Clinical trials: Inadequate Response
Active Polyarticular Juvenile Idiopathic Arthritis
Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)
The purpose of this study is to estimate Abatacept steady-state trough concentration (Cmin) at Day 113 in children and adolescents with pJIA
- Trial name
- NCT01844518
- Testing
- Abatacept
- Where
- 57 sites in United States, Argentina and 10 more
- Volunteers
- 219 people
- Sponsor
- Bristol-Myers Squibb
Transfusion-dependent Hemachromatosis, Thalassemia Major
Pilot Study for Patients With Poor Response to Deferasirox
This purpose of this study is to understand the differences between people who have a good response to deferasirox (exjade) compared to people who have a poor response to this medication when used for transfusion-dependent iron…
- Conditions
- Transfusion-dependent Hemachromatosis, Thalassemia Major, Sickle Cell Disease
- Trial name
- NCT00749515
- Testing
- Deferoxamine, Deferasirox, HIDA
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Boston Children's Hospital
Chronic Spontaneous Urticaria
24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up
The purpose of this trial is: 1. to assess the efficacy, pharmacokinetics, and safety of remibrutinib vs. placebo in adolescents from 12 to < 18 years of age suffering from chronic spontaneous urticaria inadequately controlled by…
- Trial name
- NCT05677451
- Testing
- LOU064 (blinded)
- Where
- 49 sites in United States, Argentina and 15 more
- Volunteers
- 100 people
- Sponsor
- Novartis Pharmaceuticals
Atopic Dermatitis, Atopic Dermatitis, Unspecified
Real World Efficiency of Abrocitinib Treatment at Patients With Moderate to Severe Atopic Dermatitis Who Had Inadequate Response to Previous Biologic Therapies.
This is a prospective, multi-center observational study characterizing clinical and patient reported outcomes of patients receiving abrocitinib for moderate-to-severe atopic dermatitis (M2S AD) who had inadequate response (or…
- Conditions
- Atopic Dermatitis, Atopic Dermatitis, Unspecified, Dermatitis, Atopic
- Trial name
- NCT06899204
- Testing
- Abrocitinib
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Pfizer
Chronic Graft Versus Host Disease
A Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Belumosudil in Chinese Adolescents With cGVHD Who Have Had an Inadequate Response to Glucocorticoids or Other Systemic Therapies
This is a single group, Phase 4, single-arm post-marketing study for treatment. The purpose of this study is to verify the pharmacokinetics, efficacy, and safety of belumosudil mesylate tablets in Chinese adolescent participants…
- Trial name
- NCT06616415
- Testing
- Belumosudil
- Where
- 2 sites in China
- Volunteers
- 6 people
- Sponsor
- Sanofi
Ulcerative Colitis
Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With Moderately to Severely Active Ulcerative Colitis.
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).
- Trial name
- U-ASTOUND (NCT05782907)
- Testing
- Upadacitinib
- Where
- 89 sites in United States, Australia and 21 more
- Volunteers
- 122 people
- Sponsor
- AbbVie
Hodgkin Lymphoma
Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)
This study will examine the safety and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy in children and young adults with newly diagnosed classical Hodgkin Lymphoma (cHL) who are slow early responders (SERs)…
- Trial name
- NCT03407144
- Testing
- pembrolizumab, doxorubicin, vinblastine
- Where
- 93 sites in United States, Brazil and 14 more
- Volunteers
- 340 people
- Sponsor
- Merck Sharp & Dohme LLC
Systemic Lupus Erythematosus (SLE)
A Study in Participants With Active Systemic Lupus Erythematosus With Inadequate Response to Glucocorticoids and ≥2 Immunosuppressants
The purpose of this study is to characterize the efficacy and safety of current standard of care treatment options in participants with active systemic lupus erythematosus (SLE; including lupus nephritis) with inadequate response…
- Trial name
- BENCHMARK-SLE (NCT07175285)
- Testing
- Current standard of care treatment options
- Where
- 66 sites in United States, Argentina and 11 more
- Volunteers
- 223 people
- Sponsor
- Bristol-Myers Squibb
Thalassemia Major
Pilot Study to Assess the Safety, PK and Iron Chelating Activity of DST-0509 (Deferasirox) in Thalassemia Patients Refractory to Chelation
This study is a multicenter, open-label, two-period crossover design that evaluates the safety, tolerability, pharmacokinetics and preliminary evidence of iron chelating activity of DST-0509 as compared to Jadenu and Exjade in…
- Trial name
- NCT03637556
- Testing
- DST-0509, Jadenu, Exjade
- Where
- 4 sites in United States, Thailand
- Volunteers
- 25 people
- Sponsor
- DisperSol Technologies, LLC
Crohn's Disease
Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels.
- Trial name
- U-EMPOWER (NCT06332534)
- Testing
- Upadacitinib
- Where
- 85 sites in United States, Australia and 16 more
- Volunteers
- 111 people
- Sponsor
- AbbVie
Juvenile Idiopathic Arthritis
Efficacy, Safety, Pharmacokinetics and Immunogenicity Study of Abatacept Administered Intravenously to Treat Active Polyarticular-course Juvenile Idiopathic Arthritis in Japan
The purpose of this study is to assess the efficacy of Abatacept after intravenous administration in Japanese children and adolescents with active juvenile idiopathic arthritis who have a history of an inadequate response or…
- Trial name
- NCT01835470
- Testing
- Abatacept
- Where
- 13 sites in Japan
- Volunteers
- 23 people
- Sponsor
- Bristol-Myers Squibb
Depressive Disorder, Major
A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adolescents With Major Depressive Disorder Who Have an Inadequate Response to Selective Serotonin Reuptake Inhibitor (SSRI) and Psychotherapy
The purpose of this study is to assess the safety and tolerability of Seltorexant as adjunctive therapy to an antidepressant in adolescents with major depressive disorder (MDD) in the short-term compared with placebo.
- Trial name
- NCT04951609
- Testing
- Seltorexant
- Where
- 23 sites in United States, Italy and 2 more
- Volunteers
- 31 people
- Sponsor
- Janssen Research & Development, LLC
Generalized Anxiety Disorder
Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder
This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo as adjunctive therapy to GAD treatment in patients meeting Diagnostic…
- Trial name
- NCT06480383
- Testing
- ITI-1284 10 mg, ITI-1284 20 mg
- Where
- 56 sites in United States, Bulgaria and 3 more
- Volunteers
- 705 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Focus on Transfusion Dependent Thalassemia Patients Who Are Inadequate Responders to Deferasirox > 35mg/kgQD
Deferasirox BID (Twice a Day) in Transfusion Dependent Thalassemia Patients With Inadequate Response to High Doses
This is an open label, single arm, and multicenter study. The study will include the following phases. A screening phase which lasts for 4 weeks to determine patient eligibility.
- Trial name
- NCT01948817
- Testing
- Deferasirox
- Sponsor
- Novartis Pharmaceuticals
Colitis, Ulcerative
A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission.
- Trial name
- NCT05076175
- Testing
- Ozanimod
- Where
- 91 sites in United States, Australia and 11 more
- Volunteers
- 120 people
- Sponsor
- Bristol-Myers Squibb
Iron Deficiency Anemia
Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients With Iron Deficiency Anemia and Unsatisfactory Response Oral Iron Under Study Protocol 1VIT17044
Evaluating the Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients with Iron Deficiency Anemia and an Unsatisfactory Response to Oral Iron under Study Protocol 1VIT17044
- Trial name
- NCT04269707
- Testing
- Ferric carboxymaltose
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- American Regent, Inc.
Attention-Deficit/Hyperactivity Disorder
Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate
This study will evaluate how long it takes for ADHD symptoms to improve in subjects who are judged by the Investigator to have had an inadequate response to methylphenidate therapy.
- Trial name
- NCT01106430
- Testing
- Lisdexamfetamine Dimesylate, Atomoxetine Hydrochloride
- Where
- 64 sites in United States, Belgium and 8 more
- Volunteers
- 267 people
- Sponsor
- Shire
Primary Immune Thrombocytopenia (ITP)
A Study of Ianalumab in Addition to Eltrombopag in Pediatric Patients With Primary ITP Who Failed Corticosteroids.
The purpose of this study is to assess the efficacy, safety and pharmacokinetics (PK) of ianalumab (VAY736) in addition to eltrombopag treatment; and to inform the dose of ianalumab in pediatric patients (5 to <18 years of age)…
- Trial name
- VAYHIT-P (NCT07660172)
- Testing
- Ianalumab, Eltrombopag
- Volunteers
- 36 people
- Sponsor
- Novartis Pharmaceuticals
Dermatitis Atopic
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor
This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe AD on background TCS who have had inadequate…
- Trial name
- AQUA (NCT06241118)
- Testing
- Amlitelimab, Topical corticosteroids, Topical tacrolimus or pimecrolimus
- Where
- 154 sites in United States, Argentina and 20 more
- Volunteers
- 464 people
- Sponsor
- Sanofi
High-Risk Neuroblastoma, Patient With Insufficient Response Chemoimmunotherapy
High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)
This is an international multicenter, open-label, randomized phase III trial including three sequential randomizations to assess efficacy of induction and consolidation chemotherapies and radiotherapy for patients with high-risk…
- Trial name
- HR-NBL2 (NCT04221035)
- Testing
- Vincristine, Carboplatin, Etoposide
- Where
- 142 sites in Australia, Austria and 18 more
- Volunteers
- 800 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris