18 and older, any sex, with Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Maximum Tolerated Dose (MTD)Primary· 21 days (first treatment course).
MTD is defined as: the dose of BI 6727 which is one dose tier below that dose at which two or more out of a maximum of six patients experienced dose-limiting toxicity (DLT). At the maximum tolerated dose, no more than one patient out of six patients may experience DLT, i.e. MTD is defined as the highest dose studied for which the incidence of dose-limiting toxicity is no more than 17% (i.e. 1/6 patients) during the first course.
DLT is defined as drug related common terminology criteria for adverse events (CTCAE) grade 3 or 4 non haematological toxicity (except emesis or diarrhoea responding
Group
Value
95% CI
BI 6727
400
Number of Participants With Adverse Events (AEs)Secondary· From first drug administration until last drug administration plus 21 days, up to 835 days.
Number of participants with adverse events. The events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v.3.0.
Grade refers to the severity of adverse event. Grade 1: Mild AE; Grade 2: Moderate AE; Grade 3: Severe AE; Grade 4: Life-threatening or disabling AE; Grade 5: Death related to AE.
Grade 1
Group
Value
95% CI
12 mg BI 6727
1
24 mg BI 6727
1
48 mg BI 6727
1
75 mg BI 6727
0
125 mg BI 6727
0
200 mg BI 6727
0
300 mg BI 6727
2
300 mg BI 6727 1h2h
0
300 mg BI 6727 2h1h
0
350 mg BI 6727
1
400 mg BI 6727
1
450 mg BI 6727
0
Grade 2
Group
Value
95% CI
12 mg BI 6727
0
24 mg BI 6727
0
48 mg BI 6727
1
75 mg BI 6727
1
125 mg BI 6727
3
200 mg BI 6727
2
300 mg BI 6727
6
300 mg BI 6727 1h2h
2
300 mg BI 6727 2h1h
3
350 mg BI 6727
0
400 mg BI 6727
1
450 mg BI 6727
0
Grade 3
Group
Value
95% CI
12 mg BI 6727
1
24 mg BI 6727
1
48 mg BI 6727
0
75 mg BI 6727
0
125 mg BI 6727
1
200 mg BI 6727
0
300 mg BI 6727
4
300 mg BI 6727 1h2h
3
300 mg BI 6727 2h1h
2
350 mg BI 6727
2
400 mg BI 6727
2
450 mg BI 6727
0
Grade 4
Group
Value
95% CI
12 mg BI 6727
0
24 mg BI 6727
0
48 mg BI 6727
0
75 mg BI 6727
0
125 mg BI 6727
0
200 mg BI 6727
0
300 mg BI 6727
0
300 mg BI 6727 1h2h
1
300 mg BI 6727 2h1h
1
350 mg BI 6727
1
400 mg BI 6727
6
450 mg BI 6727
2
Grade 5
Group
Value
95% CI
12 mg BI 6727
2
24 mg BI 6727
1
48 mg BI 6727
1
75 mg BI 6727
1
125 mg BI 6727
0
200 mg BI 6727
1
300 mg BI 6727
3
300 mg BI 6727 1h2h
2
300 mg BI 6727 2h1h
0
350 mg BI 6727
0
400 mg BI 6727
0
450 mg BI 6727
0
Number of Participants With Clinically Relevant AbnormalitiesSecondary· From baseline to the last value on treatment, up to 814 days.
Number of participants with clinically relevant abnormalities, occurring in \>5% of the total number of participants, is reported.
Clinically relevant post baseline values with Common Terminology Criteria for Adverse Events (CTCAE) grades:
* CTCAE grade ≥4 for White blood cell count (WBC) , Neutrophils (NEUT), NEUABS Lymphocytes (LMPH) if baseline CTCAE grade is not 4
* CTCAE grade ≥3 for Haemoglobin (HGB), Platelets count (PLTCT), Alkaline phosphatase (ALKP), serum glutamic-oxaloacetic-transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), total bilirubin (TBILI), if baseline CTCA
Haematocrit
Group
Value
95% CI
12 mg BI 6727
1
24 mg BI 6727
2
48 mg BI 6727
1
75 mg BI 6727
1
125 mg BI 6727
2
200 mg BI 6727
3
300 mg BI 6727
10
300 mg BI 6727 1h2h
4
300 mg BI 6727 2h1h
2
350 mg BI 6727
4
400 mg BI 6727
7
450 mg BI 6727
1
Haemoglobin
Group
Value
95% CI
12 mg BI 6727
0
24 mg BI 6727
0
48 mg BI 6727
0
75 mg BI 6727
0
125 mg BI 6727
0
200 mg BI 6727
1
300 mg BI 6727
2
300 mg BI 6727 1h2h
1
300 mg BI 6727 2h1h
1
350 mg BI 6727
2
400 mg BI 6727
3
450 mg BI 6727
0
Mean corpuscular volume (MCV)
Group
Value
95% CI
12 mg BI 6727
0
24 mg BI 6727
1
48 mg BI 6727
0
75 mg BI 6727
1
125 mg BI 6727
0
200 mg BI 6727
1
300 mg BI 6727
2
300 mg BI 6727 1h2h
1
300 mg BI 6727 2h1h
1
350 mg BI 6727
0
400 mg BI 6727
2
450 mg BI 6727
1
Platelets
Group
Value
95% CI
12 mg BI 6727
0
24 mg BI 6727
0
48 mg BI 6727
0
75 mg BI 6727
0
125 mg BI 6727
0
200 mg BI 6727
0
300 mg BI 6727
2
300 mg BI 6727 1h2h
0
300 mg BI 6727 2h1h
2
350 mg BI 6727
1
400 mg BI 6727
4
450 mg BI 6727
2
Red blood cell count (RBC)
Group
Value
95% CI
12 mg BI 6727
0
24 mg BI 6727
0
48 mg BI 6727
1
75 mg BI 6727
1
125 mg BI 6727
2
200 mg BI 6727
2
300 mg BI 6727
7
300 mg BI 6727 1h2h
4
300 mg BI 6727 2h1h
1
350 mg BI 6727
3
400 mg BI 6727
4
450 mg BI 6727
2
White blood cell count (WBC)
Group
Value
95% CI
12 mg BI 6727
0
24 mg BI 6727
0
48 mg BI 6727
0
75 mg BI 6727
0
125 mg BI 6727
0
200 mg BI 6727
0
300 mg BI 6727
1
300 mg BI 6727 1h2h
0
300 mg BI 6727 2h1h
1
350 mg BI 6727
2
400 mg BI 6727
2
450 mg BI 6727
0
Neutrophils
Group
Value
95% CI
12 mg BI 6727
0
24 mg BI 6727
0
48 mg BI 6727
0
75 mg BI 6727
0
125 mg BI 6727
0
200 mg BI 6727
0
300 mg BI 6727
2
300 mg BI 6727 1h2h
2
300 mg BI 6727 2h1h
1
350 mg BI 6727
2
400 mg BI 6727
6
450 mg BI 6727
2
Sodium
Group
Value
95% CI
12 mg BI 6727
0
24 mg BI 6727
0
48 mg BI 6727
1
75 mg BI 6727
0
125 mg BI 6727
0
200 mg BI 6727
0
300 mg BI 6727
1
300 mg BI 6727 1h2h
1
300 mg BI 6727 2h1h
0
350 mg BI 6727
1
400 mg BI 6727
2
450 mg BI 6727
0
Number of Participants With Change in Eastern Cooperative Oncology Group (ECOG) Patient Performance ScoreSecondary· At baseline and at end of treatment (up to 814 days).
ECOG score: The scale of ECOG score is defined as a six point categorical scale as described ranging from 0 (asymptomatic) to 5 (death). ECOG score change from baseline to end of treatment is calculated, and defined as
= ECOG score at end of treatment - ECOG score at baseline.
Scale of ECOG score change:
The ECOG score changes from baseline score are categorized on a three point categorical scale: Improved, unchanged, and deteriorated. Improvement or deterioration of performance status required a decrease or an increase from baseline, respectively, of at least one point on the ECOG scale. T
Improved
Group
Value
95% CI
12 mg BI 6727
0
24 mg BI 6727
0
48 mg BI 6727
0
75 mg BI 6727
0
125 mg BI 6727
0
200 mg BI 6727
0
300 mg BI 6727
0
300 mg BI 6727 1h2h
0
300 mg BI 6727 2h1h
0
350 mg BI 6727
0
400 mg BI 6727
0
450 mg BI 6727
0
Unchanged
Group
Value
95% CI
12 mg BI 6727
1
24 mg BI 6727
2
48 mg BI 6727
1
75 mg BI 6727
1
125 mg BI 6727
1
200 mg BI 6727
2
300 mg BI 6727
7
300 mg BI 6727 1h2h
2
300 mg BI 6727 2h1h
2
350 mg BI 6727
3
400 mg BI 6727
2
450 mg BI 6727
0
Deteriorated
Group
Value
95% CI
12 mg BI 6727
2
24 mg BI 6727
1
48 mg BI 6727
2
75 mg BI 6727
1
125 mg BI 6727
3
200 mg BI 6727
1
300 mg BI 6727
7
300 mg BI 6727 1h2h
5
300 mg BI 6727 2h1h
4
350 mg BI 6727
2
400 mg BI 6727
8
450 mg BI 6727
2
Unknown
Group
Value
95% CI
12 mg BI 6727
1
24 mg BI 6727
0
48 mg BI 6727
0
75 mg BI 6727
0
125 mg BI 6727
0
200 mg BI 6727
0
300 mg BI 6727
1
300 mg BI 6727 1h2h
1
300 mg BI 6727 2h1h
0
350 mg BI 6727
0
400 mg BI 6727
0
450 mg BI 6727
0
Electrocardiogram (ECG) - QTcF Change From BaselineSecondary· At baseline and 5 minutes before infusion end, 1 hour after end of infusion and at 4 and 12 hours after start of infusion, at course 1.
Electrocardiogram (ECG) - QTcF change from baseline. QTcF intervals form the ECGs were analysed for changes during and after intravenous infusion of BI 300 mg dose over 1 hours and over 2 hours. For baseline ECG, the combined baseline, defined as the mean of the 2 triplicates at the time-point closest to but prior to the start of the infusion of both treatment courses, i.e. a common baseline is used for both treatment courses, was used. Mean is adjusted mean.
Abbreviations:
QTcF: QT interval, corrected for heart rate according to Fridericia's formula (seconds) = measured QT / (cube root of p
CfB to 5 minutes before infusion end
Group
Value
95% CI
300 mg BI 6727 1h
17.79
13.68 – 21.90
300 mg BI 6727 2h
13.23
8.83 – 17.64
CfB to 1 hours after infusion end
Group
Value
95% CI
300 mg BI 6727 1h
13.99
9.88 – 18.10
300 mg BI 6727 2h
6.84
2.44 – 11.25
CfB to 4 hours after infusion start
Group
Value
95% CI
300 mg BI 6727 1h
10.65
6.54 – 14.76
300 mg BI 6727 2h
7.08
2.67 – 11.48
CfB to 24 hours after infusion start
Group
Value
95% CI
300 mg BI 6727 1h
4.33
0.22 – 8.44
300 mg BI 6727 2h
-4.33
-8.73 – 0.07
Vital Signs - Blood PressureSecondary· At baseline.
Systolic blood pressure and diastolic blood pressure are reported.
Systolic blood pressure
Group
Value
95% CI
12 mg BI 6727
126
110 – 155
24 mg BI 6727
124
107 – 148
48 mg BI 6727
124
110 – 134
75 mg BI 6727
112
100 – 124
125 mg BI 6727
110
99 – 131
200 mg BI 6727
130
116 – 164
300 mg BI 6727
125
102 – 172
300 mg BI 6727 1h2h
129
100 – 146
300 mg BI 6727 2h1h
148
120 – 165
350 mg BI 6727
135
110 – 149
400 mg BI 6727
144
88 – 178
450 mg BI 6727
129
128 – 130
Diastolic blood pressure
Group
Value
95% CI
12 mg BI 6727
74
60 – 80
24 mg BI 6727
80
68 – 90
48 mg BI 6727
78
78 – 85
75 mg BI 6727
75
70 – 80
125 mg BI 6727
71.5
58 – 80
200 mg BI 6727
76
72 – 90
300 mg BI 6727
80
69 – 98
300 mg BI 6727 1h2h
78.5
67 – 89
300 mg BI 6727 2h1h
86.5
60 – 100
350 mg BI 6727
82
70 – 90
400 mg BI 6727
81.5
45 – 100
450 mg BI 6727
75
70 – 80
Vital Signs - Pulse RateSecondary· At baseline.
Pulse rate is reported.
Group
Value
95% CI
12 mg BI 6727
88
76 – 92
24 mg BI 6727
80
72 – 98
48 mg BI 6727
88
73 – 92
75 mg BI 6727
92
88 – 96
125 mg BI 6727
91
84 – 99
200 mg BI 6727
88
66 – 96
300 mg BI 6727
78
64 – 120
300 mg BI 6727 1h2h
84
59 – 97
300 mg BI 6727 2h1h
75
58 – 104
350 mg BI 6727
76
67 – 100
400 mg BI 6727
82
62 – 114
450 mg BI 6727
76
74 – 78
Number of Participants With Unconfirmed Best Overall ResponseSecondary· Up to 814 days.
For solid tumours, evaluation of tumour response was assessed according to the Response Evaluation Criteria in Solid Tumours (RECIST) definition. The overall response of target and non-target lesions together with or without the appearance of new lesions as reported by the investigator was assessed on a four point categorical scale as complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) according to the RECIST criteria. In order to best handle measurements that were non-evaluable (NEV) a modified version of the RECIST criteria was used. If a RECIST o
Number of Participants With ProgressionSecondary· Up to 814 days.
Number of participants with progression of disease.
Progressive disease is defined according to the Response Evaluation Criteria in Solid Tumours (RECIST) as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter.
Group
Value
95% CI
12 mg BI 6727
3
24 mg BI 6727
3
48 mg BI 6727
3
75 mg BI 6727
2
125 mg BI 6727
4
200 mg BI 6727
3
300 mg BI 6727
15
300 mg BI 6727 1h2h
7
300 mg BI 6727 2h1h
6
350 mg BI 6727
5
400 mg BI 6727
10
450 mg BI 6727
1
Maximum Concentration of BI 6727 in Plasma (Cmax)Secondary· At course 1: 0.083 hours before drug administration and at 0.25, 0.5, 075, 1*, 1.5, 2, 4, 8, 24, 48, 96, 168, 336 hours after start of infusion (*immediately prior to end of infusion of BI 6727).
Maximum concentration of BI 6727 in plasma (Cmax).
Different time frame for dose groups 300 mg BI 6727 1h2h and 300 mg BI 6727 2h1h:
For 300mg BI 6727 1h2h: At course 1: 0.083 hours before drug administration and at 1\*, 2, 4, 8, 24 hours after start of infusion (\*immediately prior to end of infusion of BI 6727).
For 300mg BI 6727 2h1h: At course 1: 0.083 hours before drug administration and at 1\*, 2, 3, 4 and 24 hours after start of infusion (\*immediately prior to end of infusion of BI 6727).
Group
Value
95% CI
12 mg BI 6727
18.8
± 14.3
24 mg BI 6727
50.7
± 12.4
48 mg BI 6727
91.1
± 17.6
75 mg BI 6727
169.0
± 11.7
125 mg BI 6727
234.0
± 30.9
200 mg BI 6727
470.0
± 57.6
300 mg BI 6727
758
± 28.8
300 mg BI 6727 1h2h
519.0
± 60.3
300 mg BI 6727 2h1h
246.0
± 68.8
350 mg BI 6727
724.0
± 23.6
400 mg BI 6727
1020.0
± 20.9
450 mg BI 6727
1450.0
± 8.81
Time From Dosing to Maximum Concentration (Tmax)Secondary· At course 1: 0.083 hours before drug administration and at 0.25, 0.5, 075, 1*, 1.5, 2, 4, 8, 24, 48, 96, 168, 336 hours after start of infusion (*immediately prior to end of infusion of BI 6727).
Time from dosing to maximum concentration (tmax).
Different time frame for dose groups 300 mg BI 6727 1h2h and 300 mg BI 6727 2h1h:
For 300mg BI 6727 1h2h: At course 1: 0.083 hours before drug administration and at 1\*, 2, 4, 8, 24 hours after start of infusion (\*immediately prior to end of infusion of BI 6727).
For 300mg BI 6727 2h1h: At course 1: 0.083 hours before drug administration and at 1\*, 2, 3, 4 and 24 hours after start of infusion (\*immediately prior to end of infusion of BI 6727).
Group
Value
95% CI
12 mg BI 6727
0.667
0.500 – 0.750
24 mg BI 6727
0.750
0.750 – 1.25
48 mg BI 6727
0.500
0.250 – 0.533
75 mg BI 6727
0.884
0.767 – 1.00
125 mg BI 6727
0.533
0.500 – 0.733
200 mg BI 6727
1.00
0.500 – 1.03
300 mg BI 6727
0.750
0.500 – 1.00
300 mg BI 6727 1h2h
1.00
0.967 – 1.01
300 mg BI 6727 2h1h
2.00
1.98 – 2.00
350 mg BI 6727
0.750
0.750 – 0.867
400 mg BI 6727
0.750
0.250 – 1.00
450 mg BI 6727
0.517
0.250 – 0.783
Area Under the Concentration-time Curve of BI 6727 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)Secondary· 0.083 hours before drug administration and at 0.25, 0.5, 075, 1*, 1.5, 2, 4, 8, 24, 48, 96, 168, 336 and 504 hours after start of infusion. (*Immediately prior to end of infusion of BI 6727).
Area under the concentration-time curve of BI 6727 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).
Group
Value
95% CI
12 mg BI 6727
149
± 31.6
24 mg BI 6727
380
± 38.9
48 mg BI 6727
778
± 25.1
75 mg BI 6727
1270
± 7.64
125 mg BI 6727
2140
± 27.9
200 mg BI 6727
5670
± 36.7
300 mg BI 6727
6540
± 32.6
350 mg BI 6727
10000
± 57.6
400 mg BI 6727
7510
± 19.3
450 mg BI 6727
10900
± 14.0
Adverse events — posted to ClinicalTrials.gov
Time frame: From first drug administration until last drug administration plus 21 days, up to 835 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
12 mg BI 6727
Serious: 3/4 (75%)
Deaths: 3/4
24 mg BI 6727
Serious: 2/3 (67%)
Deaths: 2/3
48 mg BI 6727
Serious: 2/3 (67%)
Deaths: 1/3
75 mg BI 6727
Serious: 1/2 (50%)
Deaths: 1/2
125 mg BI 6727
Serious: 0/4 (0%)
Deaths: 1/4
200 mg BI 6727
Serious: 2/3 (67%)
Deaths: 1/3
300 mg BI 6727
Serious: 9/15 (60%)
Deaths: 6/15
300 mg BI 6727 1h2h
Serious: 3/8 (38%)
Deaths: 4/8
300 mg BI 6727 2h1h
Serious: 1/6 (17%)
Deaths: 2/6
350 mg BI 6727
Serious: 3/5 (60%)
Deaths: 0/5
400 mg BI 6727
Serious: 5/10 (50%)
Deaths: 2/10
450 mg BI 6727
Serious: 2/2 (100%)
Deaths: 0/2
Serious adverse events (42 terms)
Reaction
System
12 mg BI 6727
24 mg BI 6727
48 mg BI 6727
75 mg BI 6727
125 mg BI 6727
200 mg BI 6727
300 mg BI 6727
300 mg BI 6727 1h2h
300 mg BI 6727 2h1h
350 mg BI 6727
400 mg BI 6727
450 mg BI 6727
Anaemia
Blood and lymphatic system disorders
—
—
—
—
—
—
—
—
—
—
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
—
—
—
—
—
—
—
—
—
—
Thrombocytopenia
Blood and lymphatic system disorders
—
—
—
—
—
—
—
—
—
—
—
—
General physical health deterioration
General disorders
—
—
—
—
—
—
—
—
—
—
—
—
Leukopenia
Blood and lymphatic system disorders
—
—
—
—
—
—
—
—
—
—
—
—
Neutropenia
Blood and lymphatic system disorders
—
—
—
—
—
—
—
—
—
—
—
—
Angina pectoris
Cardiac disorders
—
—
—
—
—
—
—
—
—
—
—
—
Vision blurred
Eye disorders
—
—
—
—
—
—
—
—
—
—
—
—
Abdominal pain
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
—
—
Abdominal pain upper
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
—
—
Intestinal obstruction
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
—
—
Mesenteric artery stenosis
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
—
—
Nausea
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
—
—
Thrombosis mesenteric vessel
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
—
—
Volvulus
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
—
—
Vomiting
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
—
—
Fatigue
General disorders
—
—
—
—
—
—
—
—
—
—
—
—
Pyrexia
General disorders
—
—
—
—
—
—
—
—
—
—
—
—
Appendicitis
Infections and infestations
—
—
—
—
—
—
—
—
—
—
—
—
Fusobacterium infection
Infections and infestations
—
—
—
—
—
—
—
—
—
—
—
—
Infection
Infections and infestations
—
—
—
—
—
—
—
—
—
—
—
—
Lung infection
Infections and infestations
—
—
—
—
—
—
—
—
—
—
—
—
Pneumonia
Infections and infestations
—
—
—
—
—
—
—
—
—
—
—
—
Septic shock
Infections and infestations
—
—
—
—
—
—
—
—
—
—
—
—
Skin infection
Infections and infestations
—
—
—
—
—
—
—
—
—
—
—
—
Other adverse events (126 terms — click to expand)
The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI 6727 therapy in terms of drug-related adverse events. Secondary objectives are the collection of overall safety and antitumour efficacy data and the determination of the pharmacokinetic profile of BI 6727.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
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· Phase 3
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 3 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02273388.