AmyloidosisPhase 1NCT01777243

A Study to Evaluate the Safety of GSK2398852 When Co-administered With GSK2315698 in Patients With Systemic Amyloidosis

A Phase 1 study testing GSK2398852 and GSK2315698 in people with Amyloidosis, run by GlaxoSmithKline at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Amyloidosis
What is being tested?: GSK2398852 and GSK2315698
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 2 sitesUnited Kingdom
Study dates: 13 May 2013to 22 Dec 2015
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject has been medically diagnosed with systemic amyloidosis and falls into one of the patient groups (small to moderate amyloid load involving the spleen for Part A; moderate to large amyloid load involving the spleen (to a moderate/large extent) for Part A (following agreement from external safety committee); moderate to large amyloid load involving the spleen and liver (spleen involved to a moderate/large extent) for Part A extension (if required); and moderate to large amyloid load involving the spleen (and liver in subset of subjects only) for Part B).
Alanine aminotransferase (ALT) <3x upper limit of normal (ULN) and bilirubin <1.5x ULN (isolated bilirubin >1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Male or female between 18 and 70 years of age inclusive, at the time of signing the informed consent.
Subject is ambulant and capable of attending for the study visit schedule.
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
A female subject is eligible to participate if she is of non-childbearing potential; or females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the approved contraception methods.
Male subjects with female partners of child-bearing potential must agree to use one of the approved contraception methods.
Smokers (<10 /day) are permitted but must be willing to abstain for the duration of residential study sessions

Who cannot join

A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
The subject has participated in a clinical trial and has received an investigational therapeutic product (unlicensed) within the following time period prior to the first dosing day in the current study: 3 months, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). This timeframe will not apply to short term administration of GSK2315698 in study CPH114527.
Pregnant females as determined by positive serum or urine human chorionic gonadotropin (hCG) test at screening or prior to dosing.
Lactating females.
Estimated glomerular filtration rate (GFR)<30 milliliter (mL)/minute (min) [<60 mL/min for the first 4 subjects to be enrolled]
Evidence of an active urinary sediment on microscopy as evidenced by the presence of red cell casts

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Decompensated cardiac failure or a recent history of syncope associated with cardiac disease.
In a subject in whom there is a clinical suspicion of cardiac amyloid, an echocardiogram is consistent with significant cardiac amyloid, whether symptomatic or not.
Clinically significant anaemia- hemoglobin (Hb) <9 gram (g)/deciliter (dL).
Use of prohibited medications.
Poor or unsuitable venous access.
Subjects with a QT interval corrected using Fridericia's formulas (QTcF) of >480 ms or other electrocardiogram (ECG) abnormalities which, in the opinion of the investigator are clinically significant and may increase safety risk.
Uncontrolled hypertension with systolic blood pressure (BP) >170 mmHg and /or diastolic >100 mmHg
Presence of any co-morbid condition (e.g. severe or unstable coronary artery disease; moderate-severe chronic obstructive pulmonary disease) which in the opinion of the investigator would increase the potential risk to the subject.
Subjects with active vasculitis
Exclusions from Equilibrium contrast Magnetic Resonance Imaging (EqMRI) scanning [Contraindications to Magnetic Resonance Imaging (MRI) scanning including, but not limited to: Intracranial aneurism clips (except Sugita); History of intra-orbital metal fragments that have not been removed by an MD (as confirmed by orbital X-Ray); Pacemakers and non-MR compatible heart valves; Inner ear implants; History of claustrophobia; estimated GFR <30 mL/min (gadolinium exclusion)]
Subjects with dementia or a diagnosis of cerebral amyloid angiopathy.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

GSK Investigational Site
Cambridge, CB2 2GG
GSK Investigational Site
London, SE1 1YR

Other trials in United Kingdom

About this study

Official title: A Single Dose First in Human Study of GSK2398852 Co-Administered With GSK2315698 in Patients With Systemic Amyloidosis

The study will be conducted in two parts. The first (Part A) will be an open label single dose escalation part beginning with the proposed starting dose level of GSK2398852 as 5 milligram (mg) [approximately equivalent to 0.1 mg/kilogram (kg)]. The next escalation dose levels are proposed as 1 mg/kg, 3 mg/kg, 10 mg/kg and 30 mg/kg. GSK2315698 will be administered at variable doses until the concentration of the serum amyloid P component monoclonal antibody (SAP mAb) has fallen below 100 nanogram/millilitre (ng/mL). Decisions about these next dose levels will be made following safety review of the prior subjects' data; dose levels may be changed (increased and lowered) and dose levels may be repeated depending on the observed safety such that Part A extension study may be performed. In addition, pharmacokinetics of GSK2315698 (SAP depleter) and GSK2398852 (anti-SAP mAb), and circulating SAP concentrations will be assessed. Dose escalation in Part A will continue to the highest well tolerated dose or the highest allowable dose. Subjects will be closely monitored and will undergo Equilibrium contrast Magnetic Resonance Imaging (EqMRI) including organ volume, Elastography and Liver Biopsy if required.

Part B will be a randomized partially blinded part with the principal objective of assessing the dose response of the GSK2398852 in more detail. Subjects will be assigned to one of approximately 5 dose groups from Part A. The precise selection of numbers of subjects and dose levels will be informed by the results from Part A.

Conditions: Amyloidosis
Being tested: GSK2398852, GSK2315698
Keywords: pharmacokinetic, systemic amyloidosis, safety, dose escalation, Carboxy Pyrrolidine Hexanoyl Pyrrolidine Carboxylate (CPHPC), biomarker, GSK2315698, GSK2398852, SAP, pharmacodynamic, co-administration, intravenous
Medical subject headings: Amyloidosis, Immunoglobulin Light-chain Amyloidosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK2398852Drug
Unit dose strength: 100 mg/mL provided as 1 mL solution per vial. GSK2398852 dosage levels variable with the proposed starting dose level of GSK2398852 as 5 mg [approximately equivalent to 0.1 mg/ kg]. The next escalation dose levels are proposed as 1 mg/kg, 3 mg/kg, 10 mg/kg and 30 mg/kg.
GSK2315698Drug
Unit dose strength: 200 mg/mL stock to be diluted. GSK2315698 will be administered at variable dosed until the concentration of the serum amyloid P component monoclonal antibody (SAP mAb) has fallen below 100 ng/mL.

Study groups in NCT01777243
Study group	Role	What they receive
Part A Arm	Experimental	Two subjects in Part A will receive starting dose level of GSK2398852 as 5 milligram (mg) [approximately equivalent to 0.1 mg/kilogram (kg)]. The next escalation dose levels in two subjects each are proposed as 1 mg/kg, 3 mg/kg, 10 mg/kg and 30 mg/kg. GSK2315698 will be administered at variable dosed until the concentration of the SAP mAb has fallen below 100 ng/mL. Receives: Drug: GSK2398852; Drug: GSK2315698
Part B Arm	Experimental	The precise selection of numbers of subjects and dose levels in Part B will be informed by the results from Part A. Receives: Drug: GSK2398852; Drug: GSK2315698

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety of GSK2398852 as assessed by number of subjects with AEs in Part A and in Part B
Adverse events (AEs) will be collected from the start of Study Treatment and until the follow-up contact.
Measured: Continuous throughout the study
Safety of GSK2398852 as assessed by clinical laboratory tests in Part A and in Part B
Safety data will include assessments of clinical laboratory tests (hematology, clinical chemistry and urinalysis).
Measured: At scheduled intervals upto Day 42 in each Part.
Safety of GSK2398852 as assessed by vital signs measurements in Part A and in Part B
Safety data will include measurements of vital signs (semi supine systolic and diastolic blood pressure, pulse rate and temperature measured orally).
Measured: At scheduled intervals upto Day 42 in each Part.
Safety of GSK2398852 as assessed by ECG readings in Part A and in Part B
Safety data will include single 12-lead electrocardiogram (ECG) readings obtained at each timepoint during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals.
Measured: At scheduled intervals upto Day 42 in each Part.
PK profile of GSK2315698 and GSK2398852 in Part A and in Part B
Pharmacokinetic (PK) profile GSK2315698 and GSK2398852 was performed to evaluate PK of single doses of GSK2398852 and GSK2315698 when co-administered.
Measured: In Part A and Part B on Day -2, Day 1 (pre-dose, 1 hour [hr], 2 hr, 3 hr, 4 hr, 8 hr, 12 hr), Day 2, Day 3, Day 4, Day 6, Day 14, Day 21, Day 42
Dose response of single doses of GSK2398852 when co-administered with GSK2315698 in Part B
The main measure of dose response will be determined by information from part A (and Part A extension if required). The options are: -Volume of distribution of gadolinium in the spleen as a measure of amyloid load (EqMRI); and -Liver histology examination for presence of giant cells, activation of macrophages, and amyloid clearance.
Measured: Baseline, Day 6, Day 14 and Day 42 in Part B.

Secondary outcomes (2)

SAP concentrations measurement
SAP concentrations before administration of GSK2398852 will be measured using Hycult ELISA assay; and SAP concentrations after administration of GSK2398852 will be measured by GSK assay in both Parts.
Measured: Baseline, Day -3, Day -2, Day -1, Day 42 in each Part.
Measurement of anti-drug antibodies before and after treatment with GSK2398852
Anti-drug antibodies before and after treatment with GSK2398852 will be measured to assess the immunogenicity of GSK2398852 when co-administered with GSK2315698.
Measured: Day 1 pre-dose, Day 21, Day 42 in each Part.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 May 201322 Dec 2015

First posted28 Jan 2013 (estimated)
Study start13 May 2013
Primary completion22 Dec 2015
Study completion22 Dec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for AmyloidosisStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01777243
Sponsor's protocol ID: 115570
Status last verified: Jul 2018
First submitted: 24 Jan 2013
Last updated: 24 Jul 2018
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

Richards D, Millns H, Cookson L, Lukas MA. An observational, non-interventional study for the follow-up of patients with amyloidosis who received miridesap followed by dezamizumab in a phase 1 study. Orphanet J Rare Dis. 2022 Jul 9;17(1):259. doi: 10.1186/s13023-022-02405-7.
PubMed 35810311
Richards DB, Cookson LM, Barton SV, Liefaard L, Lane T, Hutt DF, Ritter JM, Fontana M, Moon JC, Gillmore JD, Wechalekar A, Hawkins PN, Pepys MB. Repeat doses of antibody to serum amyloid P component clear amyloid deposits in patients with systemic amyloidosis. Sci Transl Med. 2018 Jan 3;10(422):eaan3128. doi: 10.1126/scitranslmed.aan3128.
PubMed 29298867
Richards DB, Cookson LM, Berges AC, Barton SV, Lane T, Ritter JM, Fontana M, Moon JC, Pinzani M, Gillmore JD, Hawkins PN, Pepys MB. Therapeutic Clearance of Amyloid by Antibodies to Serum Amyloid P Component. N Engl J Med. 2015 Sep 17;373(12):1106-14. doi: 10.1056/NEJMoa1504942. Epub 2015 Jul 15.
PubMed 26176329

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Dose First in Human Study of GSK2398852 Co-Administered With GSK2315698 in Patients With Systemic Amyloidosis
ClinicalTrials.gov ID: NCT01777243
Acronym / sponsor ID: 115570
Conditions: Amyloidosis
Keywords: pharmacokinetic, systemic amyloidosis, safety, dose escalation, Carboxy Pyrrolidine Hexanoyl Pyrrolidine Carboxylate (CPHPC), biomarker, GSK2315698, GSK2398852
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Collaborators: Imperial College London, Heart Hospital, Royal Free Hospital NHS Foundation Trust, Quintiles, Inc.
Study start: 13 May 2013 (actual)
Primary completion: 22 Dec 2015 (actual)
Study completion: 22 Dec 2015 (actual)
First posted: 28 Jan 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Part A Arm	Experimental	Drug: GSK2398852, Drug: GSK2315698Two subjects in Part A will receive starting dose level of GSK2398852 as 5 milligram (mg) [approximately equivalent to 0.1 mg/kilogram (kg)]. The next escalation dose levels in two subjects each are proposed as 1 mg/kg, 3 mg/kg, 10 mg/kg and 30 mg/kg. GSK2315698 will be administered at variable dosed until the concentration of the SAP mAb has fallen below 100 ng/mL.
Part B Arm	Experimental	Drug: GSK2398852, Drug: GSK2315698The precise selection of numbers of subjects and dose levels in Part B will be informed by the results from Part A.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Subject has been medically diagnosed with systemic amyloidosis and falls into one of the patient groups (small to moderate amyloid load involving the spleen for Part A; moderate to large amyloid load involving the spleen (to a moderate/large extent) for Part A (following agreement from external safety committee); moderate to large amyloid load involving the spleen and liver (spleen involved to a moderate/large extent) for Part A extension (if required); and moderate to large amyloid load involving the spleen (and liver in subset of subjects only) for Part B).
Alanine aminotransferase (ALT) <3x upper limit of normal (ULN) and bilirubin <1.5x ULN (isolated bilirubin >1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Male or female between 18 and 70 years of age inclusive, at the time of signing the informed consent.
Subject is ambulant and capable of attending for the study visit schedule.
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Key exclusion criteria (17 listed)

A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
The subject has participated in a clinical trial and has received an investigational therapeutic product (unlicensed) within the following time period prior to the first dosing day in the current study: 3 months, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). This timeframe will not apply to short term administration of GSK2315698 in study CPH114527.
Pregnant females as determined by positive serum or urine human chorionic gonadotropin (hCG) test at screening or prior to dosing.
Lactating females.
Estimated glomerular filtration rate (GFR)<30 milliliter (mL)/minute (min) [<60 mL/min for the first 4 subjects to be enrolled]

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GSK2398852Unit dose strength: 100 mg/mL provided as 1 mL solution per vial. GSK2398852 dosage levels variable with the proposed starting dose level of GSK2398852 as 5 mg [approximately equivalent to 0.1 mg/ kg]. The next escalation dose levels are proposed as 1 mg/kg, 3 mg/kg, 10 mg/kg and 30 mg/kg.	Drug	Part A Arm, Part B Arm
GSK2315698Unit dose strength: 200 mg/mL stock to be diluted. GSK2315698 will be administered at variable dosed until the concentration of the serum amyloid P component monoclonal antibody (SAP mAb) has fallen below 100 ng/mL.	Drug	Part A Arm, Part B Arm

Primary outcome

Safety of GSK2398852 as assessed by number of subjects with AEs in Part A and in Part B
Time frame: Continuous throughout the study
Adverse events (AEs) will be collected from the start of Study Treatment and until the follow-up contact.
Safety of GSK2398852 as assessed by clinical laboratory tests in Part A and in Part B
Time frame: At scheduled intervals upto Day 42 in each Part.
Safety data will include assessments of clinical laboratory tests (hematology, clinical chemistry and urinalysis).
Safety of GSK2398852 as assessed by vital signs measurements in Part A and in Part B
Time frame: At scheduled intervals upto Day 42 in each Part.
Safety data will include measurements of vital signs (semi supine systolic and diastolic blood pressure, pulse rate and temperature measured orally).
Safety of GSK2398852 as assessed by ECG readings in Part A and in Part B
Time frame: At scheduled intervals upto Day 42 in each Part.
Safety data will include single 12-lead electrocardiogram (ECG) readings obtained at each timepoint during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals.
PK profile of GSK2315698 and GSK2398852 in Part A and in Part B
Time frame: In Part A and Part B on Day -2, Day 1 (pre-dose, 1 hour [hr], 2 hr, 3 hr, 4 hr, 8 hr, 12 hr), Day 2, Day 3, Day 4, Day 6, Day 14, Day 21, Day 42
Pharmacokinetic (PK) profile GSK2315698 and GSK2398852 was performed to evaluate PK of single doses of GSK2398852 and GSK2315698 when co-administered.
Dose response of single doses of GSK2398852 when co-administered with GSK2315698 in Part B
Time frame: Baseline, Day 6, Day 14 and Day 42 in Part B.
The main measure of dose response will be determined by information from part A (and Part A extension if required). The options are: -Volume of distribution of gadolinium in the spleen as a measure of amyloid load (EqMRI); and -Liver histology examination for presence of giant cells, activation of macrophages, and amyloid clearance.

2 secondary outcomes

SAP concentrations measurement
Time frame: Baseline, Day -3, Day -2, Day -1, Day 42 in each Part.
Measurement of anti-drug antibodies before and after treatment with GSK2398852
Time frame: Day 1 pre-dose, Day 21, Day 42 in each Part.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
Derived from this study: PubMed 35810311Richards D, Millns H, Cookson L, Lukas MA. An observational, non-interventional study for the follow-up of patients with amyloidosis who received miridesap followed by dezamizumab in a phase 1 study. Orphanet J Rare Dis. 2022 Jul 9;17(1):259. doi: 10.1186/s13023-022-02405-7.
Derived from this study: PubMed 29298867Richards DB, Cookson LM, Barton SV, Liefaard L, Lane T, Hutt DF, Ritter JM, Fontana M, Moon JC, Gillmore JD, Wechalekar A, Hawkins PN, Pepys MB. Repeat doses of antibody to serum amyloid P component clear amyloid deposits in patients with systemic amyloidosis. Sci Transl Med. 2018 Jan 3;10(422):eaan3128. doi: 10.1126/scitranslmed.aan3128.
Derived from this study: PubMed 26176329Richards DB, Cookson LM, Berges AC, Barton SV, Lane T, Ritter JM, Fontana M, Moon JC, Pinzani M, Gillmore JD, Hawkins PN, Pepys MB. Therapeutic Clearance of Amyloid by Antibodies to Serum Amyloid P Component. N Engl J Med. 2015 Sep 17;373(12):1106-14. doi: 10.1056/NEJMoa1504942. Epub 2015 Jul 15.
Results for study 115570 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK2398852 and GSK2315698 in people with Amyloidosis, run by GlaxoSmithKline at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of GSK2398852 as assessed by number of subjects with AEs in Part A and in Part B (time frame: Continuous throughout the study). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01777243, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.