartis Investigative Site	Shinjuku-ku	Tokyo	Japan	160 8582
35	Novartis Investigative Site	Rotterdam		Netherlands	3015 CE
36	Novartis Investigative Site	Lublin		Poland	20-954
37	Novartis Investigative Site	Almada		Portugal	2801 951
38	Novartis Investigative Site	Lisboa		Portugal	1050-034
39	Novartis Investigative Site	Lisboa		Portugal	1649-035
40	Novartis Investigative Site	Porto		Portugal	4099 001
41	Novartis Investigative Site	Brasov		Romania	500283
42	Novartis Investigative Site	Cluj Napoca		Romania	400006
43	Novartis Investigative Site	Ekaterinburg		Russian Federation	620028
44	Novartis Investigative Site	Orenburg		Russian Federation	460000
45	Novartis Investigative Site	St Petersburg		Russian Federation	190068
46	Novartis Investigative Site	St Petersburg		Russian Federation	195257
47	Novartis Investigative Site	Vigo	Pontevedra	Spain	36200
48	Novartis Investigative Site	La Laguna	Santa Cruz De Tenerife	Spain	38320
49	Novartis Investigative Site	Barcelona		Spain	08041
50	Novartis Investigative Site	Kaohsiung		Taiwan	81346
51	Novartis Investigative Site	Taichung		Taiwan	40447
52	Novartis Investigative Site	Taichung		Taiwan	40705
53	Novartis Investigative Site	Taipei		Taiwan	11490
54	Novartis Investigative Site	Westcliff-on-Sea	Essex	United Kingdom	SS0 0RY
55	Novartis Investigative Site	Birmingham		United Kingdom	B15 2TH
56	Novartis Investigative Site	Liverpool		United Kingdom	L9 7AL