Psoriatic ArthritisPhase 1NCT02141763
Multiple Dose Study of UCB4940 in Subjects With Psoriatic Arthritis
A Phase 1 study testing UCB4940 40 mg, UCB4940 80 mg and UCB4940 160 mg in people with Psoriatic Arthritis, run by UCB Celltech at 3 sites in 3 countries.
Trial summary
A study of UCB4940 in subjects with psoriatic arthritis to evaluate the safety and body distribution of UCB4940 in those patients. Neither the patient nor the doctor will know the treatment group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- UCB4940 40 mg, UCB4940 80 mg and UCB4940 160 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 3 sitesin 3 countries
- Study dates
- May 2014to Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of adult-onset psoriatic arthritis made at least 6 months prior to Screening as defined by the Classification Criteria for Psoriatic Arthritis
- Subject must have active psoriatic lesions or a history of psoriatic skin lesions
- Subject must have active arthritis
- Subject has had inadequate response to at least 1 nonbiologic Disease-Modifying Antirheumatic Drug (DMARD) (which may include methotrexate [MTX]) and/or 1 approved biologic DMARD
- Subject must be taking concurrent MTX for at least 3 months at time of Screening, and be on a stable dose at least 4 weeks prior to Baseline
- Female subject must be postmenopausal (at least 1 year), permanently sterilized or, if of childbearing potential, must be willing to use at least 2 effective methods of contraception during the study period
- Subject has clinical laboratory test results within the reference ranges of the testing laboratory
- Subject has Electrocardiogram (ECG) values within the reference ranges of the testing laboratory
Who cannot join
- Subject has absolute neutrophil count <1.5×109/L, and/or lymphocyte count <1.0×109/L
- Subject has known viral hepatitis, has a positive test for hepatitis B surface antigen or is hepatitis C virus antibody positive
- Subject tests positive to human immunodeficiency virus (HIV)-1/2 antibody
- Subject has a past medical history or family history of primary immunodeficiency
- Subject is splenectomized
- Subject has had a severe infection requiring hospitalization and/or treatment with iv antibiotics in the 6 months before the Screening Visit
Show all 19Show fewer
- Subject has a history of positive tuberculosis (TB) test or evidence of possible TB or latent TB infection at Screening
- Subject has a high risk of acquiring TB infection
- Subject has a history of alcoholism or drug/chemical abuse
- Subject has an active infection or has had a serious within 6 weeks before the first dose of Investigational Medicinal Product (IMP)
- Subject has renal or liver impairment at the Screening Visit
- Subject has active neoplastic disease or history of neoplastic disease within 5 years of study entry (except for basal or squamous cell carcinoma of the skin or carcinoma in situ which has been definitively treated with standard of care approaches and is considered cured at Screening)
- Subject has any other acute or chronic illness which, in the opinion of the Investigator or Study Physician, could pose a threat or harm to the subject
- Subjects must not have a diagnosis of any other inflammatory arthritis, eg, rheumatoid arthritis, sarcoidosis, or systemic lupus erythematosus
- Subject has a current or past history of gastrointestinal ulceration
- Subjects must not have a noninflammatory condition (eg, osteoarthritis or a known diagnosis of fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of IMP on the subject's primary diagnosis of Psoriatic Arthritis (PsA)
- Subject has received a live vaccination within 6 weeks before the Screening Visit or intends to have or will need a live vaccination during the course of the study or for the 3 months following last IMP dosing
- Subject has had an inadequate response to more than 1 approved biologic Drug-Modifying Antirheumatic Drug (DMARD)
- Subject has received any investigational drug or experimental procedure within 90 days or 5 half-lives whichever is the longer before the first dose of UCB4940
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Subject-blind, Investigator-blind, Randomized, Placebo-controlled Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of UCB4940 in Subjects With Psoriatic Arthritis
A study of UCB4940 in subjects with psoriatic arthritis to evaluate the safety and body distribution of UCB4940 in those patients. Neither the patient nor the doctor will know the treatment group.
- Conditions
- Psoriatic Arthritis
- Being tested
- UCB4940 40 mg, UCB4940 80 mg, UCB4940 160 mg, UCB4940 240 mg, UCB4940 320 mg
- Keywords
- Psoriatic Arthritis
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCB4940 40 mgDrug
- Active Substance: UCB4940
- Pharmaceutical Form: solution
- Concentration: vials at 80 mg/mL will be diluted with 0.9 % sodium chloride to a final concentration calculated to achieve the correct dose
- Route of Administration: intravenous
UCB4940 80 mgDrug
- Active Substance: UCB4940
- Pharmaceutical Form: solution
- Concentration: vials at 80 mg/mL will be diluted with 0.9 % sodium chloride to a final concentration calculated to achieve the correct dose
- Route of Administration: intravenous
UCB4940 160 mgDrug
- Active Substance: UCB4940
- Pharmaceutical Form: solution
- Concentration: vials at 80 mg/mL will be diluted with 0.9 % sodium chloride to a final concentration calculated to achieve the correct dose
- Route of Administration: intravenous
UCB4940 240 mgDrug
- Active Substance: UCB4940
- Pharmaceutical Form: solution
- Concentration: vials at 80 mg/mL will be diluted with 0.9 % sodium chloride to a final concentration calculated to achieve the correct dose
- Route of Administration: intravenous
UCB4940 320 mgDrug
- Active Substance: UCB4940
- Pharmaceutical Form: solution
- Concentration: vials at 80 mg/mL will be diluted with 0.9 % sodium chloride to a final concentration calculated to achieve the correct dose
- Route of Administration: intravenous
UCB4940 560 mgDrug
- Active Substance: UCB4940
- Pharmaceutical Form: solution
- Concentration: vials at 80 mg/mL will be diluted with 0.9 % sodium chloride to a final concentration calculated to achieve the correct dose
- Route of Administration: intravenous
PlaceboOther
- Pharmaceutical Form: solution
- Concentration: 0.9 % sodium chloride
- Route of Administration: intravenous
| Study group | Role | What they receive |
|---|---|---|
| 240/160/160 mg of UCB4940 | Experimental | 240 mg loading dose + 160 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses) Receives: Drug: UCB4940 160 mg; Drug: UCB4940 240 mg; Other: Placebo |
| 160/80/80 mg of UCB4940 | Experimental | 160 mg loading dose + 80 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses) Receives: Drug: UCB4940 80 mg; Drug: UCB4940 160 mg; Other: Placebo |
| 80/40/40 mg of UCB4940 | Experimental | 80 mg loading dose + 40 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses) Receives: Drug: UCB4940 40 mg; Drug: UCB4940 80 mg; Other: Placebo |
| 560/320/320 mg of UCB4940 | Experimental | 560 mg loading dose + 320 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses) Receives: Drug: UCB4940 320 mg; Drug: UCB4940 560 mg; Other: Placebo |
| Placebo | Placebo comparator | 0.9% sodium chloride aqueous solution (physiological saline, preservative free) of pharmacopoeia (USP/Ph.Eur) quality in a 10 mL glass vial Receives: Drug: UCB4940 40 mg; Drug: UCB4940 80 mg; Drug: UCB4940 160 mg; Drug: UCB4940 240 mg; Drug: UCB4940 320 mg; Drug: UCB4940 560 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration at steady state (CmaxSS) of UCB 4940 during the duration of the study (up to Day 141)
- Day 1: predose; 1 hour (hr), 1.5 hr, 5 hr, 12 hr, 24 hr postdose
- Day 8, 15: 1 sample
- Day 22: predose, 1 hr postdose
- Day 43: predose; 1 hr, 1.5 hr, 5 hr, 12 hr, 24 hr postdose
- Day 48, 57, 64, 85, 141: 1 sample
Measured: From Baseline to Day 141
Minimum plasma concentration at steady state (CminSS) of UCB4940 during the duration of the study (up to Day 141)
- Day 1: predose; 1 hour (hr), 1.5 hr, 5 hr, 12 hr, 24 hr postdose
- Day 8, 15: 1 sample
- Day 22: predose, 1 hr postdose
- Day 43: predose; 1 hr, 1.5 hr, 5 hr, 12 hr, 24 hr postdose
- Day 48, 57, 64, 85, 141: 1 sample
Measured: From Baseline to Day 141
Area under the curve at steady state (AUCtau) of UCB4940 during the duration of the study (up to Day 141)
- Day 1: predose; 1 hour (hr), 1.5 hr, 5 hr, 12 hr, 24 hr postdose
- Day 8, 15: 1 sample
- Day 22: predose, 1 hr postdose
- Day 43: predose; 1 hr, 1.5 hr, 5 hr, 12 hr, 24 hr postdose
- Day 48, 57, 64, 85, 141: 1 sample
Measured: From Baseline to Day 141
Time to reach maximum plasma concentration at steady state (tmax) of UCB4940 during the duration of the study (up to Day 141)
- Day 1: predose; 1 hour (hr), 1.5 hr, 5 hr, 12 hr, 24 hr postdose
- Day 8, 15: 1 sample
- Day 22: predose, 1 hr postdose
- Day 43: predose; 1 hr, 1.5 hr, 5 hr, 12 hr, 24 hr postdose
- Day 48, 57, 64, 85, 141: 1 sample
Measured: From Baseline to Day 141
Total Clearance (CL) of UCB4940 during the duration of the study (up to Day 141)
- Day 1: predose; 1 hour (hr), 1.5 hr, 5 hr, 12 hr, 24 hr postdose
- Day 8, 15: 1 sample
- Day 22: predose, 1 hr postdose
- Day 43: predose; 1 hr, 1.5 hr, 5 hr, 12 hr, 24 hr postdose
- Day 48, 57, 64, 85, 141: 1 sample
Measured: From Baseline to Day 141
Volume of distribution (V) of UCB4940 during the duration of the study (up to Day 141)
- Day 1: predose; 1 hour (hr), 1.5 hr, 5 hr, 12 hr, 24 hr postdose
- Day 8, 15: 1 sample
- Day 22: predose, 1 hr postdose
- Day 43: predose; 1 hr, 1.5 hr, 5 hr, 12 hr, 24 hr postdose
- Day 48, 57, 64, 85, 141: 1 sample
Measured: From Baseline to Day 141
Percentage of subjects with at least one Treatment Emergent Adverse Event (TEAE) during the study
Measured: From Baseline to Day 141
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2014 (estimated)
- Study startMay 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Celltech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel, MAC Clinical Research, Comac Medical, ARENSIA, Moldova
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141763
- Sponsor's protocol ID
- PA0007
- Other IDs
- 2013-004949-16
- Status last verified
- Aug 2015
- First submitted
- 15 May 2014
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Glatt S, Baeten D, Baker T, Griffiths M, Ionescu L, Lawson ADG, Maroof A, Oliver R, Popa S, Strimenopoulou F, Vajjah P, Watling MIL, Yeremenko N, Miossec P, Shaw S. Dual IL-17A and IL-17F neutralisation by bimekizumab in psoriatic arthritis: evidence from preclinical experiments and a randomised placebo-controlled clinical trial that IL-17F contributes to human chronic tissue inflammation. Ann Rheum Dis. 2018 Apr;77(4):523-532. doi: 10.1136/annrheumdis-2017-212127. Epub 2017 Dec 23.
PubMed 29275332
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Subject-blind, Investigator-blind, Randomized, Placebo-controlled Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of UCB4940 in Subjects With Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT02141763
- Acronym / sponsor ID
- PA0007
- Conditions
- Psoriatic Arthritis
- Keywords
- Psoriatic Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- UCB CelltechIndustry (pharma, biotech, devices)
- Collaborators
- Parexel, MAC Clinical Research, Comac Medical, ARENSIA, Moldova
- Study start
- May 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 19 May 2014 (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.
A study of UCB4940 in subjects with psoriatic arthritis to evaluate the safety and body distribution of UCB4940 in those patients. Neither the patient nor the doctor will know the treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 240/160/160 mg of UCB4940 | Experimental | Drug: UCB4940 160 mg, Drug: UCB4940 240 mg, Other: Placebo240 mg loading dose + 160 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses) |
| 160/80/80 mg of UCB4940 | Experimental | Drug: UCB4940 80 mg, Drug: UCB4940 160 mg, Other: Placebo160 mg loading dose + 80 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses) |
| 80/40/40 mg of UCB4940 | Experimental | Drug: UCB4940 40 mg, Drug: UCB4940 80 mg, Other: Placebo80 mg loading dose + 40 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses) |
| 560/320/320 mg of UCB4940 | Experimental | Drug: UCB4940 320 mg, Drug: UCB4940 560 mg, Other: Placebo560 mg loading dose + 320 mg maintenance dose every 3 weeks on 2 occasions (total 3 doses) |
| Placebo | Placebo comparator | Drug: UCB4940 40 mg, Drug: UCB4940 80 mg, Drug: UCB4940 160 mg, Drug: UCB4940 240 mg, Drug: UCB4940 320 mg, Drug: UCB4940 560 mg0.9% sodium chloride aqueous solution (physiological saline, preservative free) of pharmacopoeia (USP/Ph.Eur) quality in a 10 mL glass vial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have a diagnosis of adult-onset psoriatic arthritis made at least 6 months prior to Screening as defined by the Classification Criteria for Psoriatic Arthritis
- Subject must have active psoriatic lesions or a history of psoriatic skin lesions
- Subject must have active arthritis
- Subject has had inadequate response to at least 1 nonbiologic Disease-Modifying Antirheumatic Drug (DMARD) (which may include methotrexate [MTX]) and/or 1 approved biologic DMARD
- Subject must be taking concurrent MTX for at least 3 months at time of Screening, and be on a stable dose at least 4 weeks prior to Baseline
Key exclusion criteria (19 listed)
- Subject has absolute neutrophil count <1.5×109/L, and/or lymphocyte count <1.0×109/L
- Subject has known viral hepatitis, has a positive test for hepatitis B surface antigen or is hepatitis C virus antibody positive
- Subject tests positive to human immunodeficiency virus (HIV)-1/2 antibody
- Subject has a past medical history or family history of primary immunodeficiency
- Subject is splenectomized
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 |
|---|---|---|
| UCB4940 40 mg* Active Substance: UCB4940 * Pharmaceutical Form: solution * Concentration: vials at 80 mg/mL will be diluted with 0.9 % sodium chloride to a final concentration calculated to achieve the correct dose * Route of Administration: intravenous | Drug | 80/40/40 mg of UCB4940, Placebo |
| UCB4940 80 mg* Active Substance: UCB4940 * Pharmaceutical Form: solution * Concentration: vials at 80 mg/mL will be diluted with 0.9 % sodium chloride to a final concentration calculated to achieve the correct dose * Route of Administration: intravenous | Drug | 160/80/80 mg of UCB4940, 80/40/40 mg of UCB4940, Placebo |
| UCB4940 160 mg* Active Substance: UCB4940 * Pharmaceutical Form: solution * Concentration: vials at 80 mg/mL will be diluted with 0.9 % sodium chloride to a final concentration calculated to achieve the correct dose * Route of Administration: intravenous | Drug | 160/80/80 mg of UCB4940, 240/160/160 mg of UCB4940, Placebo |
| UCB4940 240 mg* Active Substance: UCB4940 * Pharmaceutical Form: solution * Concentration: vials at 80 mg/mL will be diluted with 0.9 % sodium chloride to a final concentration calculated to achieve the correct dose * Route of Administration: intravenous | Drug | 240/160/160 mg of UCB4940, Placebo |
| UCB4940 320 mg* Active Substance: UCB4940 * Pharmaceutical Form: solution * Concentration: vials at 80 mg/mL will be diluted with 0.9 % sodium chloride to a final concentration calculated to achieve the correct dose * Route of Administration: intravenous | Drug | 560/320/320 mg of UCB4940, Placebo |
| UCB4940 560 mg* Active Substance: UCB4940 * Pharmaceutical Form: solution * Concentration: vials at 80 mg/mL will be diluted with 0.9 % sodium chloride to a final concentration calculated to achieve the correct dose * Route of Administration: intravenous | Drug | 560/320/320 mg of UCB4940, Placebo |
| Placebo* Pharmaceutical Form: solution * Concentration: 0.9 % sodium chloride * Route of Administration: intravenous | Other | 160/80/80 mg of UCB4940, 240/160/160 mg of UCB4940, 560/320/320 mg of UCB4940, 80/40/40 mg of UCB4940 |
Primary outcome
Maximum plasma concentration at steady state (CmaxSS) of UCB 4940 during the duration of the study (up to Day 141)
Time frame: From Baseline to Day 141
* Day 1: predose; 1 hour (hr), 1.5 hr, 5 hr, 12 hr, 24 hr postdose * Day 8, 15: 1 sample * Day 22: predose, 1 hr postdose * Day 43: predose; 1 hr, 1.5 hr, 5 hr, 12 hr, 24 hr postdose * Day 48, 57, 64, 85, 141: 1 sample
Minimum plasma concentration at steady state (CminSS) of UCB4940 during the duration of the study (up to Day 141)
Time frame: From Baseline to Day 141
* Day 1: predose; 1 hour (hr), 1.5 hr, 5 hr, 12 hr, 24 hr postdose * Day 8, 15: 1 sample * Day 22: predose, 1 hr postdose * Day 43: predose; 1 hr, 1.5 hr, 5 hr, 12 hr, 24 hr postdose * Day 48, 57, 64, 85, 141: 1 sample
Area under the curve at steady state (AUCtau) of UCB4940 during the duration of the study (up to Day 141)
Time frame: From Baseline to Day 141
* Day 1: predose; 1 hour (hr), 1.5 hr, 5 hr, 12 hr, 24 hr postdose * Day 8, 15: 1 sample * Day 22: predose, 1 hr postdose * Day 43: predose; 1 hr, 1.5 hr, 5 hr, 12 hr, 24 hr postdose * Day 48, 57, 64, 85, 141: 1 sample
Time to reach maximum plasma concentration at steady state (tmax) of UCB4940 during the duration of the study (up to Day 141)
Time frame: From Baseline to Day 141
* Day 1: predose; 1 hour (hr), 1.5 hr, 5 hr, 12 hr, 24 hr postdose * Day 8, 15: 1 sample * Day 22: predose, 1 hr postdose * Day 43: predose; 1 hr, 1.5 hr, 5 hr, 12 hr, 24 hr postdose * Day 48, 57, 64, 85, 141: 1 sample
Total Clearance (CL) of UCB4940 during the duration of the study (up to Day 141)
Time frame: From Baseline to Day 141
* Day 1: predose; 1 hour (hr), 1.5 hr, 5 hr, 12 hr, 24 hr postdose * Day 8, 15: 1 sample * Day 22: predose, 1 hr postdose * Day 43: predose; 1 hr, 1.5 hr, 5 hr, 12 hr, 24 hr postdose * Day 48, 57, 64, 85, 141: 1 sample
Volume of distribution (V) of UCB4940 during the duration of the study (up to Day 141)
Time frame: From Baseline to Day 141
* Day 1: predose; 1 hour (hr), 1.5 hr, 5 hr, 12 hr, 24 hr postdose * Day 8, 15: 1 sample * Day 22: predose, 1 hr postdose * Day 43: predose; 1 hr, 1.5 hr, 5 hr, 12 hr, 24 hr postdose * Day 48, 57, 64, 85, 141: 1 sample
Percentage of subjects with at least one Treatment Emergent Adverse Event (TEAE) during the study
Time frame: From Baseline to Day 141
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 1 Sep 2015.
- Derived from this study: PubMed 29275332Glatt S, Baeten D, Baker T, Griffiths M, Ionescu L, Lawson ADG, Maroof A, Oliver R, Popa S, Strimenopoulou F, Vajjah P, Watling MIL, Yeremenko N, Miossec P, Shaw S. Dual IL-17A and IL-17F neutralisation by bimekizumab in psoriatic arthritis: evidence from preclinical experiments and a randomised placebo-controlled clinical trial that IL-17F contributes to human chronic tissue inflammation. Ann Rheum Dis. 2018 Apr;77(4):523-532. doi: 10.1136/annrheumdis-2017-212127. Epub 2017 Dec 23.
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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.
UCB Clinical Trial Call Center study director
UCB Pharma
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UCB4940 40 mg, UCB4940 80 mg and UCB4940 160 mg in people with Psoriatic Arthritis, run by UCB Celltech at 3 sites in 3 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 8 inclusion and 19 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 1 Sep 2015. 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 Bulgaria, Moldova, 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. 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?
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?
Maximum plasma concentration at steady state (CmaxSS) of UCB 4940 during the duration of the study (up to Day 141) (time frame: From Baseline to Day 141). The study lists 7 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 NCT02141763, which also lists 1 linked publication.
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 1 Sep 2015.