Plain language summaries of study results
Plain language summaries of clinical study results are intended to share the findings of clinical research with study participants, patients and the public in easy-to-understand language. UCB currently provides these summaries for:
- Pivotal studies or studies that were key for the approval of medicines
- Pivotal studies for medicines where clinical development has been terminated globally.
- Plans are underway to expand lay summary development to include additional studies and to provide these summaries in additional languages in the future.
Plain language summaries are also included with other study information via the Compounds drop-down menu on the Clinical Studies Index page.
Bimekizumab
- AS0010 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis
- AS0011 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis
- HS0003 - A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
- HS0004 - A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa
- PA0010 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Reference (Adalimumab) Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
- PA0011 - A Multicenter, Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis.
- PS0008 - Phase 3, Multicenter, Randomized, Double-Blind Study With an Active-Controlled Initial Treatment Period Followed by a Dose-Blind Maintenance Treatment Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
- PS0009 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
- PS0013 - A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study With an Initial Treatment Period Followed by a Randomized Withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects with Moderate to Severe Chronic Plaque
- PS0014 - A Multicenter, Open-Label Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
- PS0015 - A Multicenter, Randomized, Double-Blind, Secukinumab-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
- PS0032 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Korean Study Participants With Moderate to Severe Plaque Psoriasis
- UP0119 - An Open-Label, Randomized, Parallel-Group, Single-Dose Bioequivalence Study of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection Using an Autoinjector in Healthy Study Participants
Brivaracetam
- EP0231 - A Multiple-Dose, Open-Label, Randomized, 2-Way Cross-Over Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Participants
- N01252 - Brivaracetam for the treatment of partial‑onset seizures (focal seizures) in people from 16 to 70 years old with epilepsy
- N01253 - Brivaracetam for the treatment of partial-onset seizures (focal seizures) in people from 16 to 70 years old with epilepsy
- N01358 - Brivaracetam for the treatment of partial-onset seizures (focal seizures) in people from 16 to 80 years old with epilepsy
Certolizumab pegol
- AKS001 - Certolizumab Pegol for the Treatment of Axial Spondyloarthritis in Adults
- C87014 - Certolizumab Pegol for the Treatment of Rheumatoid Arthritis in Adults
- C87027 - Certolizumab Pegol for the Treatment of Rheumatoid Arthritis in Adults
- C87031 - Certolizumab Pegol for the Treatment of Crohn’s Disease in Adults
- C87032 - Certolizumab Pegol for the Treatment of Crohn’s Disease in Adults
- C87050 - Certolizumab Pegol for the Treatment of Rheumatoid Arthritis in Adults
- C87077 - A study to learn if certolizumab pegol plus methotrexate works in participants who are already taking methotrexate
- PS0002 - A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Study Followed by a Dose-Blind Period and Open-Label Follow-Up to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects With Moderate to Severe Chronic Plaque Psoriasis
- PS0003 - A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled Study Followed by a Placebo-Controlled Maintenance Period and Open-Label Follow-Up to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects With Moderate to Severe Chronic Plaque Psoriasis
- PS0005 - A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Study Followed by a Dose-Blind Period and Open-Label Follow-Up to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects With Moderate to Severe Chronic Plaque Psoriasis
- PSA001 - Certolizumab Pegol for the Treatment of Psoriatic Arthritis in Adults
- RA0043 - A Multicenter, Open-label Study to Assess the Pharmacokinetics, Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Polyarticular-course Juvenile Idiopathic Arthritis (JIA)
- RA0044 - A study to learn if certolizumab pegol works in Chinese participants with active rheumatoid arthritis
- RA0055 - A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of DMARD-naïve adults with early active rheumatoid arthritis
- RA0077 - Direct Comparison of Certolizumab Pegol versus Adalimumab in Rheumatoid Arthritis: 2-Year Efficacy and Safety Results from the Randomized EXXELERATE Study
- UP0016 - To look at the amount of certolizumab pegol in breast milk (CRADLE)
- UP0017 - To look at the transfer of certolizumab pegol across the placenta (CRIB)
- UP0085 - A Postmarketing, Multicenter, Longitudinal, Prospective, Pharmacokinetic, Phase 1b Study In Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia® (Certolizumab Pegol)
Fenfluramine
- ZX008-1501, ZX008-1502, ZX008-1504 - This is a summary of the main results of the 3 studies: ZX008-1501, ZX008-1502, ZX008-1504 - A study to learn how well fenfluramine works and how safe it is in children and young adults with Dravet syndrome
- ZX008-1601 (EP0214) - A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults with LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults with LGS
Lacosamide
- EP0008 - A study to learn if lacosamide helps control seizures in Chinese and Japanese participants with epilepsy who are taking their usual anti-seizure medicines
- EP0024 - A Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Intravenous Lacosamide as Replacement for Oral Lacosamide in Japanese Adults With Partial-onset Seizures With or Without Secondary Generalization
- SP667 - Lacosamide in Adults for the Treatment of Epileptic Partial Seizures
- SP754 - Lacosamide for the Treatment of Epileptic Partial Seizures in Adolescents (16 years and older) and Adults
- SP755 - Lacosamide for the Treatment of Epileptic Partial Seizures in Adolescents (16 years and older) and Adults
- SP902 - A historical-controlled, multicentre, double blind, randomized trial to assess the efficacy and safety of conversion to lacosamide 400mg/day monotherapy in subjects with partial onset seizures
- SP0969 - A multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy and safety of lacosamide as adjunctive therapy in subjects with epilepsy ≥4 years to <17 years of age with partial-onset seizures
- SP0982 - A double-blind, randomized, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of lacosamide as adjunctive therapy for uncontrolled primary generalized tonic-clonic seizures in subjects with idiopathic generalized epilepsy
- SP0993 - A multicenter, double-blind, double-dummy, randomized, positive controlled study comparing the efficacy and safety of lacosamide (200 to 600mg/day) to controlled release carbamazepine (400 to 1200mg/day), used as monotherapy in subjects (≥16 years) newly or recently diagnosed with epilepsy and experiencing partial onset or generalized tonic clonic seizures
Levetiracetam
- N051 - Evaluation of the efficacy and tolerability of UCB L059 (500 and 1000 mg b.i.d., tablets) add-on treatment in refractory epileptic patients with partial onset seizures: a 32-week double-blind placebo-controlled crossover multicenter trial
- N132 - A study to learn if levetiracetam works in participants with epilepsy who are taking their usual anti-seizure medicines
- N138 - Evaluation of the efficacy and tolerability of ucb L059 (1500 mg b.i.d., 500 mg tablets) monotherapy in epileptic patients with complex partial onset seizures, having experienced improved seizure control under add-on treatment
- N159 - Evaluation of The Efficacy and Tolerability of Levetiracetam Add-On Treatment in Refractory Pediatric Patients With Partial Onset Seizures: A 28-Week Double-Blind, Placebo-Controlled Multi-center Trial
- N01009 - A Double-Blind, Randomized, Multicenter, Placebo-Controlled, In-Patient, Maximum 34 Day Study of Levetiracetam Oral Solution (20-50 mg/kg/day) as Adjunctive Treatment of Refractory Partial Onset Seizures in Pediatric Epileptic Subjects Ranging in Age from 1 Month to Less Than 4 Years of Age
- N01057 - Levetiracetam for the Treatment of Generalised Epilepsy in Children and Adults
- N01061 - A study to learn if levetiracetam works when taken by itself in people with newly diagnosed epilepsy who have focal seizures or grand mal seizures
- N01102 - A Double-blind, Placebo-controlled, Randomized Study: 16-week Evaluation of the Efficacy and Safety of Levetiracetam (LEV) as Add-on Therapy in Adults and Adolescents Older than 16 Years Suffering from Partial Seizures
- N01148 - A study to see if levetiracetam worked and to learn about its safety in children and teenagers 1 month and older with epilepsy
- N01159 - A double-blind, multicenter, randomized, placebo-controlled study to evaluate the efficacy and safety of adjunctive treatment with oral levetiracetam (L059) in epilepsy patients aged ≥16 with generalized tonic-clonic (GTC) seizures
- N01221 - A study to learn if levetiracetam works in Japanese participants with epilepsy who are taking their usual anti-seizure medicines
- N01274 - Levetiracetam for the Treatment of Epilepsy in Children (4 - 16 Years Old)
- N01275 - Levetiracetam for Treatment of Epilepsy in Children (1 Month Old to 4 Years Old)
- N01364 - A study to learn if levetiracetam works when taken by itself in Chinese participants with newly diagnosed epilepsy who have focal seizures
- N01375 - A study to learn how levetiracetam worked when taken by itself in Japanese participants with newly diagnosed epilepsy
- N01378 - An open-label, multicenter study to evaluate the safety of adjunctive treatment with intravenous levetiracetam (L059IV) in epilepsy patients aged ≥16 years with partial onset seizures
Romosozumab
- 20070337 - A Multicenter, International, Randomized, Double-blind, Placebocontrolled, Parallel-group Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
- 20110142 - A Multicenter, International, Randomized, Double-blind, Alendronatecontrolled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
- 20110174 - A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Men With Osteoporosis
Rotigotine
- SP506 - Rotigotine in Adults for the Treatment of Early Parkinson’s Disease
- SP512 - Rotigotine in Adults for the Treatment of Early Parkinson’s Disease
- SP513 - Rotigotine in Adults for the Treatment of Early Parkinson’s Disease
- SP515 - Rotigotine for the Treatment of Advanced Parkinson’s Disease in Adults
- SP650 - Rotigotine in Adults for the Treatment of Advanced Parkinson’s Disease
- SP790 - Rotigotine for the Treatment of Restless Legs Syndrome in Adults
- SP792 - Rotigotine for the Treatment of Restless Legs Syndrome in Adults
- SP0914 - A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of the Efficacy and Safety of the Rotigotine Transdermal Patch in Chinese Subjects with Early-Stage Idiopathic Parkinson’s Disease
- SP1037 - A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of Rotigotine Transdermal Patch in Chinese Subjects with Advanced-stage, Idiopathic Parkinson’s Disease Who Are Not Well Controlled on Levodopa
Rozanolixizumab
- AIE001 - A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis
- MG0003 - A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
- MG0007 - An Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis
- MG0020 - An Open-label, Crossover Study to Evaluate Rozanolixizumab Self-administration by Study Participants With Generalized Myasthenia Gravis
- TP0003 - Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
- TP0004 - An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia
- UP0106 - A Randomized, Participant-Blind, Investigator-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Rozanolixizumab Administered Subcutaneously Via Manual Push Versus Syringe Driver to Healthy Participants