Clinical trials: sponsored by Kyowa Kirin Co., Ltd.
Aplastic Anemia
Long Term Follow-up Observational Study After Clinical Trials of AMG531 (Romiplostim) in Patients With Untreated Aplastic Anemia
To evaluate the long-term efficacy and safety after the end of romiplostim treatment by observation [up to 5 years] of patients who were registered for Study 531-003/531-004 in immunosuppressive therapy-naïve patients with…
- Trial name
- NCT04870346
- Where
- Japan
- Volunteers
- 36 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Advanced Solid Tumor, Metastatic Solid Tumor
A Study of KK2269 in Adult Participants With Solid Tumors
This is a first-in-human study of KK2269. Part 1 and Part 2 will be conducted as a multicenter, open-label, non-randomized, dose-escalation study.
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- Trial name
- NCT06266299
- Testing
- KK2269, Docetaxel
- Where
- 32 sites in United States, Japan
- Volunteers
- 83 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Diabetic Macular Edema (DME)
Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema
The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with DME.
- Trial name
- NCT06116916
- Testing
- KHK4951, Aflibercept Injection
- Where
- 87 sites in United States, Australia and 2 more
- Volunteers
- 185 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Neovascular Age-Related Macular Degeneration (nAMD)
Study to Assess the Efficacy & Safety of KHK4951 in Patients With Neovascular Age-Related Macular Degeneration
The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with nAMD.
- Trial name
- NCT06116890
- Testing
- KHK4951, Aflibercept Injection
- Where
- 84 sites in United States, Australia and 2 more
- Volunteers
- 170 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Achondroplasia
Evaluate the Efficacy and Safety of KK8398 in Patients With Achondroplasia（AOBA Study）
This trial will evaluate the efficacy of KK8398 on annualized height velocity after 52 weeks of repeated administration of KK8398 to patients with achondroplasia
- Trial name
- NCT06926491
- Testing
- KK8398
- Where
- 9 sites in Japan
- Volunteers
- 13 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Indolent B-cell Non-Hodgkin's Lymphoma
Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL)
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ME-401 in the treatment of Japanese participants with Relapsed or Refractory indolent B-Cell Non-Hodgkin's Lymphoma.
- Trial name
- NCT04533581
- Testing
- ME-401
- Where
- 30 sites in Japan
- Volunteers
- 61 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Healthy Volunteers, Systemic Lupus Erythematosus (SLE)
A Study of KK4277 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus
Part 1 : To evaluate the safety and tolerability of a single intravenous (IV) or subcutaneous (SC) dose of KK4277 in healthy Japanese or non-Asian adult males.
- Conditions
- Healthy Volunteers, Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
- Trial name
- NCT05411016
- Testing
- KK4277
- Where
- 23 sites in Japan, South Korea
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Kyowa Kirin Co., Ltd.
X-linked Hypophosphatemia
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
A first-in-human study of KK8123 in adults with X-linked hypophosphatemia.
- Trial name
- NCT06525636
- Testing
- KK8123
- Where
- 10 sites in United States, Canada and 3 more
- Volunteers
- 39 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Hematologic Neoplasms
A Phase 1/2 Study of KK2430 in Participants With Hematologic Neoplasms
KK2430 ("Study Drug") as a potential treatment for people with Hematologic Neoplasms. KK2430 is an experimental drug; it has not been approved for the treatment of any disease by health authorities such as United States Food and…
- Trial name
- NCT07629726
- Testing
- KK2430
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Healthy Volunteers Essential Hypertension
Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension
Part 1 : To evaluate the safety of single-dose KK3910 in healthy volunteers. Part 2 : To evaluate the safety of multiple-dose KK3910 in patients with essential hypertension.
- Trial name
- NCT06823947
- Testing
- KK3910
- Where
- 3 sites in Japan
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Kyowa Kirin Co., Ltd.
Relapsed or Refractory AML and Other Hematologic Malignancies
Phase I Clinical Trial of KK2845 in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Other Hematologic Malignancies.
This is the first in human study of KK2845. This clinical trial consists of Part 1 (Dose Escalation) and Part 2 (Backfill). For patients with relapsed or refractory acute myeloid leukemia (AML) and other Hematologic Malignancies…
- Trial name
- NCT06812104
- Testing
- KK2845_1, KK2845_2, KK2845_3
- Where
- 17 sites in Japan
- Volunteers
- 156 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Acute Myeloid Leukemia (AML)
A Phase 2 Clinical Study of Ziftomenib in Patients With Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia
This is the first study to administer ziftomenib to Japanese patients. In this study, the efficacy, safety, and pharmacokinetics of ziftomenib will be evaluated in patients with relapsed or refractory NPM1-mutated acute myeloid…
- Trial name
- NCT07623616
- Testing
- ziftomenib
- Where
- 20 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Advanced or Metastatic Solid Tumors
A Clinical Study of KK2260 in Patients With Advanced or Metastatic Solid Tumors
This is the first in human study of KK2260. In Part 1a, the maximum tolerated dose (MTD) will be determined while evaluating the safety and tolerability of KK2260 in patients with advanced or metastatic solid tumors (any cancer…
- Trial name
- NCT06248411
- Testing
- KK2260
- Where
- 14 sites in Japan
- Volunteers
- 189 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma
Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ME-401 in the treatment of Japanese participants with Relapsed or Refractory indolent B-Cell Non-Hodgkin's Lymphoma and to continue…
- Trial name
- NCT03985189
- Testing
- ME-401
- Where
- 9 sites in Japan
- Volunteers
- 14 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Mycosis Fungoides, Sezary Syndrome
Assessment of Safety and Efficacy of Poteligeo Inj. 20 mg (Mogamulizumab) Through Use-result Surveillance
The purpose of this surveillance is to assess the safety and efficacy of Poteligeo Inj. 20 mg (mogamulizumab) in routine clinical settings.
- Trial name
- NCT07132567
- Testing
- Poteligeo 20mg
- Where
- 6 sites in South Korea
- Volunteers
- 15 people
- Sponsor
- Kyowa Kirin Co., Ltd.
X-Linked Hypophosphatemia
Study of Longitudinal Observation for Patient With X-linked Hypophosphatemic Rickets/Osteomalacia in Collaboration With Asian Partners
Through observation of patients with X-linked hypophosphatemic rickets/osteomalacia (XLH) for up to 10 years, the study intends to collect data that allow achievement of the following objectives: 1.
- Trial name
- SUNFLOWER (NCT03745521)
- Testing
- no intervention
- Where
- Japan
- Volunteers
- 226 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Systemic Sclerosis
A Study of KHK4827 in Patients With Systemic Sclerosis
Exploratory evaluation of pharmacokinetics and safety of KHK4827 in subjects with systemic sclerosis
- Trial name
- NCT04368403
- Testing
- KHK4827
- Where
- Japan
- Volunteers
- 8 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Moderate to Severe Systemic Sclerosis
A Phase 3 Study of KHK4827 in Patients With Systemic Sclerosis
To evaluate the efficacy and safety of KHK4827 in patients with systemic sclerosis who have moderate to severe skin thickening
- Trial name
- NCT03957681
- Testing
- KHK4827
- Where
- 6 sites in Japan
- Volunteers
- 100 people
- Sponsor
- Kyowa Kirin Co., Ltd.
X-linked Hypophosphatemia, Tumor-Induced Osteomalacia
Expanded Access to Burosumab
Individual patient expanded access requests may be considered for patients who have no other treatment options
- Trial name
- NCT03775187
- Testing
- Burosumab
- Sponsor
- Kyowa Kirin Co., Ltd.
Congenital Antithrombin Deficiency
A Study of KW-3357 in Congenital Antithrombin Deficiency
The aim of this study is to determine the pharmacokinetics, safety and tolerability of KW-3357 in asymptomatic subjects with congenital antithrombin deficiency.
- Trial name
- NCT00938288
- Testing
- KW-3357
- Where
- 8 sites in Germany, Sweden and 1 more
- Volunteers
- 16 people
- Sponsor
- Kyowa Kirin Co., Ltd.