NIHR 70 day Performance in Delivery Report Q3 2019-20

REC IRAS # Study Title Target # of participants

available

Min Patients

Max Patients

Target date to recruit

participants available

Date Agreed to Recruit

Target Patients

Total Number of Patients

Recruited at Agreed Date

Date study closed to

recruitment

Total Study Participants

Recruited

Reason for recruitment

end

1 18/LO/1237 247688

A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adults with

Treatment-Resistant Migraine - The CONQUER Study

Range Agreed 3 14 Date Agreed 31/03/2019 1 18/01/2019 1 Recruitment

Finished

2 18/NE/0029 240385

A Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of

the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients

with Previously Treated Hepatocellular Unresectable

Carcinoma.

Range Agreed 2 4 Date Agreed 30/09/2019 8 25/01/2019 8 Recruitment

Finished

3 18/EM/0007 236547

LIBERTY EXTENSION: An International Phase 3 Open-Label,

Single-Arm, Long-Term Efficacy and Safety Extension Study to Evaluate

Relugolix Co-Administered with Low-Dose Estradiol and

Norethindrone Acetate in Women with Heavy Menstrual Bleeding

Associated with Uterine Fibroids

Number Agreed 1 1 Date Agreed 31/01/2019 0 28/01/2019 0 Withdrawn

By Sponsor

4 16/LO/0805 200094

A Phase II Study of Pembrolizumab (MK-3475) as Monotherapy in

Subjects with Previously Systemically Treated Advanced

Hepatocellular Carcinoma

Range Agreed 2 4 Date Agreed 06/03/2016 0 31/01/2019 6 Recruitment

Finished

5 18/LO/0410 239305 A Phase 2, randomised, single-masked, active-controlled,

multicentre study to evaluate the efficacy and safety of intravitreal

THR-317 when administered alone

Range Agreed

1 2 Date Agreed 31/01/2019 3 31/01/2019 3 Recruitment Finished

Page 1 of 9

or in combination with ranibizumab, in diabetic macular oedema (DME) patients with a

poor or no response to anti-vascular endothelial growth factor

(anti-VEGF) treatment

6 14/NE/1099 144103

Phase III, Randomized, Multi-centre Double-Blind, Double-

Dummy Study To Evaluate The Efficacy And Safety Of Etrolizumab

Compared With Infliximab Inpatients With Moderate To

Severe Active Ulcerative Colitis Who Are Naive To TNF inhibitors

Range Agreed 3 5 Date Agreed 31/03/2019 5 26/02/2019 5 Recruitment

Finished

7 17/LO/1103 230709

18184-Two-part, double-blind, placebo-controlled, randomized, parallel-group study: (Part 1) in

healthy male volunteers to assess safety and tolerability of ascending

repeated oral doses of BAY 1817080, followed by (Part 2) two-

way crossover administration of four different doses in patients

with refractory chronic cough to assess safety, tolerability and efficacy for proof of concept

Range Agreed 3 7 Date Agreed 31/01/2019 1 06/03/2019 7 Recruitment

Finished

8 18/NI/0128 247591

A PHASE 2 DOSE RANGING, RANDOMIZED, DOUBLE BLIND,

AND PLACEBO-CONTROLLED STUDY EVALUATING THE SAFETY,

TOLERABILITY, PHARMACOKINETICS AND

EFFICACY OF EDP-305 IN SUBJECTS WITH NONALCOHOLIC

STEATOHEPATITIS (NASH)

Range Agreed 4 6 Date Agreed 31/12/2018 2 15/03/2019 2 Recruitment

Finished

9 18/LO/0326 240410 DISRUPT CAD II POST-MARKET Number 15 15 Date Agreed 31/05/2019 9 25/03/2019 9 Withdrawn

Page 2 of 9

STUDY Agreed By Sponsor

10 15/EM/0443 187983A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing

Multiple Sclerosis

Number Agreed 1 1 Date Agreed 30/06/2020 1 31/03/2019 1 Withdrawn

By Host

11 16/SC/0391 208610

A randomized, double-blind, double-dummy, parallel-group

study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with

relapsing forms of multiple sclerosis

Range Agreed 1 4 Date Agreed 31/12/2017 3 31/03/2019 3 Withdrawn

By Host

12 17/NE/0165 217768

An Open Label, Single-Arm Study To Evaluate The Effectiveness And Safety Of Ocrelizumab In Patients

With Early Stage Relapsing Remitting Multiple Sclerosis

Number Agreed 4 4 Date Agreed 31/05/2018 5 31/03/2019 5 Withdrawn

By Host

13 17/EM/0155 206803

Multicenter, randomized, double-blind, parallel-group, add-on,

superiority study to compare the efficacy and safety of ponesimod to placebo in subjects with active relapsing multiple sclerosis who

are treated with dimethyl fumarate (Tecfidera®)

Number Agreed 3 3 Date Agreed 31/12/2018 1 31/03/2019 1 Withdrawn

By Host

14 17/EM/0361 234065

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group

Study to Assess the Efficacy and Safety of BIIB033 When Used

Concurrently with Background Disease-Modifying Therapies in

Subjects with Relapsing Forms of Multiple Sclerosis

Range Agreed 2 7 Date Agreed 31/12/2019 2 31/03/2019 2 Withdrawn

By Host

15 18/NE/0214 245998 A single arm, open label multicentre extension study to evaluate the effectiveness and

safety of Ocrelizumab in patients

Range Agreed

1 6 Date Agreed 31/01/2019 0 31/03/2019 0 Withdrawn By Host

Page 3 of 9

with multiple sclerosis previously enrolled in a F. Hoffmann-La Roche

sponsored Ocrelizumab Phase IIIb/IV clinical trial

16 16/LO/1244 200385

A Phase 3 Randomized, Open-Label Study Comparing Pexa-Vec

(Vaccinia GM-CSF / Thymidine Kinase-Deactivated Virus) Followed

by Sorafenib Versus Sorafenib in Patients with Advanced

Hepatocellular Carcinoma (HCC) Without Prior Systemic Therapy

Number Agreed 3 3 Date Agreed 31/03/2019 0 01/04/2019 0 Recruitment

Finished

17 19/SC/0028 257304

A Multi-center, Open-label, Long-term Extension Study of ABI-H0731 + Nucleos(t)ide as Finite Treatment

for Chronic Hepatitis B Patients

Range Agreed 2 4 Date Agreed 30/06/2019 2 03/04/2019 2 Recruitment

Finished

18 17/EM/0412 234907

An adaptive seamless randomized, double-blind, placebo-controlled, dose ranging study to investigate the efficacy and safety of LNP023

in primary IgA nephropathy patients

Number Agreed 2 2 Date Agreed 30/09/2018 0 12/04/2019 4 Recruitment

Finished

19 18/WM/0204 244427

A Phase 3, Open-label Study Evaluating the Long-term Safety

and Efficacy of VX-445 Combination Therapy in Subjects

With Cystic Fibrosis Who Are Homozygous or Heterozygous for

the F508del Mutation Vertex

Range Agreed 1 6 Date Agreed 30/09/2019 4 15/04/2019 4 Recruitment

Finished

20 15/LO/1192 183464

A Randomized, Open-label, Phase 2 Trial of Ponatinib in Patients with

Resistant Chronic Phase Chronic Myeloid Leukemia to Characterize the Efficacy and Safety of a Range

of Doses

Number Agreed 10 10 Date Agreed 30/04/2019 3 26/04/2019 3 Recruitment

Finished

21 17/NE/0210 226995 VALENS: A Phase 1/2, Randomized, Range 1 3 Date Agreed 30/04/2019 1 30/04/2019 1 Recruitment

Page 4 of 9

Open-Label, Ascending-Dose, Delayed-Treatment Concurrent

Control Clinical Study to Evaluate the Safety and Preliminary Efficacy of AT342, an AAV8-Delivered Gene Transfer Therapy in Crigler-Najjar Syndrome Subjects Aged 1 Year

and Older

Agreed Finished

22 17/LO/1930 235819

A Randomized, Controlled, Open-Label, Multiple Ascending Dose

Study of Intravenous Brincidofovir in Adult Allogeneic Hematopoietic

Cell Transplant Recipients with Adenovirus Viremia

Range Agreed 1 2 Date Agreed 28/02/2019 0 10/05/2019 0 Withdrawn

By Sponsor

23 17/EM/0259 226888

ANEMEX UK Trial: Artificial Intelligence for Optimal Anaemia Management in End-stage Renal

Disease: The Anaemia Control Model (ACM) Trial

Number Agreed 240 240 Date Agreed 31/12/2019 88 22/05/2019 88 Withdrawn

By Sponsor

24 17/NW/0674 234380

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing

the Efficacy, Safety and Tolerability of monthly Subcutaneous

Administration of fremanezumab Versus Placebo for the Preventive Treatment of Migraine in patients

with inadequate response to 2 to 4 other preventive treatments

Range Agreed 3 15 Date Agreed 31/08/2019 18 06/06/2019 18 Recruitment

Finished

25 15/NI/0145 158005 A Phase IB/II Study Evaluating the Safety, Tolerability and Anti-

Tumour Activity of Polatuzumab Vedotin (DCDS4501A) in

Combination with Rituximab (R) or OBINUTUZUMAB Obinutuzumab

(G) plus Bendamustine (B) in

Number Agreed

2 2 Date Agreed 30/09/2019 2 13/06/2019 2 Recruitment Finished

Page 5 of 9

Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma

26 18/LO/0355 240367Effects of oral levosimendan

(ODM-109) on respiratory function in patients with ALS

Range Agreed 3 10 Date Agreed 31/05/2019 3 24/06/2019 3 Recruitment

Finished

27 16/LO/2026 215506

A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Safety and Efficacy

of Sofosbuvir/Velpatasvir in Adolescents and Children with

Chronic HCV Infection

Range Agreed 2 6 Date Agreed 27/06/2019 11 27/06/2019 11 Recruitment

Finished

28 16/NW/0620 206738

PHASE 3, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED

STUDY EVALUATING THE EFFICACY AND SAFETY OF ORAL AKB-6548

FOR THE CORRECTION OF ANEMIA IN SUBJECTS WITH NON-DIALYSIS-

DEPENDENT CHRONIC KIDNEY DISEASE (NDD-CKD)

Number Agreed 4 4 Date Agreed 30/06/2019 9 05/07/2019 9 Recruitment

Finished

29 16/NW/0621 206740

PHASE 3, RANDOMIZED, OPENLABEL, ACTIVE-CONTROLLED STUDY EVALUATING THE EFFICACY

AND SAFETY OF ORAL AKB-6548 COMPARED TO DARBEPOETIN IN THE MAINTENANCE TREATMENT

OF ANEMIA IN SUBJECTS CONVERTED FROM CURRENT ESA

TREATMENT FOR ANEMIA SECONDARY TO NON-DIALYSIS-DEPENDENT CHRONIC KIDNEY

DISEASE (NDD-CKD)

Range Agreed 4 6 Date Agreed 30/06/2019 7 05/07/2019 7 Recruitment

Finished

30 18/NW/0098 242717 Two-part, double-blind, placebo-controlled, randomized, parallel-group study: (Part 1) in healthy

male subjects to assess safety and tolerability of ascending repeated

Number Agreed

2 2 Date Agreed 10/05/2019 3 08/07/2019 3 Recruitment Finished

Page 6 of 9

oral doses of BAY 1902607 including its effect on the

pharmacokinetics of a sub-therapeutic dose of midazolam

(MDZ), followed by (Part 2) a two-way crossover administration of

four different doses of BAY 1902607 in patients with refractory

chronic cough to assess safety, tolerability and efficacy for proof

of concept

31 15/EE/0442 181302

A PHASE 3, MULTICENTER, OPEN-LABEL, RANDOMIZED STUDY

COMPARING THE EFFICACY AND SAFETY OF AG-221 (CC-90007) VERSUS CONVENTIONAL CARE REGIMENS IN OLDER SUBJECTS

WITH LATE STAGE ACUTE MYELOID LEUKEMIA HARBORING AN

ISOCITRATE DEHYDROGENASE 2 MUTATION

Range Agreed 1 3 Date Agreed 31/07/2019 1 12/07/2019 1 Recruitment

Finished

32 17/WM/0041 220645

A 52-week open-label (sponsor-blind), randomized, active

controlled, parallel-group, multi-center study to evaluate the

efficacy and safety of daprodustat compared to recombinant human

erythropoietin in subjects with anemia associated with chronic

kidney disease who are initiating dialysis

Number Agreed 2 2 Date Agreed 31/07/2019 7 17/07/2019 7 Recruitment

Finished

33 18/LO/0235 240315

An Open Label Extension Study of GBT440 Administered Orally to Patients with Sickle Cell Disease

Who Have Participated in GBT440 Clinical Trials

Range Agreed 2 6 Date Agreed 31/12/2019 1 31/07/2019 1 Recruitment

Finished

Page 7 of 9

34 18/LO/1007 242697

Patient-Reported Outcomes with the Accu-Chek® Solo Micropump System vs. Multiple Daily Injection Therapy vs. mylife OmniPod® in

Patients with Type 1 Diabetes

Number Agreed 4 4 Date Agreed 31/07/2019 4 31/07/2019 4 Recruitment

Finished

35 18/SC/0094 240710

A Bioanalytical Method Cross-validation study to compare the Finger Prick Whole Blood MITRA

Assay Method with the Established Venepuncture Whole Blood

Method for Quantitative Determination of Tacrolimus Blood

Concentrations in Transplant Patients

Range Agreed 20 25 Date Agreed 31/10/2018 21 01/08/2019 21 Recruitment

Finished

36 18/LO/1311 248599

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLEMASKED,

ACTIVE COMPARATOR-CONTROLLED STUDY TO EVALUATE

THE EFFICACY AND SAFETY OF RO6867461 IN PATIENTS WITH

DIABETIC MACULAR EDEMA (RHINE)

Number Agreed 4 4 Date Agreed 31/08/2019 4 22/08/2019 4 Recruitment

Finished

37 16/NE/0363 215166

A randomized, double-blind, placebo-controlled, multicenter,

dose-range, proof-of-concept, 24-week treatment study of IVA337 in

adult subjects with nonalcoholic steatohepatitis (NASH).

Range Agreed 2 4 Date Agreed 31/12/2018 1 30/08/2019 3 Recruitment

Finished

38 17/SS/0110 226448

An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics,

Safety, and Efficacy of Glecaprevir/Pibrentasvir in

Pediatric Subjects with Genotypes 1 – 6 Chronic Hepatitis C Virus

(HCV) Infection

Number Agreed 2 2 Date Agreed 31/08/2019 3 31/08/2019 3 Recruitment

Finished

39 18/LO/0855 237285 A Randomized, Open-label, Range 2 5 Date Agreed 30/11/2019 3 20/09/2019 3 Recruitment

Page 8 of 9

Multicenter Phase 3 Study to Compare the Efficacy and Safety of

BGB-A317 versus Sorafenib as First-Line Treatment in Patients

with Unresectable Hepatocellular Carcinoma

Agreed Finished

40 18/WS/0201 251717

A 52-week, placebo-controlled, randomized, Phase 3 study to

evaluate the safety and efficacy of seladelpar in subjects with primary

biliary cholangitis (PBC) and an inadequate response to or an

intolerance to ursodeoxycholic acid (UDCA)

Range Agreed 2 3 Date Agreed 30/11/2019 4 11/10/2019 4 Recruitment

Finished

41 18/WA/0211 240366

A Phase 2 Dose Ranging, Randomized, Double Blind, and

Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or

without an Inadequate Response to Ursodeoxycholic Acid (UDCA)

Number Agreed 2 2 Date Agreed 31/12/2018 1 14/10/2019 3 Recruitment

Finished

42 18/NE/0146 244849

A Phase 1 Study to Evaluate the Safety, Tolerability, and

Pharmacokinetics ofPTI-808 in Healthy Adult Subjects and in

Adults with Cystic Fibrosis

Range Agreed 1 3 Date Agreed 31/10/2019 2 11/11/2019 2 Recruitment

Finished

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