HealthyPhase 1NCT02045979

Pharmacokinetics and Safety in Healthy Volunteers

A Phase 1 study testing BI 695501, adalimumab-EU source and adalimumab-US source in people with Healthy, run by Boehringer Ingelheim at 3 sites in 2 countries.

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

Investigate the pharmacokinetics, safety and tolerability of BI695501 and to establish pharmacokinetic similarity of BI 695501 to adalimumab. Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 695501, adalimumab-EU source and adalimumab-US source
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 327 participants
Where: 3 sitesin 2 countries
Study dates: 31 Jan 2014to 20 Jun 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy males according to the following criteria:
Based upon a complete medical history, including the physical examination, vital signs (blood pressure [BP] and pulse rate [PR]), 12-lead electrocardiogram (ECG), and clinical laboratory tests;
Age-greater than or equal to 18 years and less than or equal to 55 years;
Body mass index (BMI) =18.5 to =29.9 kg/m2; and
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation.

Who cannot join

Any clinically relevant abnormal finding of the medical examination (including blood pressure (BP), pulse rate (PR), and electrocardiogram (ECG) deviating from normal and of clinical relevance;
Any evidence of a clinically relevant previous or concomitant disease as judged by the investigator including gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal disorders, or diseases of the central nervous system (such as epilepsy), psychiatric disorders, or neurological disorders;
History of relevant orthostatic hypotension, fainting spells, or blackouts;
Chronic or relevant acute infections. A negative result for human immunodeficiency virus (HIV), Hepatitis B (Hep B), and hepatitis C (Hep C) is required for participation;
History of relevant allergy/hypersensitivity (including allergy to drug or its excipients);
Intake of prescribed or over-the-counter drugs with a long half-life (greater than 24 hours) within at least one month or at least 5 half-lives of the respective drug (whichever is longer) prior to administration or during the trial;

Show all 23Show fewer

Previous exposure of a biologic drug;
Use of drugs which might reasonably influence the results of the trial prior to dosing and at any time during the trial;
Intake of an investigational drug in another trial within two months prior to intake of study medication in this trial or intake of an investigational drug during the course of this trial;
Smoker (greater than 10 cigarettes or greater than 3 cigars or greater than 3 pipes/day);
Inability to refrain from smoking during days of confinement at the trial site;
History of alcohol abuse (estimated average more than 4 units/day);
Unwillingness/inability to refrain from intake of alcoholic beverages from 48 hours prior to the study medication administration and until Day 7 post study medication administration;
Unwillingness/inability to limit alcohol intake to a maximum of three units per day until e.o.s.;
Current drug abuse;
Blood donation (more than 100 mL within four weeks prior to administration of the study medication or during the trial);
Vigorous exercise 72 hours prior to dosing. Unwilling to avoid vigorous exercise for 7 days post dosing. Contact sport should be avoided during the entire study;
Any out-of-range laboratory values considered clinically significant by the investigator; subjects with creatine kinase (CK) values three times the upper limit of normal (ULN) at Day -1 are excluded from participation;
Subjects considered unsuitable for inclusion by the investigator (e.g., inability to understand and comply with the study requirements or presence of any condition which, in the opinion of the investigator, would not allow safe participation in the study); or
Inability to comply with dietary regimen of trial site.
Subjects with known Human immunodeficiency virus (HIV), Acquired Immunodeficiency Syndrome, other clinically significant immunological disorders, or auto-immune disorders, (e.g., Rheumatoid arthritis (RA), lupus erythematosus, scleroderma, etc.);
Subject has received a live or attenuated vaccine within 12 weeks prior to enrolling in the trial; or
Positive finding in Interferon-gamma-release assay testing (IGRA-T). In cases where at the screening visit the IGRA result is indeterminate, the subject will have a PPD skin test performed, provided that the screening period timeframe can be maintained. If not, the subject will not be enrolled in this study.

Trial locations and contacts

3 sites in 2 countries.

Country

City, postcode or hospital

3 sites in 2 countries

New Zealand2 sites

1297.8.2001 Boehringer Ingelheim Investigational Site
Auckland
1297.8.2002 Boehringer Ingelheim Investigational Site
Christchurch

Other trials in New Zealand

Belgium1 site

1297.8.1001 Boehringer Ingelheim Investigational Site
Antwerp

Other trials in Belgium

About this study

Official title: Pharmacokinetics and Safety of BI 695501 in Healthy Subjects: a Randomized, Double-blind, Single Dose, Parallel-arm, Active Comparator Clinical Phase I Study

Investigate the pharmacokinetics, safety and tolerability of BI695501 and to establish pharmacokinetic similarity of BI 695501 to adalimumab.

Conditions: Healthy
Being tested: BI 695501, adalimumab-EU source, adalimumab-US source

What participants receive

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

BI 695501Drug
BI 695501 single s.c. injection
adalimumab-EU sourceDrug
adalimumab-EU source single s.c. injection
adalimumab-US sourceDrug
adalimumab-US source single s.c. injection.

Study groups in NCT02045979
Study group	Role	What they receive
BI 695501	Experimental	Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing BI 695501 Receives: Drug: BI 695501
adalimumab-EU source	Active comparator	Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing adalimumab-EU source Receives: Drug: adalimumab-EU source
adalimumab-US source	Active comparator	Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing adalimumab-US source Receives: Drug: adalimumab-US source

What is being measured

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

Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞) of BI 695501, US-licensed Humira® or EU-approved Humira®
Area under the concentration time curve (AUC) from time zero to infinity (AUC 0-∞) of BI 695501, US-licensed Humira® or EU-approved Humira®.
Abbreviation used: Pharmacokinetics (PK).
Measured: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing.
Area Under the Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC0-tz) of BI 695501, US-licensed Humira® or EU-approved Humira®
Area under the concentration time curve from time zero to last measurable concentration (AUC0-tz) of BI 695501, US-licensed Humira® or EU-approved Humira®.
Measured: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing.
Maximum Concentration (Cmax) of BI 695501, US-licensed Humira® or EU-approved Humira®
Maximum concentration (Cmax) of BI 695501, US-licensed Humira® or EU-approved Humira®.
Measured: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing.

Secondary outcomes (7)

AUC (0-168) of BI 695501, US-licensed Humira® or EU-approved Humira®
Area under the concentration time curve (AUC) from time zero to 168 hours post dose (AUC 0-168) of BI 695501, US-licensed Humira® or EU-approved Humira®.
PK is the abbreviation for Pharmacokinetic(s).
Measured: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168 hours post dosing
AUC (0-312) of BI 695501, US-licensed Humira® or EU-approved Humira®
Area under the concentration time curve (AUC) from time zero to 312 hours post dose (AUC 0-312) of BI 695501, US-licensed Humira® or EU-approved Humira®.
PK is the abbreviation for Pharmacokinetic(s).
Measured: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312 hours post dosing
AUC (0-480) of BI 695501, US-licensed Humira® or EU-approved Humira®
Area under the concentration time curve (AUC) from time zero to 480 hours post dose (AUC 0-480) of BI 695501, US-licensed Humira® or EU-approved Humira®.
PK is the abbreviation for Pharmacokinetic(s).
Measured: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480 hours post dosing
AUC (0-648) of BI 695501, US-licensed Humira® or EU-approved Humira®
Area under the concentration time curve (AUC) from time zero to 648 hours post dose (AUC 0-648) of BI 695501, US-licensed Humira® or EU-approved Humira®.
PK is the abbreviation for Pharmacokinetic(s).
Measured: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648 hours post dosing
AUC (0-1032) of BI 695501, US-licensed Humira® or EU-approved Humira®
Area under the concentration time curve (AUC) from time zero to 1032 hours post dose (AUC 0-1032) of BI 695501, US-licensed Humira® or EU-approved Humira® PK is the abbreviation for Pharmacokinetic(s).
Measured: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032 hours post dosing
AUC 0-∞,Obs of BI 695501, US-licensed Humira® or EU-approved Humira®
Area under the concentration time curve (AUC) from time zero to infinity (AUC 0-∞) based on the last observed concentration at time of last measureable concentration (tz) of BI 695501, US-licensed Humira® or EU-approved Humira®.
PK is the abbreviation of Pharmacokinetic(s).
Measured: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing.
Number (Proportion) of Subjects With Drug Related Adverse Events
All events with an onset after the first administration of the trial medication up to a period of 70 days after the last administration of the trial medication (i.e., end of the REP) was assigned to the treatment phase for evaluation and was defined as a treatment-emergent AE (TEAE). A treatment-related AE was defined as any TEAE assessed by the investigator as related to the trial medication.
All safety data were displayed and analyzed using descriptive statistical methods. No formal inferential analyses were planned for safety comparisons. Tabulations of frequencies and proportions, as appropriate were used for the evaluation of categorical (qualitative) data, and tabulations of descriptive statistics were used to analyze continuous (quantitative) data.
Measured: Day 1 through Day 71

Timeline

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

31 Jan 201420 Jun 2014

First posted27 Jan 2014 (estimated)
Study start31 Jan 2014
Primary completion20 Jun 2014
Study completion20 Jun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe 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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 327 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02045979
Sponsor's protocol ID: 1297.8
Other IDs: 2013-003722-84
Status last verified: Sep 2017
First submitted: 23 Jan 2014
Last updated: 20 Jun 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

Huizinga TWJ, Torii Y, Muniz R. Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. Rheumatol Ther. 2021 Mar;8(1):41-61. doi: 10.1007/s40744-020-00259-8. Epub 2020 Dec 1.
PubMed 33263165
Kang J, Eudy-Byrne RJ, Mondick J, Knebel W, Jayadeva G, Liesenfeld KH. Population pharmacokinetics of adalimumab biosimilar adalimumab-adbm and reference product in healthy subjects and patients with rheumatoid arthritis to assess pharmacokinetic similarity. Br J Clin Pharmacol. 2020 Nov;86(11):2274-2285. doi: 10.1111/bcp.14330. Epub 2020 Jun 11.
PubMed 32363771
Wynne C, Altendorfer M, Sonderegger I, Gheyle L, Ellis-Pegler R, Buschke S, Lang B, Assudani D, Athalye S, Czeloth N. Bioequivalence, safety and immunogenicity of BI 695501, an adalimumab biosimilar candidate, compared with the reference biologic in a randomized, double-blind, active comparator phase I clinical study (VOLTAIRE(R)-PK) in healthy subjects. Expert Opin Investig Drugs. 2016 Dec;25(12):1361-1370. doi: 10.1080/13543784.2016.1255724.
PubMed 27813422

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 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics and Safety of BI 695501 in Healthy Subjects: a Randomized, Double-blind, Single Dose, Parallel-arm, Active Comparator Clinical Phase I Study
ClinicalTrials.gov ID: NCT02045979
Acronym / sponsor ID: 1297.8
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 327 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 31 Jan 2014 (actual)
Primary completion: 20 Jun 2014 (actual)
Study completion: 20 Jun 2014 (actual)
First posted: 27 Jan 2014 (estimated)
Results: Posted 20 Jun 2018

Clinical summary

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

Investigate the pharmacokinetics, safety and tolerability of BI695501 and to establish pharmacokinetic similarity of BI 695501 to adalimumab.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 3

Arm	Type	Receives
BI 695501	Experimental	Drug: BI 695501Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing BI 695501
adalimumab-EU source	Active comparator	Drug: adalimumab-EU sourceSubject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing adalimumab-EU source
adalimumab-US source	Active comparator	Drug: adalimumab-US sourceSubject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing adalimumab-US source

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Based upon a complete medical history, including the physical examination, vital signs (blood pressure [BP] and pulse rate [PR]), 12-lead electrocardiogram (ECG), and clinical laboratory tests;
Age-greater than or equal to 18 years and less than or equal to 55 years;
Body mass index (BMI) =18.5 to =29.9 kg/m2; and
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation.

Key exclusion criteria (23 listed)

Any clinically relevant abnormal finding of the medical examination (including blood pressure (BP), pulse rate (PR), and electrocardiogram (ECG) deviating from normal and of clinical relevance;
Any evidence of a clinically relevant previous or concomitant disease as judged by the investigator including gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal disorders, or diseases of the central nervous system (such as epilepsy), psychiatric disorders, or neurological disorders;
History of relevant orthostatic hypotension, fainting spells, or blackouts;
Chronic or relevant acute infections. A negative result for human immunodeficiency virus (HIV), Hepatitis B (Hep B), and hepatitis C (Hep C) is required for participation;
History of relevant allergy/hypersensitivity (including allergy to drug or its excipients);

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
BI 695501BI 695501 single s.c. injection	Drug	BI 695501
adalimumab-EU sourceadalimumab-EU source single s.c. injection	Drug	adalimumab-EU source
adalimumab-US sourceadalimumab-US source single s.c. injection.	Drug	adalimumab-US source

Primary outcome

Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞) of BI 695501, US-licensed Humira® or EU-approved Humira®
Time frame: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing.
Area under the concentration time curve (AUC) from time zero to infinity (AUC 0-∞) of BI 695501, US-licensed Humira® or EU-approved Humira®. Abbreviation used: Pharmacokinetics (PK).
Area Under the Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC0-tz) of BI 695501, US-licensed Humira® or EU-approved Humira®
Time frame: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing.
Area under the concentration time curve from time zero to last measurable concentration (AUC0-tz) of BI 695501, US-licensed Humira® or EU-approved Humira®.
Maximum Concentration (Cmax) of BI 695501, US-licensed Humira® or EU-approved Humira®
Time frame: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing.
Maximum concentration (Cmax) of BI 695501, US-licensed Humira® or EU-approved Humira®.

7 secondary outcomes

AUC (0-168) of BI 695501, US-licensed Humira® or EU-approved Humira®
Time frame: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168 hours post dosing
AUC (0-312) of BI 695501, US-licensed Humira® or EU-approved Humira®
Time frame: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312 hours post dosing
AUC (0-480) of BI 695501, US-licensed Humira® or EU-approved Humira®
Time frame: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480 hours post dosing
AUC (0-648) of BI 695501, US-licensed Humira® or EU-approved Humira®
Time frame: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648 hours post dosing
AUC (0-1032) of BI 695501, US-licensed Humira® or EU-approved Humira®
Time frame: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032 hours post dosing
AUC 0-∞,Obs of BI 695501, US-licensed Humira® or EU-approved Humira®
Time frame: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing.
Number (Proportion) of Subjects With Drug Related Adverse Events
Time frame: Day 1 through Day 71

Results and safety

Results posted to the registry on 20 Jun 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BI 695501	108	106
US-licensed Humira®	108	107
EU-approved Humira®	108	107

Primary outcome: Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞) of BI 695501, US-licensed Humira® or EU-approved Humira®

Time frame: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing.. Geometric mean (Geometric Coefficient of Variation). Unit: microgram (µg)*hour (h)/millilitre (mL)

Measure	BI 695501 n = 106	US-licensed Humira® n = 105	EU-approved Humira® n = 105
Value	2630 (52.4)	2470 (51.2)	2650 (38.5)

BI 695501 vs US-licensed Humira®: ratio of the geometric means: 108.62 (90% CI 98.50 to 119.79)
BI 695501 vs EU-approved Humira®: ratio of the geometric means: 101.27 (90% CI 92.45 to 110.94)
US-licensed Humira® vs EU-approved Humira®: ratio of the geometric means: 94.02 (90% CI 86.01 to 102.78)

Population analysed: PK analysis set consisted of all randomized subjects who received the single dose of trial medication (BI 695501, US-licensed - or EU-approved Humira®), had at least one evaluable primary PK endpoint and were without important protocol deviations or violations thought to significantly affect the PK of BI 695501, US-licensed - or EU-approved Humira®

Primary outcome: Area Under the Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC0-tz) of BI 695501, US-licensed Humira® or EU-approved Humira®

Measure	BI 695501 n = 106	US-licensed Humira® n = 107	EU-approved Humira® n = 106
Value	2440 (47.8)	2300 (45.1)	2480 (33.5)

BI 695501 vs US-licensed Humira®: ratio of the geometric means: 107.32 (90% CI 98.49 to 116.94)
BI 695501 vs EU-approved Humira®: ratio of the geometric means: 99.93 (90% CI 92.15 to 108.37)
US-licensed Humira® vs EU-approved Humira®: ratio of the geometric means: 93.66 (90% CI 86.76 to 101.11)

Population analysed: The PK analysis set.

Primary outcome: Maximum Concentration (Cmax) of BI 695501, US-licensed Humira® or EU-approved Humira®

Measure	BI 695501 n = 107	US-licensed Humira® n = 108	EU-approved Humira® n = 107
Value	3.907 (34.1)	3.900 (34.5)	4.140 (30.4)

BI 695501 vs US-licensed Humira®: ratio of the geometric means: 100.85 (90% CI 95.15 to 106.88)
BI 695501 vs EU-approved Humira®: ratio of the geometric means: 96.39 (90% CI 91.06 to 102.03)
US-licensed Humira® vs EU-approved Humira®: ratio of the geometric means: 95.93 (90% CI 90.83 to 101.33)

Population analysed: The PK analysis set.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 (first administration of trial medication) until day 71. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BI 695501	3 of 108 (2.8%)	51 of 108 (47.2%)	Not reported
US-licensed Humira®	3 of 108 (2.8%)	52 of 108 (48.1%)	Not reported
EU-approved Humira®	2 of 108 (1.9%)	51 of 108 (47.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33263165Huizinga TWJ, Torii Y, Muniz R. Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. Rheumatol Ther. 2021 Mar;8(1):41-61. doi: 10.1007/s40744-020-00259-8. Epub 2020 Dec 1.
Derived from this study: PubMed 32363771Kang J, Eudy-Byrne RJ, Mondick J, Knebel W, Jayadeva G, Liesenfeld KH. Population pharmacokinetics of adalimumab biosimilar adalimumab-adbm and reference product in healthy subjects and patients with rheumatoid arthritis to assess pharmacokinetic similarity. Br J Clin Pharmacol. 2020 Nov;86(11):2274-2285. doi: 10.1111/bcp.14330. Epub 2020 Jun 11.
Derived from this study: PubMed 27813422Wynne C, Altendorfer M, Sonderegger I, Gheyle L, Ellis-Pegler R, Buschke S, Lang B, Assudani D, Athalye S, Czeloth N. Bioequivalence, safety and immunogenicity of BI 695501, an adalimumab biosimilar candidate, compared with the reference biologic in a randomized, double-blind, active comparator phase I clinical study (VOLTAIRE(R)-PK) in healthy subjects. Expert Opin Investig Drugs. 2016 Dec;25(12):1361-1370. doi: 10.1080/13543784.2016.1255724.
Related InfoLink provided by the sponsor.

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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

3 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 695501, adalimumab-EU source and adalimumab-US source in people with Healthy, run by Boehringer Ingelheim at 3 sites in 2 countries.

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 5 inclusion and 23 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 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in New Zealand, Belgium. 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?

Yes. Results are posted in the registry (first posted 20 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞) of BI 695501, US-licensed Humira® or EU-approved Humira® (time frame: at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing.). The study lists 3 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 NCT02045979, 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 20 Jun 2018.