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TULIP SLE LTE: Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT02794285
Collaborator
PRA Health Sciences (Industry)
559
Enrollment
175
Locations
2
Arms
65.7
Actual Duration (Months)
3.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to characterise long-term safety and tolerability of intravenous anifrolumab.

Condition or Disease Intervention/Treatment Phase
  • Biological: Anifrolumab
  • Drug: Placebo
 Phase 3

Detailed Description

This is a Phase 3, multicentre, multinational, randomised, double-blind, placebo-controlled extension study to characterising the long term safety and tolerability of of an intravenous treatment regimen of anifrolumab versus placebo in subjects with moderately to severely active systemic lupus erythematosus who completed a Phase 3 study (D3461C00004 or D3461C00005) through the 52-week double-blind treatment period.

Study Design

Study Type:
Interventional
Actual Enrollment :
559 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus.
Actual Study Start Date :
Jun 30, 2016
Actual Primary Completion Date :
Dec 21, 2021
Actual Study Completion Date :
Dec 21, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Anifrolumab

Anifrolumab

Biological: Anifrolumab
Anifrolumab IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses
Placebo Comparator: Placebo

Placebo

Drug: Placebo
Placebo IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses

Outcome Measures

Primary Outcome Measures

  1. To measure the long-term safety and tolerability of IV anifrolumab by measuring the rates of adverse events of special interest and serious adverse events [Week 208]

    Rates of Adverse events of special interest and serious adverse events using incidence rates (ie number of events divided by person-time at risk)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Subjects who have qualified for and received investigational product (anifrolumab or placebo) and completed the treatment period in Studies D3461C00004 or D3461C00005 (through Week 52)

  2. Adequate peripheral venous access

  3. Females with an intact cervix should have documentation of a Pap smear with no documented malignancy within 90 days before Day 1/Visit 1 or 30 days following Day 1/Visit 1. Since access to a Pap smear may vary by country, the Sponsor recommends that local guidelines for obtaining Pap smears in subjects who have received immunomodulators or immunosuppressive treatment be followed.

  4. Meets the following TB criteria:

  5. Negative QuantiFERON®-TB Gold [QFT-G] test result for TB obtained from the study central laboratory at Week 52 of Studies D3461C00004 or D3461C00005; OR

  6. Newly positive QFT-G test result at Week 52 of Studies D3461C00004 or D3461C00005 from the study central laboratory. A chest x-ray must be performed. If the chest x-ray shows no evidence of active TB, and the subject has no symptoms or medical history consistent with active TB, the subject must have a retest. If the retest is positive, the subject must start on prophylaxis within 30 days of randomisation but prior to the second dose of investigational product (Visit 2/Week 4); OR

  7. Positive but not newly positive QFT-G test at Week 52 of Studies D3461C00004 or D3461C00005. The subject must have been diagnosed with latent TB and must have documentation confirming initiation of appropriate treatment OR initiate treatment for latent TB within 30 days of randomization, but prior to the second dose of investigational product administration (Visit 2/Week 4)

  8. Newly indeterminate (confirmed on retest unless prior positive QFT G was documented, along with completed treatment for latent TB) or indeterminate but not newly indeterminate QFT-G test result at Week 52 of Studies D3461C00004 or D3461C00005 from the study central laboratory with ongoing QFT-G testing for TB according to the Study Plan

  9. In the opinion of the Investigator, subject must be able to comprehend the ICF and all protocol related assessments

Exclusion Criteria:

  1. Receipt of any of the following within the last 60 days:

  2. Azathioprine >200 mg/day

  3. Mycophenolate mofetil >2.0 g/day /mycophenolic acid >1.44 g/day

  4. Oral, subcutaneous, or intramuscular methotrexate >25 mg/week

  5. Mizoribine >150 mg/day

  6. Receipt of any investigational product (small molecule or biologic agent other than anifrolumab) within 4 weeks or 5 half-lives prior to Day 1/Visit 1, whichever is greater

  7. Receipt of any of the following:

  8. Any live or attenuated vaccine within 8 weeks prior to Day 1/Visit 1 (administration of killed vaccines is acceptable, the Sponsor recommends Investigators ensure all subjects are up to date on required vaccinations, including influenza [inactivated/recombinant] vaccine prior to study entry)

  9. Bacillus Calmette-Guerin (BCG) vaccine between the end of Studies D3461C00004 or D3461C00005 and Day 1/Visit 1

  10. Active severe SLE-driven renal or neuropsychiatric disease

  11. Any underlying condition that predisposes the subject to infection, including history of/current human immunodeficiency virus (HIV) infection

  12. Subjects with Hepatitis B core antibody (HBcAb) positivity at enrolment of Studies D3461C00004 or D3461C00005 will be tested every 3 months for Hepatitis B virus (HBV) DNA. To remain eligible in the LTE study, subject HBV DNA levels must remain below the lower limit of quantitation as per the central laboratory.

  13. Opportunistic infection requiring hospitalisation or parenteral antimicrobial treatment within 3 years of Day 1/Visit 1

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Site Birmingham Alabama United States 35294-3280
2 Research Site El Cajon California United States 92020
3 Research Site Hemet California United States 92543
4 Research Site La Jolla California United States 92037
5 Research Site Los Alamitos California United States 90720
6 Research Site Los Angeles California United States 90095
7 Research Site San Leandro California United States 94578
8 Research Site Thousand Oaks California United States 91360
9 Research Site Upland California United States 91786
10 Research Site Aurora Colorado United States 80045
11 Research Site Denver Colorado United States 80230
12 Research Site Bridgeport Connecticut United States 06606
13 Research Site Brandon Florida United States 33511
14 Research Site DeBary Florida United States 32713
15 Research Site Miami Florida United States 33136
16 Research Site Miami Florida United States 33180
17 Research Site Ormond Beach Florida United States 32174
18 Research Site Tampa Florida United States 33614
19 Research Site Vero Beach Florida United States 32960
20 Research Site Atlanta Georgia United States 30322
21 Research Site Decatur Georgia United States 30033
22 Research Site Lawrenceville Georgia United States 30046
23 Research Site Marietta Georgia United States 30060
24 Research Site Boise Idaho United States 83702
25 Research Site Idaho Falls Idaho United States 83404
26 Research Site Cumberland Maryland United States 21502
27 Research Site Hagerstown Maryland United States 21740
28 Research Site Grand Rapids Michigan United States 49546
29 Research Site Minneapolis Minnesota United States 55455-0341
30 Research Site Nashua New Hampshire United States 03060
31 Research Site Freehold New Jersey United States 07728
32 Research Site Las Cruces New Mexico United States 88011
33 Research Site Brooklyn New York United States 11201
34 Research Site Great Neck New York United States 11021
35 Research Site New Hyde Park New York United States 11042
36 Research Site New York New York United States 10016
37 Research Site New York New York United States 10021
38 Research Site New York New York United States 10032
39 Research Site Charlotte North Carolina United States 28210
40 Research Site Charlotte North Carolina United States 28277
41 Research Site Greenville North Carolina United States 27834
42 Research Site Raleigh North Carolina United States 27617
43 Research Site Middleburg Heights Ohio United States 44130
44 Research Site Oklahoma City Oklahoma United States 73102
45 Research Site Oklahoma City Oklahoma United States 73104
46 Research Site Philadelphia Pennsylvania United States 19140
47 Research Site Pittsburgh Pennsylvania United States 15213
48 Research Site Reading Pennsylvania United States 19610
49 Research Site North Charleston South Carolina United States 29406
50 Research Site Memphis Tennessee United States 38104
51 Research Site Memphis Tennessee United States 38119
52 Research Site Amarillo Texas United States 79124
53 Research Site Austin Texas United States 78726
54 Research Site Austin Texas United States 78745
55 Research Site Dallas Texas United States 75231
56 Research Site Houston Texas United States 77004
57 Research Site Houston Texas United States 77034
58 Research Site Houston Texas United States 77074
59 Research Site Mesquite Texas United States 75150
60 Research Site Stafford Texas United States 77477
61 Research Site Spokane Washington United States 99204
62 Research Site Milwaukee Wisconsin United States 53217
63 Research Site Mendoza Argentina 5500
64 Research Site Quilmes Argentina 1878
65 Research Site San Miguel de Tucuman Argentina T4000AXL
66 Research Site Fitzroy Australia 3065
67 Research Site Kogarah Australia 2217
68 Research Site Plovdiv Bulgaria 4002
69 Research Site Plovdiv Bulgaria 4003
70 Research Site Hamilton Ontario Canada L8S 4K1
71 Research Site Rimouski Quebec Canada G5L 5T1
72 Research Site Osorno Chile 5311092
73 Research Site Santiago Chile 8320000
74 Research Site Vina del Mar Chile 2520997
75 Research Site Armenia Colombia 630004
76 Research Site Barranquilla Colombia 080002
77 Research Site Medellín Colombia 050021
78 Research Site Bordeaux France 33076
79 Research Site Lille France 59037
80 Research Site Montpellier CEDEX 5 France 34295
81 Research Site Paris Cedex 13 France 75651
82 Research Site Paris cedex 14 France 75014
83 Research Site Pessac France 33604
84 Research Site Berlin Germany 10117
85 Research Site Frankfurt am Main Germany 60528
86 Research Site Hamburg Germany 20246
87 Research Site Jena Germany 07747
88 Research Site Kirchheim Germany 73230
89 Research Site Mainz Am Rhein Germany 55131
90 Research Site Budapest Hungary 1097
91 Research Site Debrecen Hungary 4032
92 Research Site Szeged Hungary 6725
93 Research Site Zalaegerszeg Hungary 8900
94 Research Site Haifa Israel 31048
95 Research Site Haifa Israel 31096
96 Research Site Jerusalem Israel 91120
97 Research Site Kfar Saba Israel 49281
98 Research Site Tel Aviv Israel 64239
99 Research Site Chiba-shi Japan 260-8712
100 Research Site Chuo-ku Japan 104-8560
101 Research Site Fukuoka-shi Japan 810-0065
102 Research Site Fukuoka-shi Japan 810-8539
103 Research Site Hiroshima-shi Japan 730-8619
104 Research Site Kitakyushu-shi Japan 807-8556
105 Research Site Kurashiki-shi Japan 710-8522
106 Research Site Meguro-ku Japan 152-8902
107 Research Site Meguro-ku Japan 153-8515
108 Research Site Nagasaki-shi Japan 852-8501
109 Research Site Omura-shi Japan 856-8562
110 Research Site Sapporo-shi Japan 060-8648
111 Research Site Sasebo-shi Japan 857-1195
112 Research Site Sendai-shi Japan 980-8574
113 Research Site Shinjuku-ku Japan 160-8582
114 Research Site Daejeon Korea, Republic of 35015
115 Research Site Gwangju Korea, Republic of 61469
116 Research Site Jeju-si Korea, Republic of 690-767
117 Research Site Seoul Korea, Republic of 05030
118 Research Site Seoul Korea, Republic of 06591
119 Research Site Seoul Korea, Republic of 07345
120 Research Site Suwon-si Korea, Republic of 16499
121 Research Site Kaunas Lithuania LT-50009
122 Research Site Klaipeda Lithuania LT-92288
123 Research Site Chihuahua Mexico 31000
124 Research Site Leon Mexico 37000
125 Research Site Mexico D.F. Mexico 014080
126 Research Site Mexico Mexico 06700
127 Research Site Mérida Mexico 97000
128 Research Site San Luis Potosí Mexico 78213
129 Research Site Arequipa Peru 04000
130 Research Site Lima Peru 15023
131 Research Site Lima Peru 15033
132 Research Site Lima Peru 15046
133 Research Site Lima Peru 15073
134 Research Site Lima Peru 15102
135 Research Site Bialystok Poland 15-297
136 Research Site Bydgoszcz Poland 85 168
137 Research Site Koscian Poland 64-000
138 Research Site Kraków Poland 31-011
139 Research Site Lublin Poland 20-607
140 Research Site Nadarzyn Poland 05-830
141 Research Site Starachowice Poland 27-200
142 Research Site Szczecin Poland 71-252
143 Research Site Ustron Poland 43-450
144 Research Site Warszawa Poland 02-118
145 Research Site Brasov Romania 500283
146 Research Site Bucuresti Romania 011172
147 Research Site Cluj Napoca Romania 400006
148 Research Site Galati Romania 800578
149 Research Site Targu Mures Romania 540136
150 Research Site Smolensk Russian Federation 214015
151 Research Site Tolyatti Russian Federation 445039
152 Research Site Vladimir Russian Federation 600023
153 Research Site Yaroslavl Russian Federation 150003
154 Research Site Cape Town South Africa 7500
155 Research Site Johannesburg South Africa 2021
156 Research Site Stellenbosch South Africa 7600
157 Research Site Barcelona Spain 08035
158 Research Site Getafe Spain 28905
159 Research Site Mérida Spain 06800
160 Research Site Servilla Spain 41014
161 Research Site Vigo Spain 36200
162 Research Site Kaohsiung Taiwan 83301
163 Research Site Taichung Taiwan 40705
164 Research Site Taipei Taiwan 10002
165 Research Site Kyiv Ukraine 01601
166 Research Site Kyiv Ukraine 03680
167 Research Site Lviv Ukraine 79011
168 Research Site Ternopil Ukraine 46001
169 Research Site Uzhhorod Ukraine 88018
170 Research Site Vinnytsia Ukraine 21018
171 Research Site Zaporizhzhia Ukraine 69600
172 Research Site Doncaster United Kingdom DN2 5LT
173 Research Site Leeds United Kingdom LS7 4SA
174 Research Site London United Kingdom SE1 9RT
175 Research Site Manchester United Kingdom M13 9WL

Sponsors and Collaborators

  • AstraZeneca
  • PRA Health Sciences

Investigators

  • Principal Investigator: Kenneth Kalunian, MD, University of California, San Diego
  • Study Director: Raj Tummala, MD, AstraZeneca

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT02794285
Other Study ID Numbers:
  • D3461C00009
First Posted:
Jun 9, 2016
Last Update Posted:
Jan 25, 2022
Last Verified:
Jan 1, 2022
Keywords provided by AstraZeneca
Lupus Erythematosus, Systemic Autoimmune Diseases, Connective Tissue Diseases,Immune System Diseases
Additional relevant MeSH terms:
Lupus Erythematosus, Systemic

Study Results

No Results Posted as of Jan 25, 2022