Study of Evobrutinib in Participants With RMS (evolutionRMS 2)
Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04338061
Collaborator
EMD Serono Research & Development Institute, Inc. (Industry)
898
268
2
71.8
3.4
0
Study Details
Study Description
Brief Summary
The study is to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Teriflunomide (Aubagio®), administered orally once daily in participants with Relapsing Multiple Sclerosis (RMS).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
898 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With Teriflunomide, in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety (evolutionRMS 2)
Actual Study Start Date
:
Jul 2, 2020
Anticipated Primary Completion Date
:
Sep 4, 2023
Anticipated Study Completion Date
:
Jun 26, 2026
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Evobrutinib + Teriflunomide matched Placebo: DB Period
|
Drug: Evobrutinib
Evobrutinib twice daily (BID) in double-blind (DB) treatment period.
Other Names:
Drug: Placebo (match to Teriflunomide)
Placebo match to Teriflunomide once daily in double-blind treatment period.
|
| Active Comparator: Teriflunomide + Evobrutinib matched Placebo: DB Period
|
Drug: Teriflunomide
Teriflunomide once daily in double-blind treatment period.
Drug: Placebo (match to Evobrutinib)
Placebo match to Evobrutinib BID in double-blind treatment period.
|
Outcome Measures
Primary Outcome Measures
- Annualized Relapse Rate (ARR) [Up to 156 weeks]
The annualized relapse rates over 96 weeks will be calculated based on qualified relapses. Qualifying relapse is defined as occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis (MS) (for more than 24 hours, no fever, infection, injury, adverse events, and preceded by a stable or improving neurological state for greater than or equal to (=>) 30 days).
Secondary Outcome Measures
- Time to First Occurrence of 12-Week Confirmed Expanded Disability Status Scale (EDSS) Progression [Up to 156 weeks]
- Time to First Occurrence of 24-Week Confirmed Expanded Disability Status Scale (EDSS) Progression [Up to 156 weeks]
- Time to First Occurrence of 24-Weeks Confirmed Expanded Disability Status Scale (EDSS) Improvement [Up to 156 weeks]
- Change from Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) MS Physical Function (PF) Short Form Score [Baseline up to 96 weeks]
- Change from Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) MS Fatigue Short Form Score [Baseline up to 96 weeks]
- Total Number of Gadolinium-Enhancing (Gd+) T1 Lesions Assessed by all Available Magnetic Resonance Imaging (MRI) Scans [Up to Week 156]
- Total Number of New or Enlarging T2 Lesions Assessed by the Last Available Magnetic Resonance Imaging (MRI) Scan [Up to Week 156]
- Neurofilament light chain (NfL) Serum Concentration [At Week 12]
- Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs) [Baseline up to 156 weeks]
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal relationship with this treatment.
- Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and Electrocardiogram Findings [Baseline up to 156 weeks]
Number of participants with clinically significant change from baseline in vital signs, laboratory parameters and electrocardiogram findings will be reported.
- Absolute Concentrations of Immunoglobulin (Ig) Levels [Baseline up to 156 weeks]
- Change From Baseline in Immunoglobulin (Ig) Levels [Baseline up to 156 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Participants are diagnosed with RMS (relapsing-remitting multiple sclerosis [RRMS] or secondary progressive multiple sclerosis [SPMS] with relapses) in accordance with 2017 Revised McDonald criteria (Thompson 2018)
-
Participants with one or more documented relapses within the 2 years before Screening with either: a. one relapse which occurred within the last year prior to randomization, OR b. the presence of at least 1 gadolinium-enhancing (Gd+) T1 lesion within 6 months prior to randomization
-
Participants have Expanded Disability Status Scale (EDSS) score of 0 to 5.5 at Screening and Baseline (Day 1). Participants with an EDSS score <= 2 at Screening and Baseline (Day 1) are only eligible for participation if their disease duration (time since onset of symptoms) is no more than 10 years
-
Participants are neurologically stable for >= 30 days prior to both screening and baseline (Day 1)
-
Female participants must be neither pregnant nor breast-feeding or must lack child-bearing potential (as defined by either: post-menopausal or surgically sterile), or use an effective method of contraception for the duration of the study and at least 2 years after study intervention due to the long elimination period for teriflunomide of 2 years, unless the participant undergoes an accelerated elimination procedure
-
Male participants must refrain from donating sperm and/or abstain from intercourse with women of child-bearing potential or use an effective method of contraception for the duration of the study and at least 2 years after study intervention due to the long elimination period for teriflunomide of 2 years, unless the participant undergoes an accelerated elimination procedure
-
Participants have given written informed consent prior to any study-related procedure
-
Other protocol defined inclusion criteria could apply.
Exclusion Criteria:
- Participants diagnosed with Progressive MS, in accordance with the 2017 Revised McDonald criteria as follows: a). Participants with Primary Progressive MS. b).
Participants with secondary progressive MS without evidence of relapse
-
Disease duration more than (>) 10 years in participants with an EDSS =< 2.0 at screening
-
Immunologic disorder other than MS, or any other condition requiring oral, intravenous (IV) , intramuscular, or intra-articular corticosteroid therapy, with the exception of well-controlled Type 2 diabetes mellitus or well controlled thyroid disease
-
Other protocol defined exclusion criteria could apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site 752 | Cullman | Alabama | United States | 35058 |
| 2 | Research Site 741 | Scottsdale | Arizona | United States | 85258 |
| 3 | Research Site 704 | Tucson | Arizona | United States | 85710 |
| 4 | Research Site 751 | Hanford | California | United States | 93230 |
| 5 | Research Site 737 | West Hollywood | California | United States | 90048 |
| 6 | Research Site 759 | Colorado Springs | Colorado | United States | 80907 |
| 7 | Research Site 725 | Fort Collins | Colorado | United States | 80528 |
| 8 | Research Site 746 | Altamonte Springs | Florida | United States | 32714 |
| 9 | Research Site 718 | Jacksonville | Florida | United States | 32209 |
| 10 | Research Site 702 | Naples | Florida | United States | 34105 |
| 11 | Research Site 740 | Orlando | Florida | United States | 32806 |
| 12 | Research Site 726 | Port Charlotte | Florida | United States | 33952 |
| 13 | Research Site 719 | Sarasota | Florida | United States | 34243 |
| 14 | Research Site 743 | Tampa | Florida | United States | 33612 |
| 15 | Research Site 707 | Tampa | Florida | United States | 33634 |
| 16 | Research Site 732 | Vero Beach | Florida | United States | 32960 |
| 17 | Research Site 705 | Weeki Wachee | Florida | United States | 34607 |
| 18 | Research Site 753 | West Palm Beach | Florida | United States | 33407 |
| 19 | Research Site 742 | Honolulu | Hawaii | United States | 96817 |
| 20 | Research Site 715 | Evanston | Illinois | United States | 60201 |
| 21 | Research Site 714 | Fort Wayne | Indiana | United States | 46804 |
| 22 | Research Site 744 | Lafayette | Indiana | United States | 47904 |
| 23 | Research Site 717 | Overland Park | Kansas | United States | 66212 |
| 24 | Research Site 735 | Nicholasville | Kentucky | United States | 40356 |
| 25 | Research Site 706 | Scarborough | Maine | United States | 04074 |
| 26 | Research Site 738 | Detroit | Michigan | United States | 48202 |
| 27 | Research Site 723 | Saint Louis | Missouri | United States | 63128 |
| 28 | Research Site 724 | Amherst | New York | United States | 14226 |
| 29 | Research Site 736 | Asheville | North Carolina | United States | 28006 |
| 30 | Research Site 712 | Chapel Hill | North Carolina | United States | 27599 |
| 31 | Research Site 730 | Raleigh | North Carolina | United States | 27607 |
| 32 | Research Site 728 | Winston-Salem | North Carolina | United States | 27157 |
| 33 | Research Site 711 | Canton | Ohio | United States | 44735 |
| 34 | Research Site 757 | Columbus | Ohio | United States | 43214 |
| 35 | Research Site 734 | Dayton | Ohio | United States | 45459 |
| 36 | Research Site 748 | Philadelphia | Pennsylvania | United States | 19107 |
| 37 | Research Site 703 | San Antonio | Texas | United States | 78258 |
| 38 | Research Site 721 | Norfolk | Virginia | United States | 23502 |
| 39 | Research Site 144 | Gomel | Belarus | ||
| 40 | Research Site 143 | Grodno | Belarus | ||
| 41 | Research Site 142 | Minsk | Belarus | ||
| 42 | Research Site 141 | Vitebsk | Belarus | ||
| 43 | Research Site 145 | Vitebsk | Belarus | ||
| 44 | Research Site 603 | Belo Horizonte | Brazil | ||
| 45 | Research Site 599 | Curitiba | Brazil | ||
| 46 | Research Site 604 | Goiânia | Brazil | ||
| 47 | Research Site 600 | Joinville | Brazil | ||
| 48 | Research Site 614 | Passo Fundo | Brazil | ||
| 49 | Research Site 591 | Porto Alegre | Brazil | ||
| 50 | Research Site 594 | Porto Alegre | Brazil | ||
| 51 | Research Site 596 | Porto Alegre | Brazil | ||
| 52 | Research Site 609 | Vitória | Brazil | ||
| 53 | Research Site 155 | Blagoevgrad | Bulgaria | ||
| 54 | Research Site 156 | Dupnitsa | Bulgaria | ||
| 55 | Research Site 157 | Pleven | Bulgaria | ||
| 56 | Research Site 151 | Sofia | Bulgaria | ||
| 57 | Research Site 152 | Sofia | Bulgaria | ||
| 58 | Research Site 153 | Sofia | Bulgaria | ||
| 59 | Research Site 158 | Sofia | Bulgaria | ||
| 60 | Research Site 159 | Sofia | Bulgaria | ||
| 61 | Research Site 160 | Sofia | Bulgaria | ||
| 62 | Research Site 154 | Veliko Tarnovo | Bulgaria | ||
| 63 | Research Site 106 | Burnaby | Canada | ||
| 64 | Research Site 107 | London | Canada | ||
| 65 | Research site 105 | Montreal | Canada | ||
| 66 | Research Site 101 | Ottawa | Canada | ||
| 67 | Research Site 455 | Bordeaux Cedex | France | ||
| 68 | Research Site 459 | Brest cedex 2 | France | ||
| 69 | Reserach Site 451 | Clermont Ferrand Cedex | France | ||
| 70 | Research Site 458 | Limoges cedex | France | ||
| 71 | Research Site 456 | Nimes | France | ||
| 72 | Research Site 453 | Paris | France | ||
| 73 | Research Site 457 | Pringy cedex | France | ||
| 74 | Research Site 452 | Strasbourg cedex | France | ||
| 75 | Research Site 454 | Tours cedex 9 | France | ||
| 76 | Research Site 172 | Augsburg | Germany | ||
| 77 | Research Site 177 | Berlin | Germany | ||
| 78 | Research Site 180 | Berlin | Germany | ||
| 79 | Research Site 178 | Bonn | Germany | ||
| 80 | Research Site 184 | Dresden | Germany | ||
| 81 | Research Site 174 | Hamburg | Germany | ||
| 82 | Research Site 182 | Heidelberg | Germany | ||
| 83 | Research Site 179 | Koeln | Germany | ||
| 84 | Research Site 181 | Leipzig | Germany | ||
| 85 | Research Site 173 | Mainz | Germany | ||
| 86 | Research Site 176 | Minden | Germany | ||
| 87 | Research Site 171 | Regensburg | Germany | ||
| 88 | Research Site 183 | Rostock | Germany | ||
| 89 | Research Site 175 | Tuebingen | Germany | ||
| 90 | Research Site 272 | Łódź | Germany | ||
| 91 | Research Site 194 | Athens | Greece | ||
| 92 | Research Site 196 | Athens | Greece | ||
| 93 | Research Site 197 | Athens | Greece | ||
| 94 | Research Site 201 | Athens | Greece | ||
| 95 | Research Site 202 | Athens | Greece | ||
| 96 | Research Site 205 | Athens | Greece | ||
| 97 | Research Site 207 | Athens | Greece | ||
| 98 | Reserach Site 206 | Athens | Greece | ||
| 99 | Research Site 198 | Heraklion | Greece | ||
| 100 | Research Site 204 | Ioannina | Greece | ||
| 101 | Research Site 192 | Larissa | Greece | ||
| 102 | Research Site 199 | Marousi | Greece | ||
| 103 | Research Site 191 | Patras | Greece | ||
| 104 | Research Site 203 | Patra | Greece | ||
| 105 | Research Site 195 | Thessaloniki | Greece | ||
| 106 | Research Site 445 | Ahmedabad | India | ||
| 107 | Research Site 444 | Bangalore | India | ||
| 108 | Research Site 443 | Mangalore | India | ||
| 109 | Research Site 442 | New Delhi | India | ||
| 110 | Research Site 218 | Bari | Italy | ||
| 111 | Research Site 216 | Catania | Italy | ||
| 112 | Research Site 214 | Cefalù | Italy | ||
| 113 | Research Site 219 | Firenze | Italy | ||
| 114 | Research Site 221 | Milano | Italy | ||
| 115 | Research Site 211 | Napoli | Italy | ||
| 116 | Research Site 215 | Napoli | Italy | ||
| 117 | Research Site 220 | Orbassano | Italy | ||
| 118 | Research Site 217 | Palermo | Italy | ||
| 119 | Research Site 212 | Pozzilli | Italy | ||
| 120 | Research Site 213 | Roma | Italy | ||
| 121 | Research Site 222 | Roma | Italy | ||
| 122 | Research Site 231 | Riga | Latvia | ||
| 123 | Research Site 232 | Riga | Latvia | ||
| 124 | Research Site 233 | Riga | Latvia | ||
| 125 | Research site 241 | Kaunas | Lithuania | ||
| 126 | Research site 244 | Klaipeda | Lithuania | ||
| 127 | Research site 243 | Siauliai | Lithuania | ||
| 128 | Research site 242 | Vilnius | Lithuania | ||
| 129 | Research Site 551 | Kuala Lumpur | Malaysia | ||
| 130 | Research Site 554 | Kuala Lumpur | Malaysia | ||
| 131 | Research Site 556 | Kuala Lumpur | Malaysia | ||
| 132 | Research Site 552 | Kuching | Malaysia | ||
| 133 | Research Site 553 | Seberang Jaya | Malaysia | ||
| 134 | Research Site 251 | Chisinau | Moldova, Republic of | ||
| 135 | Research Site 252 | Chisinau | Moldova, Republic of | ||
| 136 | Research Site 481 | Bergen | Norway | ||
| 137 | Research site 483 | Drammen | Norway | ||
| 138 | Research Site 482 | Namsos | Norway | ||
| 139 | Research Site 562 | Baguio City | Philippines | ||
| 140 | Research Site 561 | Cebu City | Philippines | ||
| 141 | Reserach Site 267 | Bydgoszcz | Poland | ||
| 142 | Reserach Site 268 | Bydgoszcz | Poland | ||
| 143 | Research Site 273 | Katowice | Poland | ||
| 144 | Research Site 276 | Krakow | Poland | ||
| 145 | Research Site 263 | Lodz | Poland | ||
| 146 | Research Site 266 | Nowa Sol | Poland | ||
| 147 | Research Site 270 | Poznan | Poland | ||
| 148 | Research Site 262 | Rzeszow | Poland | ||
| 149 | Research Site 265 | Siemianowice | Poland | ||
| 150 | Research Site 271 | Szczecin | Poland | ||
| 151 | Research Site 264 | Warszawa | Poland | ||
| 152 | Research Site 277 | Warszawa | Poland | ||
| 153 | Reserach Site 275 | Warszawa | Poland | ||
| 154 | Research Site 269 | Wroclaw | Poland | ||
| 155 | Research Site 261 | Zabrze | Poland | ||
| 156 | Research Site 278 | Zamosc | Poland | ||
| 157 | Research Site 293 | Aveiro | Portugal | ||
| 158 | Research Site 282 | Braga | Portugal | ||
| 159 | Research Site 289 | Coimbra | Portugal | ||
| 160 | Research Site 281 | Lisboa | Portugal | ||
| 161 | Research Site 283 | Lisboa | Portugal | ||
| 162 | Research Site 287 | Lisboa | Portugal | ||
| 163 | Research SIte 284 | Matosinhos | Portugal | ||
| 164 | Research Site 292 | Porto | Portugal | ||
| 165 | Research Site 288 | Pragal | Portugal | ||
| 166 | Research Site 291 | Santa Maria da Feira | Portugal | ||
| 167 | Research Site 286 | Torres Vedras | Portugal | ||
| 168 | Research Site 791 | Guaynabo | Puerto Rico | ||
| 169 | Research Site 314 | Brasov | Romania | ||
| 170 | Research Site 307 | București | Romania | ||
| 171 | Research Site 309 | Caracal | Romania | ||
| 172 | Research Site 302 | Targu Mures | Romania | ||
| 173 | Research Site 325 | Kazan | Russian Federation | ||
| 174 | Research Site 329 | Kazan | Russian Federation | ||
| 175 | Research Site 323 | Kemerovo | Russian Federation | ||
| 176 | Research Site 344 | Kirov | Russian Federation | ||
| 177 | Research Site 340 | Krasnodar | Russian Federation | ||
| 178 | Research Site 334 | Krasnoyarsk | Russian Federation | ||
| 179 | Research Site 341 | Moscow | Russian Federation | ||
| 180 | Research Site 343 | Moscow | Russian Federation | ||
| 181 | Research Site 345 | Moscow | Russian Federation | ||
| 182 | Research Site 332 | Nizhniy Novgorod | Russian Federation | ||
| 183 | Research Site 327 | Novosibirsk | Russian Federation | ||
| 184 | Research Site 330 | Novosibirsk | Russian Federation | ||
| 185 | Research Site 331 | Novosibirsk | Russian Federation | ||
| 186 | Research Site 335 | Novosibirsk | Russian Federation | ||
| 187 | Research Site 328 | Rostov-on-Don | Russian Federation | ||
| 188 | Research Site 346 | Saint Petersburg | Russian Federation | ||
| 189 | Research Site 324 | Saint-Petersburg | Russian Federation | ||
| 190 | Research Site 338 | Saint-Petersburg | Russian Federation | ||
| 191 | Research Site 339 | Saint-Petersburg | Russian Federation | ||
| 192 | Research Site 342 | Saint-Petersburg | Russian Federation | ||
| 193 | Research Site 326 | Saransk | Russian Federation | ||
| 194 | Research Site 321 | Sestroretsk | Russian Federation | ||
| 195 | Research Site 337 | Tyumen | Russian Federation | ||
| 196 | Research Site 571 | Singapore | Singapore | ||
| 197 | Research Site 351 | Banska Bystrica | Slovakia | ||
| 198 | Research Site 352 | Bratislava | Slovakia | ||
| 199 | Research Site 353 | Bratislava | Slovakia | ||
| 200 | Research Site 354 | Bratislava | Slovakia | ||
| 201 | Research Site 356 | Bratislava | Slovakia | ||
| 202 | Research Site 359 | Dubnica nad Vahom | Slovakia | ||
| 203 | Research Site 358 | Trencin | Slovakia | ||
| 204 | Research Site 357 | Trnava | Slovakia | ||
| 205 | Research Site 373 | Celje | Slovenia | ||
| 206 | Research Site 372 | Ljubljana | Slovenia | ||
| 207 | Research Site 371 | Maribor | Slovenia | ||
| 208 | Research Site 501 | Cape Town | South Africa | ||
| 209 | Research Site 502 | Cape Town | South Africa | ||
| 210 | Research Site 503 | Cape Town | South Africa | ||
| 211 | Research Site 504 | Pretoria | South Africa | ||
| 212 | Research Site 384 | Alcoron | Spain | ||
| 213 | Research Site 391 | Barakaldo | Spain | ||
| 214 | Research Site 390 | Barcelona | Spain | ||
| 215 | Research Site 382 | Cordoba | Spain | ||
| 216 | Research Site 389 | El Palmar | Spain | ||
| 217 | Research Site 388 | Madrid | Spain | ||
| 218 | Research Site 392 | Majadahonda | Spain | ||
| 219 | Research Site 383 | Malaga | Spain | ||
| 220 | Research Site 387 | Sevilla | Spain | ||
| 221 | Research Site 385 | Valencia | Spain | ||
| 222 | Research Site 386 | Valencia | Spain | ||
| 223 | Research Site 381 | Vigo | Spain | ||
| 224 | Research Site 512 | Göteborg | Sweden | ||
| 225 | Research site 514 | Malmö | Sweden | ||
| 226 | Research Site 511 | Stockholm | Sweden | ||
| 227 | Research Site 513 | Uppsala | Sweden | ||
| 228 | Research Site 404 | Aarau | Switzerland | ||
| 229 | Research Site 402 | Bern | Switzerland | ||
| 230 | Research Site 403 | Lugano | Switzerland | ||
| 231 | Research Site 583 | Bangkoknoi | Thailand | ||
| 232 | Research Site 582 | Muang | Thailand | ||
| 233 | Research Site 538 | Ankara | Turkey | ||
| 234 | Research Site 544 | Ankara | Turkey | ||
| 235 | Research Site 531 | Istanbul | Turkey | ||
| 236 | Research Site 534 | Istanbul | Turkey | ||
| 237 | Research Site 536 | Istanbul | Turkey | ||
| 238 | Research Site 541 | Istanbul | Turkey | ||
| 239 | Research Site 543 | Istanbul | Turkey | ||
| 240 | Research Site 539 | Izmir | Turkey | ||
| 241 | Research Site 533 | Kocaeli | Turkey | ||
| 242 | Research Site 537 | Konya | Turkey | ||
| 243 | Research Site 540 | Mersin | Turkey | ||
| 244 | Research Site 535 | Samsun | Turkey | ||
| 245 | Research Site 532 | Trabzon | Turkey | ||
| 246 | Research Site 415 | Chernihiv | Ukraine | ||
| 247 | Research Site 417 | Chernihiv | Ukraine | ||
| 248 | Research Site 414 | Dnipro | Ukraine | ||
| 249 | Research Site 416 | Dnipro | Ukraine | ||
| 250 | Research Site 420 | Dnipro | Ukraine | ||
| 251 | Research Site 413 | Ivano-Frankivsk | Ukraine | ||
| 252 | Research Site 624 | Kharkiv | Ukraine | ||
| 253 | Research Site 632 | Kharkiv | Ukraine | ||
| 254 | Research Site 633 | Kharkiv | Ukraine | ||
| 255 | Research Site 419 | Kherson | Ukraine | ||
| 256 | Research Site 411 | Kyiv | Ukraine | ||
| 257 | Research Site 418 | Kyiv | Ukraine | ||
| 258 | Research Site 629 | Lutsk | Ukraine | ||
| 259 | Research Site 627 | Lviv | Ukraine | ||
| 260 | Research Site 622 | Poltava | Ukraine | ||
| 261 | Research Site 625 | Rivne | Ukraine | ||
| 262 | Research Site 628 | Ternopil | Ukraine | ||
| 263 | Research Site 630 | Uzhgorod | Ukraine | ||
| 264 | Research Site 623 | Vinnytsia | Ukraine | ||
| 265 | Research Site 412 | Zaporizhzhia | Ukraine | ||
| 266 | Research Site 621 | Zaporizhzhia | Ukraine | ||
| 267 | Research Site 631 | Zaporizhzhia | Ukraine | ||
| 268 | Research Site 626 | Zhytomyr | Ukraine |
Sponsors and Collaborators
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- EMD Serono Research & Development Institute, Inc.
Investigators
- Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Trial Awareness and Transparency website
- US Medical Information website, Medical Resources
- evolutionRMS recruitment website (applicable for US residents only)
Publications
None provided.Responsible Party:
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier:
NCT04338061
Other Study ID Numbers:
- MS200527_0082
- 2019-004980-36
First Posted:
Apr 8, 2020
Last Update Posted:
Jul 1, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Additional relevant MeSH terms: