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17 Trials

   

Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Simlandi (adalimumab-ryvk) / Cipla, Alvotech, Stada, Teva, JAMP Pharma, YAS Holding
2017-003367-35: A Multicenter, Double-blind, Randomized, Parallel-group, Active Control Study to Compare the Efficacy, Safety, and Immunogenicity of AVT02 Versus Humira® in Patients with Moderate-to-Severe Chronic Plaque Psoriasis (ALVOPAD PS)

Not yet recruiting
3
400
Europe
adalimumab, Humira, AVT02, Solution for injection in pre-filled syringe, Humira
Alvotech Swiss AG, Alvotech Swiss AG
Chronic Plaque Psoriasis, Chronic Plaque Psoriasis, Diseases [C] - Immune System Diseases [C20]
 
 
2019-002911-25: Multicenter, Double-blind, Randomized, Parallel-group, Study Evaluating Pharmacokinetic, Efficacy, Safety, and Immunogenicity Between Patients with Moderate to Severe Chronic Plaque Psoriasis Receiving Humira® and Patients Undergoing Repeated Switches Between Humira® and AVT02 Followed by a Safety Extension Phase of AVT02

Not yet recruiting
3
548
Europe
adalimumab, Humira, AVT02, Solution for injection in pre-filled syringe, Humira
Alvotech Swiss AG, Alvotech Swiss AG
Chronic Plaque Psoriasis, Chronic Plaque Psoriasis, Diseases [C] - Immune System Diseases [C20]
 
 
Selarsdi (ustekinumab-aekn) / Alvotech, Fuji Pharma, Cipla, Teva, Stada
2020-004493-22: A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Ustekinumab (AVT04) and Stelara® in Patients With Moderate to Severe Chronic Plaque-type Psoriasis Randomizowane, prowadzone metodą podwójnie ślepej próby, wieloośrodkowe badanie, mające na celu wykazanie równoważnej skuteczności oraz porównanie bezpieczeństwa stosowania i immunogenności biopodobnego ustekinumabu (AVT04) i produktu Stelara® u pacjentów z przewlekłą łuszczycą plackowatą o nasileniu od umiarkowanego do ciężkiego

Not yet recruiting
3
528
Europe
Ustekinumab, Stelara, AVT04, Solution for injection in pre-filled syringe, Stelara
Alvotech Swiss AG, Alvotech Swiss AG
Moderate to Severe Chronic Plaque-type Psoriasis, Moderate to Severe Chronic Plaque-type Psoriasis, Diseases [C] - Immune System Diseases [C20]
 
 
AVT06 (aflibercept low dose biosimilar) / Cipla, Alvotech, Stada, Fuji Pharma, Teva, Polifarma, Advanz Pharma, Servier
ALVOEYE, NCT05155293 / 2021-003651-42: Clinical Study to Compare Efficacy and Safety of AVT06 and EU-Eylea

Completed
3
413
Europe, Japan, RoW
AVT06 (proposed aflibercept biosimilar), Eylea® (Aflibercept)
Alvotech Swiss AG
Neovascular (Wet) AMD
11/23
09/24
ALVOEYE-D, NCT05986786: Clinical Study to Evaluate the Handling and Safety of AVT06 PFS in Subjects With Chorioretinal Vascular Disease

Active, not recruiting
3
35
RoW
Patients will receive 1 IVT injection of AVT06 PFS depending on their chorioretinal vascular disease schedule
Alvotech Swiss AG
Chorioretinal Vascular Disease
04/24
04/25
AVT03 (denosumab biosimilar) / Alvotech, Dr. Reddy’s
2021-005071-40: A Randomized, Double-Blind, Parallel Design, Repeat Dose, 2-arm, Multicenter Study Comparing the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profiles of AVT03 and US-Prolia® in Postmenopausal Women with Osteoporosis, ALVOBOND Randomizované, dvojitě zaslepené, multicentrické klinické hodnocení sparalelním uspořádáním, opakovanými dávkami a dvěma rameny,porovnávající účinnost, bezpečnost, imunogenicitu a farmakokineticképrofily přípravku AVT03 a přípravku Prolia® (USA) u postmenopauzálníchžen s osteoporózou, ALVOBOND

Not yet recruiting
3
532
RoW
denosumab, Prolia, AVT03, Solution for injection in pre-filled syringe, Prolia
Alvotech Swiss AG, Alvotech Swiss AG
Osteoporosis, Osteoporosis, Diseases [C] - Musculoskeletal Diseases [C05]
 
 
ALVOBOND, NCT05395091 / 2021-005071-40: Multicenter Study in Postmenopausal Women with Osteoporosis,

Completed
3
532
Europe, RoW
AVT03, Denosumab, Prolia
Alvotech Swiss AG, Alvotech Swiss AG
Osteoporosis, Postmenopausal
05/24
10/24
NCT05126784: AVT03 With Prolia in Healthy Male Subjects

Completed
1
209
RoW
AVT03, AVT03, Biosimilar Denosumab, Prolia, Denosumab
Alvotech Swiss AG
Healthy Male Subjects
10/23
10/23
NCT05876949: AVT03 With Xgeva in Healthy Male Subjects

Completed
1
208
Europe, RoW
AVT03, AVT03 proposed Biosimilar to Denosumab, Denosumab, Xgeva
Alvotech Swiss AG
This is a Phase I Study Conducted in Healthy Volunteers
04/24
04/24
AVT23 (omalizumab biosimilar) / Kashiv Biosci, Alvotech, Advanz Pharma
NCT05774639: Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria

Completed
3
600
US, RoW
Omalizumab Injection, ADL-018, Xolair Prefilled Syringe
Kashiv BioSciences, LLC, COD Research Private Ltd
Chronic Idiopathic Urticaria
10/24
12/24
NCT05413161: To Compare the PK, PD, Safety & Immunogenicity of ADL-018 in Healthy Subjects

Completed
1
306
RoW
ADL-018, US-licensed XOLAIR, EU-Approved XOLAIR
Kashiv BioSciences, LLC
Healthy
02/23
06/23
NCT05564611: PK, PD, Safety & Immunogenicity of ADL-018 Lyo in Healthy Adult Subjects

Completed
1
204
RoW
Omalizumab 150mg, ADL-018
Kashiv BioSciences, LLC
Healthy
07/23
08/23
AVT05 (golimumab biosimilar) / Alvotech, Lupin, Teva
2022-001825-63: A Clinical Study to Investigate the Comparative Efficacy, Safety, and Immunogenicity Between Subcutaneous AVT05 and EU-approved Simponi® in Combination with Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis

Not yet recruiting
3
472
Europe, RoW
golimumab, Simponi, AVT05, Solution for injection in pre-filled syringe, Simponi
Alvotech Swiss AG, Alvotech Swiss AG
Rheumatoid Arthritis reumatoidiniu artritu, Rheumatoid Arthritis reumatoidiniu artritu, Diseases [C] - Immune System Diseases [C20]
 
 
ALVOFLEX, NCT05842213 / 2022-001825-63: Comparative, Multicenter Study in Subjects with Rheumatoid Arthritis,

Completed
3
502
Europe
AVT05 (proposed biosimilar to golimumab), Simponi (Golimumab)
Alvotech Swiss AG, Alvotech Swiss AG
Rheumatoid Arthritis
03/24
09/24
NCT05632211: A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi® in Healthy Adult Participants

Completed
1
336
Europe, RoW
AVT05, Simponi, Golimumab
Alvotech Swiss AG, Iqvia Pty Ltd
Healthy Adult Subjects
10/23
10/23
AVT16 (vedolizumab biosimilar) / Alvotech, JAMP Pharma, Advanz Pharma
NCT06570772: Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio

Recruiting
3
748
Europe, RoW
AVT16, AVT16 proposed biosimilar to vedolizumab, Vedolizumab, Entyvio
Alvotech Swiss AG
Ulcerative Colitis
03/26
08/26
NCT06400719: Pilot Study of AVT16 in Healthy Adult Subjects

Completed
1
18
RoW
AVT16
Alvotech Swiss AG
Healthy
11/24
11/24
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Simlandi (adalimumab-ryvk) / Cipla, Alvotech, Stada, Teva, JAMP Pharma, YAS Holding
2017-003367-35: A Multicenter, Double-blind, Randomized, Parallel-group, Active Control Study to Compare the Efficacy, Safety, and Immunogenicity of AVT02 Versus Humira® in Patients with Moderate-to-Severe Chronic Plaque Psoriasis (ALVOPAD PS)

Not yet recruiting
3
400
Europe
adalimumab, Humira, AVT02, Solution for injection in pre-filled syringe, Humira
Alvotech Swiss AG, Alvotech Swiss AG
Chronic Plaque Psoriasis, Chronic Plaque Psoriasis, Diseases [C] - Immune System Diseases [C20]
 
 
2019-002911-25: Multicenter, Double-blind, Randomized, Parallel-group, Study Evaluating Pharmacokinetic, Efficacy, Safety, and Immunogenicity Between Patients with Moderate to Severe Chronic Plaque Psoriasis Receiving Humira® and Patients Undergoing Repeated Switches Between Humira® and AVT02 Followed by a Safety Extension Phase of AVT02

Not yet recruiting
3
548
Europe
adalimumab, Humira, AVT02, Solution for injection in pre-filled syringe, Humira
Alvotech Swiss AG, Alvotech Swiss AG
Chronic Plaque Psoriasis, Chronic Plaque Psoriasis, Diseases [C] - Immune System Diseases [C20]
 
 
Selarsdi (ustekinumab-aekn) / Alvotech, Fuji Pharma, Cipla, Teva, Stada
2020-004493-22: A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Ustekinumab (AVT04) and Stelara® in Patients With Moderate to Severe Chronic Plaque-type Psoriasis Randomizowane, prowadzone metodą podwójnie ślepej próby, wieloośrodkowe badanie, mające na celu wykazanie równoważnej skuteczności oraz porównanie bezpieczeństwa stosowania i immunogenności biopodobnego ustekinumabu (AVT04) i produktu Stelara® u pacjentów z przewlekłą łuszczycą plackowatą o nasileniu od umiarkowanego do ciężkiego

Not yet recruiting
3
528
Europe
Ustekinumab, Stelara, AVT04, Solution for injection in pre-filled syringe, Stelara
Alvotech Swiss AG, Alvotech Swiss AG
Moderate to Severe Chronic Plaque-type Psoriasis, Moderate to Severe Chronic Plaque-type Psoriasis, Diseases [C] - Immune System Diseases [C20]
 
 
AVT06 (aflibercept low dose biosimilar) / Cipla, Alvotech, Stada, Fuji Pharma, Teva, Polifarma, Advanz Pharma, Servier
ALVOEYE, NCT05155293 / 2021-003651-42: Clinical Study to Compare Efficacy and Safety of AVT06 and EU-Eylea

Completed
3
413
Europe, Japan, RoW
AVT06 (proposed aflibercept biosimilar), Eylea® (Aflibercept)
Alvotech Swiss AG
Neovascular (Wet) AMD
11/23
09/24
ALVOEYE-D, NCT05986786: Clinical Study to Evaluate the Handling and Safety of AVT06 PFS in Subjects With Chorioretinal Vascular Disease

Active, not recruiting
3
35
RoW
Patients will receive 1 IVT injection of AVT06 PFS depending on their chorioretinal vascular disease schedule
Alvotech Swiss AG
Chorioretinal Vascular Disease
04/24
04/25
AVT03 (denosumab biosimilar) / Alvotech, Dr. Reddy’s
2021-005071-40: A Randomized, Double-Blind, Parallel Design, Repeat Dose, 2-arm, Multicenter Study Comparing the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profiles of AVT03 and US-Prolia® in Postmenopausal Women with Osteoporosis, ALVOBOND Randomizované, dvojitě zaslepené, multicentrické klinické hodnocení sparalelním uspořádáním, opakovanými dávkami a dvěma rameny,porovnávající účinnost, bezpečnost, imunogenicitu a farmakokineticképrofily přípravku AVT03 a přípravku Prolia® (USA) u postmenopauzálníchžen s osteoporózou, ALVOBOND

Not yet recruiting
3
532
RoW
denosumab, Prolia, AVT03, Solution for injection in pre-filled syringe, Prolia
Alvotech Swiss AG, Alvotech Swiss AG
Osteoporosis, Osteoporosis, Diseases [C] - Musculoskeletal Diseases [C05]
 
 
ALVOBOND, NCT05395091 / 2021-005071-40: Multicenter Study in Postmenopausal Women with Osteoporosis,

Completed
3
532
Europe, RoW
AVT03, Denosumab, Prolia
Alvotech Swiss AG, Alvotech Swiss AG
Osteoporosis, Postmenopausal
05/24
10/24
NCT05126784: AVT03 With Prolia in Healthy Male Subjects

Completed
1
209
RoW
AVT03, AVT03, Biosimilar Denosumab, Prolia, Denosumab
Alvotech Swiss AG
Healthy Male Subjects
10/23
10/23
NCT05876949: AVT03 With Xgeva in Healthy Male Subjects

Completed
1
208
Europe, RoW
AVT03, AVT03 proposed Biosimilar to Denosumab, Denosumab, Xgeva
Alvotech Swiss AG
This is a Phase I Study Conducted in Healthy Volunteers
04/24
04/24
AVT23 (omalizumab biosimilar) / Kashiv Biosci, Alvotech, Advanz Pharma
NCT05774639: Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria

Completed
3
600
US, RoW
Omalizumab Injection, ADL-018, Xolair Prefilled Syringe
Kashiv BioSciences, LLC, COD Research Private Ltd
Chronic Idiopathic Urticaria
10/24
12/24
NCT05413161: To Compare the PK, PD, Safety & Immunogenicity of ADL-018 in Healthy Subjects

Completed
1
306
RoW
ADL-018, US-licensed XOLAIR, EU-Approved XOLAIR
Kashiv BioSciences, LLC
Healthy
02/23
06/23
NCT05564611: PK, PD, Safety & Immunogenicity of ADL-018 Lyo in Healthy Adult Subjects

Completed
1
204
RoW
Omalizumab 150mg, ADL-018
Kashiv BioSciences, LLC
Healthy
07/23
08/23
AVT05 (golimumab biosimilar) / Alvotech, Lupin, Teva
2022-001825-63: A Clinical Study to Investigate the Comparative Efficacy, Safety, and Immunogenicity Between Subcutaneous AVT05 and EU-approved Simponi® in Combination with Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis

Not yet recruiting
3
472
Europe, RoW
golimumab, Simponi, AVT05, Solution for injection in pre-filled syringe, Simponi
Alvotech Swiss AG, Alvotech Swiss AG
Rheumatoid Arthritis reumatoidiniu artritu, Rheumatoid Arthritis reumatoidiniu artritu, Diseases [C] - Immune System Diseases [C20]
 
 
ALVOFLEX, NCT05842213 / 2022-001825-63: Comparative, Multicenter Study in Subjects with Rheumatoid Arthritis,

Completed
3
502
Europe
AVT05 (proposed biosimilar to golimumab), Simponi (Golimumab)
Alvotech Swiss AG, Alvotech Swiss AG
Rheumatoid Arthritis
03/24
09/24
NCT05632211: A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi® in Healthy Adult Participants

Completed
1
336
Europe, RoW
AVT05, Simponi, Golimumab
Alvotech Swiss AG, Iqvia Pty Ltd
Healthy Adult Subjects
10/23
10/23
AVT16 (vedolizumab biosimilar) / Alvotech, JAMP Pharma, Advanz Pharma
NCT06570772: Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio

Recruiting
3
748
Europe, RoW
AVT16, AVT16 proposed biosimilar to vedolizumab, Vedolizumab, Entyvio
Alvotech Swiss AG
Ulcerative Colitis
03/26
08/26
NCT06400719: Pilot Study of AVT16 in Healthy Adult Subjects

Completed
1
18
RoW
AVT16
Alvotech Swiss AG
Healthy
11/24
11/24

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