PsoriasisPhase 1NCT02156466

Multiple Ascending Dose Trial of MSB0010841 (Anti-IL17A/F Nanobody) in Psoriasis Subjects

A Phase 1 study testing MSB0010841 in people with Psoriasis, run by Merck KGaA, Darmstadt, Germany at 1 site in Germany.

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

This is a multicenter, Phase 1, randomized, double-blind, placebo-controlled trial in subjects with moderate to severe psoriasis to assess the safety, tolerability, immunogenicity, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of multiple subcutaneous ascending doses of MSB0010841 (Anti-interleukin-17A/F… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Psoriasis
What is being tested?: MSB0010841
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 41 participants
Where: 1 siteGermany
Study dates: Aug 2014to Aug 2015
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Chronic plaque psoriasis for at least 6 months before screening
Greater than or equal to (>=) 10% of BSA with plaques
Psoriasis Area and Severity Index (PASI) >=12
Static Physician's Global Assessment (sPGA) >=3 (where scores range from 0 [clear of disease] to 5 [severe disease]) at the screening and baseline visits
Other protocol defined inclusion criteria could apply

Who cannot join

Any condition, including protocol-specified laboratory findings and findings in the medical history or in the pre-trial assessments which in the Investigator's opinion constitutes a risk or a contraindication for the subject's participation in the trial or that could interfere with the trial objectives, conduct or evaluation
Currently having a form of non-plaque psoriasis as specified in the protocol
Drug induced psoriasis
Biological treatments as specified in the protocol, within 3 months prior to Day 1
Systemic immunosuppressants or phototherapy as specified in the protocol, within 1 month prior to Day 1
Use of anti-coagulant medications and/or antiplatelet medications as defined in the protocol

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Use of aspirin as defined in the protocol
Topical corticosteroid treatments other than low-strength or lower-mid strength corticosteroids on the face, scalp, axillae, and/or groin within 1 month prior to Day 1
Any previous treatment with an agent targeting interleukin (IL)-17, IL-12 and/or IL-23 as specified in the protocol
Other protocol defined exclusion criteria could apply

Trial locations and contacts

1 site in 1 country.

Germany1 site

Please contact the Merck KGaA Communication Center
Darmstadt

Other trials in Germany

About this study

Official title: Multicenter, Phase I, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability, Immunogenicity, Pharmacokinetics, Pharmacodynamics and Efficacy of Multiple Ascending Doses of Subcutaneous MSB0010841 (Anti-IL17A/F Nanobody) in Male and Female Subjects With Moderate to Severe Psoriasis

Conditions: Psoriasis
Being tested: MSB0010841, Placebo
Keywords: Psoriasis, MSB0010841, Anti-IL17A/F Nanobody, M1095
Medical subject headings: Psoriasis

What participants receive

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

MSB0010841Drug
Also called Anti-IL-17A/F Nanobody, M1095
MSB0010841(Anti- IL-17A/F Nanobody) will be administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
MSB0010841Drug
Also called Anti-IL-17A/F Nanobody, M1095
MSB0010841 will be administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
MSB0010841Drug
Also called Anti-IL-17A/F Nanobody, M1095
MSB0010841 will be administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
MSB0010841Drug
Also called Anti-IL-17A/F Nanobody, M1095
MSB0010841 will be administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
PlaceboDrug
Placebo matched to MSB0010841 will be administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.

Study groups in NCT02156466
Study group	Role	What they receive
MSB0010841 30 mg	Experimental	Not described Receives: Drug: MSB0010841
MSB0010841 60 mg	Experimental	Not described Receives: Drug: MSB0010841
MSB0010841 120 mg	Experimental	Not described Receives: Drug: MSB0010841
MSB0010841 240 mg	Experimental	Not described Receives: Drug: MSB0010841
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. TEAEs were the AEs occurring or worsening after treatment administration.
Measured: Baseline up to Day 85
Number of Subjects With Local Injection Site Reactions (ISRs)
The injection site was assessed by the Principal Investigator (PI) or his/her designee for local reactions such as redness, swelling, indurations or bruising, and by the subject for itching. Redness and bruising were scaled as None (no visible redness or bruising present); Mild (less than or equal to [<=] 2.0 centimeters [cm] redness or bruising area); Moderate (greater than [>] 2 to <=5.0 cm redness or bruising area); Severe (>5.0 cm redness or bruising area). Swelling was scaled as None (no swelling detected); Mild (palpable 'firmness' only); Moderate (<= 4 cm swelling); Severe (>4 cm swelling). Induration was scaled as None (no induration); Mild (able to move skin parallel to plane (sliding) and perpendicular to skin (pinching up); Moderate (able to slide skin, unable to pinch skin); Severe (unable to slide or pinch skin). Itching was scaled as No itching; Mild itching; Moderate itching and Severe itching. Subjects who reported any of the local ISRs were reported.
Measured: Day 1, 2,8, 15, 16, 22, 29, 30, 36, 43
Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)
Subjects were asked to assess their severity of injection site pain on a 100 millimeter (mm) VAS, where 0 = no pain and 100 = worst possible pain. Mean of amount of pain was calculated for the subjects having a value > 0. Maximum values per subjects (over injection site areas) are used for counting the amount of pain at injection site. Maximum pain scores recorded among all participants analysed in each arm are reported for each time point.
Measured: Day 1, 2, 8, 15, 16, 22, 29, 30, 36, 43
Percentage of Subjects With Anti-MSB0010841 Binding Antibodies (Anti-Drug Antibodies [ADA])
Data were presented for MSB0010841 combined group and placebo.
Measured: Baseline up to Day 85
Levels of Anti-MSB0010841 Antibody Titers
Measured: Day 8, 15 (pre-dose), 22, 29 (pre-dose), 36, 43, 63 and 85
Levels of Pre-existing Anti-MSB0010841 Antibody Titers
Measured: Pre-dose on Day 1
MSB0010841 Serum Concentration Over Time After First Dose
Measured: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)
MSB0010841 Serum Concentration Over Time After Second Dose
Measured: 0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15)
MSB0010841 Serum Concentration Over Time After Third Dose
Measured: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post First Dose of MSB0010841
Area under the serum concentration-time curve (AUC) from time zero to the last sampling time point at which the concentration is at or above lower limit of quantification (LLOQ).
Measured: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post Third Dose of MSB0010841
Area under the serum concentration-time curve (AUC) from time zero to the last sampling time point at which the concentration is at or above LLOQ.
Measured: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post First Dose of MSB0010841
Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours).
Measured: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)
Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post Third Dose of MSB0010841
Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours).
Measured: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-third dose (Day 29)
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC 0-inf) Post Third Dose of MSB0010841
Area under the serum concentration-time curve from time zero to infinity (AUC0-inf). AUC0-infcalculated as AUC0-t + AUCextra. AUCextra represents the extrapolated part of AUC0-inf calculated by Clast calc/λz, where Clast calc is the calculated concentration at the last sampling time point at which the measured concentration is at or above LLOQ and λz is the terminal rate constant determined from the terminal slope of the log transformed concentration curve using linear regression on terminal data points of the curve.
Measured: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Observed Serum Concentration Immediately Before First Dose (Cpre) of MSB0010841
The observed serum concentration immediately before the first dose.
Measured: Pre-dose (0 hours) on Day 1
Observed Serum Concentration Immediately Before Third Dose (Cpre) of MSB0010841
The observed serum concentration immediately before the third dose.
Measured: Pre-dose (0 hours) on Day 29
Minimum Concentration Observed (Cmin) During First Dosing Interval of MSB0010841
The observed minimum serum concentration determined directly from the serum concentration-time profile of each subject.
Measured: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)
Minimum Concentration Observed (Cmin) During Third Dosing Interval of MSB0010841
The observed minimum serum concentration determined directly from the serum concentration-time profile of each subject.
Measured: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Maximum Concentration Observed (Cmax) Post First Dose of MSB0010841
Measured: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)
Maximum Concentration Observed (Cmax) Post Third Dose of MSB0010841
Measured: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Average Concentration (Cav) Post First Dose of MSB0010841
Cav was calculated by AUCtau/tau. Where tau is the dosing interval (336 hours).
Measured: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)
Average Concentration (Cav) Post Third Dose of MSB0010841
Cav was calculated by AUCtau/tau. Where tau is the dosing interval (336 hours).
Measured: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Mean Residence Time (MRT0-t) Post First Dose of MSB0010841
MRT is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as AUMC(0-t)/AUC(0-t) where AUMC(0-t) is area under the plasma concentration-time first moment curve from time zero to time t (336 hours) and AUC(0-t) is the area under the plasma concentration-time curve from time zero to tome t (336 hours).
Measured: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)
Mean Residence Time (MRT0-t) Post Third Dose of MSB0010841
MRT is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as AUMC(0-t)/AUC(0-t) where AUMC(0-t) is area under the plasma concentration-time first moment curve from time zero to time t (336 hours) and AUC(0-t) is the area under the plasma concentration-time curve from time zero to tome t (336 hours).
Measured: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-third dose (Day 29)
Mean Residence Time of Drug in the Body From Time Zero Extrapolated to Infinity (MRT(0-inf) Post Third Dose of MSB0010841
Mean residence time of drug in the body from time zero extrapolated to infinity, based on the last predicted concentration at tlast.
Measured: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Time to Reach Maximum Observed Concentration (Tmax) Post First Dose of MSB0010841
Measured: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)
Time to Maximum Observed Concentration (Tmax) Post Second Dose of MSB0010841
Measured: 0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15)
Time to Reach Maximum Observed Concentration (Tmax) Post Third Dose of MSB0010841
Measured: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Apparent Terminal Half-life (t1/2) Post Third Dose of MSB0010841
Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (*) 2/ λz, where 'λz' is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Measured: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Terminal Rate Constant (λz) Post Third Dose of MSB0010841
Terminal rate constant was determined from the terminal slope of the logtransformed concentration curve using linear regression on terminal data points of the curve
Measured: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Apparent Clearance (CL/f) Post Third Dose of MSB0010841
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed.
Measured: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Apparent Volume of Distribution During Terminal Phase (Vz/f) Post Third Dose of MSB0010841
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by elimination rate constant [λz]) following first dose and Dose/(AUCtau multiplied by λz) after third dose.
Measured: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Percentage Peak-Trough Fluctuation (PTF) Post First Dose of MSB0010841
The peak trough fluctuation within one dosing interval, calculated as PTF (%) = ([Cmax - Cmin]/Cav ) multiplied by 100
Measured: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)
Percentage Peak-Trough Fluctuation (PTF) Post Third Dose of MSB0010841
The peak trough fluctuation within one dosing interval, calculated as PTF (%) = ([Cmax - Cmin]/Cav ) multiplied by 100
Measured: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Accumulation Ratio of Cmax (Racc (Cmax))
Accumulation ratio for Cmax was calculated as Cmax, after third dose / Cmax, after first dose.
Measured: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) and 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Accumulation Ratio of AUC (Racc(AUC))
Accumulation ratio for AUC, calculated as area under the serum concentration-time curve within one complete dosing interval at third dose divided by area under the serum concentration-time curve within one complete dosing interval at first dose.
Measured: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) and 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Maximum Observed Concentration (Cmax) Post Second Dose of MSB0010841
Measured: 0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15)
Observed Serum Concentration Immediately Before Second Dose (Cpre) of MSB0010841
The observed serum concentration immediately before second dose.
Measured: Pre-dose (0 hours) on Day 15

Secondary outcomes (5)

Percentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score
PASI: a physician assessed index that measured psoriasis severity and evaluated erythema, infiltration, and desquamation (scaling) on different body areas including the head, upper extremities, the trunk, and lower extremities. T Erythema, infiltration, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. PASI score ranged from 0 to 72, with higher scores reflecting greater disease severity. PASI 50% or 75% was defined as the percentage of participants who achieved >=50 or 75% improvement in PASI score from Baseline.
Measured: Baseline up to Day 85
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43
PASI: a physician assessed index that measured psoriasis severity and evaluated erythema, infiltration, and desquamation (scaling) on different body areas including the head, upper extremities, the trunk, and lower extremities. T Erythema, infiltration, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. PASI score ranged from 0 to 72, with higher scores reflecting greater disease severity. PASI 50% or 75% was defined as the percentage of subjects who achieved >=50 or 75% improvement in PASI score from Baseline.
Measured: Baseline, Day 43
Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline
The static Physician's Global Assessment (sPGA) scale rated the investigator's overall clinical assessment of a subjects plaque thickness, erythema, and scaling on a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (majority of plaques have severe thickness, erythema, and scale). To assign a sPGA score, the investigator examined all psoriatic lesions and assigned a severity score ranging from 0 to 5 for thickness, erythema, and scaling. Scores for thickness, erythema, and scaling are summed and the mean of these 3 scores equals the overall sPGA score. Overall sPGA score ranged from 0 to 5, where lower scores indicate clinical improvement. Percentage of subjects who achieved a sPGA rating of 0 (clear) or 1 (minimal) and had at Least 2 level reduction from Baseline score were reported.
Measured: Day 8, 15, 22, 29, 36, 43, 50, 85
Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85
The BSA is the physician's evaluation for the extent of disease. The entire body area is divided into 4 districts: head, upper limbs, trunk and lower limbs to which corresponds the 10%, 20%, 30% and 40% of the entire body surface respectively. The investigator assesses the percentage of the subjects' body surface area affected by psoriasis in each district. The final affected BSA value is the sum of the percentage of each district.
Measured: Baseline, Day 8, 15, 22, 29, 36, 43, 50 and 85
Percentage of Subjects With Exacerbation of Psoriasis
Psoriasis exacerbation was defined as either a worsening of 25% over the baseline value of the PASI score (PASI score at any visit >=125% of baseline PASI).
Measured: Baseline up to Day 85

Timeline

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

Aug 2014Aug 2015

First posted5 Jun 2014 (estimated)
Study startAug 2014
Primary completionAug 2015
Study completionAug 2015

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.
Other trials for PsoriasisStudies of the same condition, open and under way.
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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02156466
Sponsor's protocol ID: 200574-003
Other IDs: 2013-005436-18
Status last verified: Nov 2016
First submitted: 23 May 2014
Last updated: 19 Jan 2017
Results posted: Yes, on ClinicalTrials.gov

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?

See locations

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All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter, Phase I, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability, Immunogenicity, Pharmacokinetics, Pharmacodynamics and Efficacy of Multiple Ascending Doses of Subcutaneous MSB0010841 (Anti-IL17A/F Nanobody) in Male and Female Subjects With Moderate to Severe Psoriasis
ClinicalTrials.gov ID: NCT02156466
Acronym / sponsor ID: 200574-003
Conditions: Psoriasis
Keywords: Psoriasis, MSB0010841, Anti-IL17A/F Nanobody, M1095
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
Study start: Aug 2014
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 5 Jun 2014 (estimated)
Results: Posted 19 Jan 2017

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: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
MSB0010841 30 mg	Experimental	Drug: MSB0010841
MSB0010841 60 mg	Experimental	Drug: MSB0010841
MSB0010841 120 mg	Experimental	Drug: MSB0010841
MSB0010841 240 mg	Experimental	Drug: MSB0010841
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

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

Key inclusion criteria (5 listed)

Chronic plaque psoriasis for at least 6 months before screening
Greater than or equal to (>=) 10% of BSA with plaques
Psoriasis Area and Severity Index (PASI) >=12
Static Physician's Global Assessment (sPGA) >=3 (where scores range from 0 [clear of disease] to 5 [severe disease]) at the screening and baseline visits
Other protocol defined inclusion criteria could apply

Key exclusion criteria (10 listed)

Any condition, including protocol-specified laboratory findings and findings in the medical history or in the pre-trial assessments which in the Investigator's opinion constitutes a risk or a contraindication for the subject's participation in the trial or that could interfere with the trial objectives, conduct or evaluation
Currently having a form of non-plaque psoriasis as specified in the protocol
Drug induced psoriasis
Biological treatments as specified in the protocol, within 3 months prior to Day 1
Systemic immunosuppressants or phototherapy as specified in the protocol, within 1 month prior to Day 1

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
MSB0010841Also: Anti-IL-17A/F Nanobody, M1095MSB0010841(Anti- IL-17A/F Nanobody) will be administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.	Drug	MSB0010841 30 mg
MSB0010841Also: Anti-IL-17A/F Nanobody, M1095MSB0010841 will be administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.	Drug	MSB0010841 60 mg
MSB0010841Also: Anti-IL-17A/F Nanobody, M1095MSB0010841 will be administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.	Drug	MSB0010841 120 mg
MSB0010841Also: Anti-IL-17A/F Nanobody, M1095MSB0010841 will be administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.	Drug	MSB0010841 240 mg
PlaceboPlacebo matched to MSB0010841 will be administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.	Drug	Placebo

Primary outcome

Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline up to Day 85
An adverse event (AE) was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. TEAEs were the AEs occurring or worsening after treatment administration.
Number of Subjects With Local Injection Site Reactions (ISRs)
Time frame: Day 1, 2,8, 15, 16, 22, 29, 30, 36, 43
The injection site was assessed by the Principal Investigator (PI) or his/her designee for local reactions such as redness, swelling, indurations or bruising, and by the subject for itching. Redness and bruising were scaled as None (no visible redness or bruising present); Mild (less than or equal to [<=] 2.0 centimeters [cm] redness or bruising area); Moderate (greater than [>] 2 to <=5.0 cm redness or bruising area); Severe (>5.0 cm redness or bruising area). Swelling was scaled as None (no swelling detected); Mild (palpable 'firmness' only); Moderate (<= 4 cm swelling); Severe (>4 cm swelling). Induration was scaled as None (no induration); Mild (able to move skin parallel to plane (sliding) and perpendicular to skin (pinching up); Moderate (able to slide skin, unable to pinch skin); Severe (unable to slide or pinch skin). Itching was scaled as No itching; Mild itching; Moderate itching and Severe itching. Subjects who reported any of the local ISRs were reported.
Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)
Time frame: Day 1, 2, 8, 15, 16, 22, 29, 30, 36, 43
Subjects were asked to assess their severity of injection site pain on a 100 millimeter (mm) VAS, where 0 = no pain and 100 = worst possible pain. Mean of amount of pain was calculated for the subjects having a value > 0. Maximum values per subjects (over injection site areas) are used for counting the amount of pain at injection site. Maximum pain scores recorded among all participants analysed in each arm are reported for each time point.
Percentage of Subjects With Anti-MSB0010841 Binding Antibodies (Anti-Drug Antibodies [ADA])
Time frame: Baseline up to Day 85
Data were presented for MSB0010841 combined group and placebo.
Levels of Anti-MSB0010841 Antibody Titers
Time frame: Day 8, 15 (pre-dose), 22, 29 (pre-dose), 36, 43, 63 and 85
Levels of Pre-existing Anti-MSB0010841 Antibody Titers
Time frame: Pre-dose on Day 1
MSB0010841 Serum Concentration Over Time After First Dose
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)
MSB0010841 Serum Concentration Over Time After Second Dose
Time frame: 0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15)
MSB0010841 Serum Concentration Over Time After Third Dose
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post First Dose of MSB0010841
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)
Area under the serum concentration-time curve (AUC) from time zero to the last sampling time point at which the concentration is at or above lower limit of quantification (LLOQ).
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post Third Dose of MSB0010841
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Area under the serum concentration-time curve (AUC) from time zero to the last sampling time point at which the concentration is at or above LLOQ.
Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post First Dose of MSB0010841
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)
Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours).
Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post Third Dose of MSB0010841
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-third dose (Day 29)
Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours).
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC 0-inf) Post Third Dose of MSB0010841
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Area under the serum concentration-time curve from time zero to infinity (AUC0-inf). AUC0-infcalculated as AUC0-t + AUCextra. AUCextra represents the extrapolated part of AUC0-inf calculated by Clast calc/λz, where Clast calc is the calculated concentration at the last sampling time point at which the measured concentration is at or above LLOQ and λz is the terminal rate constant determined from the terminal slope of the log transformed concentration curve using linear regression on terminal data points of the curve.
Observed Serum Concentration Immediately Before First Dose (Cpre) of MSB0010841
Time frame: Pre-dose (0 hours) on Day 1
The observed serum concentration immediately before the first dose.
Observed Serum Concentration Immediately Before Third Dose (Cpre) of MSB0010841
Time frame: Pre-dose (0 hours) on Day 29
The observed serum concentration immediately before the third dose.
Minimum Concentration Observed (Cmin) During First Dosing Interval of MSB0010841
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)
The observed minimum serum concentration determined directly from the serum concentration-time profile of each subject.
Minimum Concentration Observed (Cmin) During Third Dosing Interval of MSB0010841
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
The observed minimum serum concentration determined directly from the serum concentration-time profile of each subject.
Maximum Concentration Observed (Cmax) Post First Dose of MSB0010841
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)
Maximum Concentration Observed (Cmax) Post Third Dose of MSB0010841
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Average Concentration (Cav) Post First Dose of MSB0010841
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)
Cav was calculated by AUCtau/tau. Where tau is the dosing interval (336 hours).
Average Concentration (Cav) Post Third Dose of MSB0010841
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Cav was calculated by AUCtau/tau. Where tau is the dosing interval (336 hours).
Mean Residence Time (MRT0-t) Post First Dose of MSB0010841
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)
MRT is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as AUMC(0-t)/AUC(0-t) where AUMC(0-t) is area under the plasma concentration-time first moment curve from time zero to time t (336 hours) and AUC(0-t) is the area under the plasma concentration-time curve from time zero to tome t (336 hours).
Mean Residence Time (MRT0-t) Post Third Dose of MSB0010841
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-third dose (Day 29)
MRT is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as AUMC(0-t)/AUC(0-t) where AUMC(0-t) is area under the plasma concentration-time first moment curve from time zero to time t (336 hours) and AUC(0-t) is the area under the plasma concentration-time curve from time zero to tome t (336 hours).
Mean Residence Time of Drug in the Body From Time Zero Extrapolated to Infinity (MRT(0-inf) Post Third Dose of MSB0010841
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Mean residence time of drug in the body from time zero extrapolated to infinity, based on the last predicted concentration at tlast.
Time to Reach Maximum Observed Concentration (Tmax) Post First Dose of MSB0010841
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)
Time to Maximum Observed Concentration (Tmax) Post Second Dose of MSB0010841
Time frame: 0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15)
Time to Reach Maximum Observed Concentration (Tmax) Post Third Dose of MSB0010841
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Apparent Terminal Half-life (t1/2) Post Third Dose of MSB0010841
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (*) 2/ λz, where 'λz' is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Terminal Rate Constant (λz) Post Third Dose of MSB0010841
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Terminal rate constant was determined from the terminal slope of the logtransformed concentration curve using linear regression on terminal data points of the curve
Apparent Clearance (CL/f) Post Third Dose of MSB0010841
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed.
Apparent Volume of Distribution During Terminal Phase (Vz/f) Post Third Dose of MSB0010841
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by elimination rate constant [λz]) following first dose and Dose/(AUCtau multiplied by λz) after third dose.
Percentage Peak-Trough Fluctuation (PTF) Post First Dose of MSB0010841
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)
The peak trough fluctuation within one dosing interval, calculated as PTF (%) = ([Cmax - Cmin]/Cav ) multiplied by 100
Percentage Peak-Trough Fluctuation (PTF) Post Third Dose of MSB0010841
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
The peak trough fluctuation within one dosing interval, calculated as PTF (%) = ([Cmax - Cmin]/Cav ) multiplied by 100
Accumulation Ratio of Cmax (Racc (Cmax))
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) and 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Accumulation ratio for Cmax was calculated as Cmax, after third dose / Cmax, after first dose.
Accumulation Ratio of AUC (Racc(AUC))
Time frame: 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) and 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)
Accumulation ratio for AUC, calculated as area under the serum concentration-time curve within one complete dosing interval at third dose divided by area under the serum concentration-time curve within one complete dosing interval at first dose.
Maximum Observed Concentration (Cmax) Post Second Dose of MSB0010841
Time frame: 0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15)
Observed Serum Concentration Immediately Before Second Dose (Cpre) of MSB0010841
Time frame: Pre-dose (0 hours) on Day 15
The observed serum concentration immediately before second dose.

5 secondary outcomes

Percentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score
Time frame: Baseline up to Day 85
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43
Time frame: Baseline, Day 43
Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline
Time frame: Day 8, 15, 22, 29, 36, 43, 50, 85
Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85
Time frame: Baseline, Day 8, 15, 22, 29, 36, 43, 50 and 85
Percentage of Subjects With Exacerbation of Psoriasis
Time frame: Baseline up to Day 85

Results and safety

Results posted to the registry on 19 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MSB0010841 30 mg	8	8
MSB0010841 60 mg	8	8
MSB0010841 120 mg	8	7
MSB0010841 240 mg	9	7
Placebo	8	8

Primary outcome: Number of Subjects With Treatment Emergent Adverse Events (TEAEs)

Time frame: Baseline up to Day 85. Number. Unit: subjects

Measure	MSB0010841 30 mg n = 8	MSB0010841 60 mg n = 8	MSB0010841 120 mg n = 8	MSB0010841 240 mg n = 9	Placebo n = 8
Value	6	5	5	6	6

Population analysed: Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo).

Primary outcome: Number of Subjects With Local Injection Site Reactions (ISRs)

Time frame: Day 1, 2,8, 15, 16, 22, 29, 30, 36, 43. Number. Unit: subjects

Measure	MSB0010841 30 mg n = 8	MSB0010841 60 mg n = 8	MSB0010841 120 mg n = 8	MSB0010841 240 mg n = 9	Placebo n = 8
Day 1 Bruising: none (n=8,8,8,9,8)	8	8	8	9	8
Day 1 Indurations: none (n=8,8,8,9,8)	8	8	7	9	8
Day 1 Indurations: mild (n=8,8,8,9,8)	0	0	1	0	0
Day 1 Itching: none (n=8,8,8,9,8)	8	8	8	8	9
Day 1 Itching: mild (n=8,8,8,9,8)	0	0	0	1	0
Day 1 Redness: none (n=8,8,8,9,8)	8	7	8	8	6
Day 1 Redness: mild (n=8,8,8,9,8)	0	1	0	1	2
Day 1 Swelling: none (n=8,8,8,9,8)	8	7	8	9	8

Population analysed: Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo). Here "n" signifies those subjects who were evaluable for the specified injection site reaction. Subjects may be represented in more than 1 category.

Primary outcome: Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)

Time frame: Day 1, 2, 8, 15, 16, 22, 29, 30, 36, 43. Number. Unit: mm

Measure	MSB0010841 30 mg n = 8	MSB0010841 60 mg n = 6	MSB0010841 120 mg n = 8	MSB0010841 240 mg n = 4	Placebo n = 8
Day 1 (n=3,2,3,2,0)	7	4	7	4	NA
Day 2 (n=1,1,1,1,0)	1	1	1	1	NA
Day 8 (n=1,1,0,0,0)	1	1	NA	NA	NA
Day 15 (n=2,1,3,0,0)	5	3	7	NA	NA
Day 16 (n=0,0,0,0,2)	NA	NA	NA	NA	2
Day 22 (1,0,1,0,0)	11	NA	1	NA	NA
Day 29 (n=1,1,1,0,0)	3	2	2	NA	NA
Day 30 (1,0,1,1,0)	2	NA	1	1	NA

Population analysed: Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo). Here "Number of subjects analyzed" signifies those subjects who were evaluable for this endpoint and "n" signifies those subjects who were evaluable at the specified time point.

Primary outcome: Percentage of Subjects With Anti-MSB0010841 Binding Antibodies (Anti-Drug Antibodies [ADA])

Time frame: Baseline up to Day 85. Number. Unit: percentage of subjects

Measure	MSB0010841 Combined n = 33	Placebo n = 8
Value	30.3	37.5

Population analysed: Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo).

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Day 85. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MSB0010841 30 mg	1 of 8 (12.5%)	5 of 8 (62.5%)	Not reported
MSB0010841 60 mg	0 of 8 (0%)	5 of 8 (62.5%)	Not reported
MSB0010841 120 mg	0 of 8 (0%)	5 of 8 (62.5%)	Not reported
MSB0010841 240 mg	0 of 9 (0%)	6 of 9 (66.7%)	Not reported
Placebo	0 of 8 (0%)	6 of 8 (75%)	Not reported

Limitations and caveats (from the sponsor): As AUCextra was more than 20% of AUC0-inf after first dose, AUCextra and all values derived from λz were regarded as implausible and "AUC0-inf", "MRT0-inf", "t1/2", "λz", "CL/f", and "Vz/f" were not calculated after first dose.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Medical Responsible study director

Merck KGaA, Darmstadt, Germany

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MSB0010841 in people with Psoriasis, run by Merck KGaA, Darmstadt, Germany at 1 site in Germany.

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 10 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 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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. Some participants in this study may receive a placebo. 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 19 Jan 2017). 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?

Number of Subjects With Treatment Emergent Adverse Events (TEAEs) (time frame: Baseline up to Day 85). The study lists 38 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 NCT02156466.

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 19 Jan 2017.